Telemedicine Chapter 5: Telemedicine and Chronic Obstructive Pulmonary Disease
Hong and Lee (2019) [Systematic Review and Meta-Analysis] Effectiveness of Tele-Monitoring by Patient Severity and Intervention Type in Chronic Obstructive Pulmonary Disease Patients: A Systematic Review and Meta-Analysis
Background: Chronic obstructive pulmonary disease is a major burden on healthcare systems worldwide. Tele-monitoring has recently been used for management of chronic obstructive pulmonary disease patients.
Objectives: We analyzed the effect of tele-monitoring on chronic obstructive pulmonary disease patients and performed subgroup analysis by patient severity and intervention type.
Design: Systematic review.
Data Source: Electronic databases including Ovid-Medline, Ovid-Embase, and the Cochrane Library.
Review Methods: We conducted a meta-analysis of randomized controlled trials published up to April 2017. Three databases were searched, two investigators independently extracted data and assessed study quality using risk of bias.
Results: Out of 1,185 studies, 27 articles were identified to be relevant for this study. The included studies were divided by intervention: 15 studies used tele-monitoring only, 4studies used integrated tele-monitoring [pure control], and 8 studies used integrated tele-monitoring [not pure control]. We also divided the studies by patient severity: 16 studies included severely ill patients, 8 studies included moderately ill patients, and 3 studies did not discuss the severity of the patients’ illness. Meta-analysis showed that tele-monitoring reduced the emergency room visits (risk ratio 0.63, 95% confidence interval 0.55-0.72) and hospitalizations (risk ratio 0.88, 95% confidence interval 0.80-0.97). The subgroup analysis of patient severity showed that tele-monitoring more effectively reduced emergency room visits in patients with severe vs. moderate disease (risk ratio 0.48, 95% confidence interval 0.31-0.74; risk ratio 1.28, 95% confidence interval 0.61-2.69, retrospectively) and hospitalizations (risk ratio 0.92, 95% confidence interval 0.82-1.02; risk ratio 1.24, 95% confidence interval 0.57-2.70, retrospectively). The mental health quality of life score (mean difference 3.06, 95% confidence interval 2.15-3.98) showed more improved quality of life than the physical health quality of life score (mean difference -0.11, 95% confidence interval -0.83-0.61).
Conclusions: Tele-monitoring reduced rates of emergency room visits and hospitalizations and improved the mental health quality of life score. Integrated tele-monitoring including the delivery of coping skills or education by online methods including pulmonary rehabilitation is recommended to produce significant improvement. This application of integrated tele-monitoring the delivery of education, exercise and other interventions in addition to tele-monitoring is more useful for patients with severe chronic obstructive pulmonary disease than those with moderate disease. Tele-monitoring might be a useful application of information and communication technologies, if the intervention includes the appropriate intervention components for eligible patients. Further studies such as large size randomized controlled trials with sub-group by patient severity and intervention type is needed to confirm these finding.
Baroi et al (2018) [Systematic Review] Advances in Remote Respiratory Assessments for People With Chronic Obstructive Pulmonary Disease: A Systematic Review
Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality. Advances in remote technologies and telemedicine provide new ways to monitor respiratory function and improve chronic disease management. However, telemedicine does not always include remote respiratory assessments, and the current state of knowledge for people with COPD has not been evaluated.
Objective: Systematically review the use of remote respiratory assessments in people with COPD, including the following questions: What devices have been used? Can acute exacerbations of chronic obstructive pulmonary disease (AECOPD) be predicted by using remote devices? Do remote respiratory assessments improve health-related outcomes?
Materials and Methods: The review protocol was registered (PROSPERO 2016:CRD42016049333). MEDLINE, EMBASE, and COMPENDEX databases were searched for studies that included remote respiratory assessments in people with COPD. A narrative synthesis was then conducted by two reviewers according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Results: Fifteen studies met the inclusion criteria. Forced expiratory volume assessed daily by using a spirometer was the most common modality. Other measurements included resting respiratory rate, respiratory sounds, and end-tidal carbon dioxide level. Remote assessments had high user satisfaction. Benefits included early detection of AECOPD, improved health-related outcomes, and the ability to replace hospital care with a virtual ward.
Conclusion: Remote respiratory assessments are feasible and when combined with sufficient organizational backup can improve health-related outcomes in some but not all cohorts. Future research should focus on the early detection, intervention, and rehabilitation for AECOPD in high-risk people who have limited access to best care and investigate continuous as well as intermittent monitoring.
Buekers et al (2018) [Systematic Review] Oxygen Saturation Measurements in Telemonitoring of Patients With COPD: A Systematic Review
Telemonitoring applications are expected to become a key component in future healthcare. Despite the frequent use of SpO2 measurements in telemonitoring of patients with chronic obstructive pulmonary disease (COPD), no profound overview is available about these measurements. Areas covered: A systematic search identified 71 articles that performed SpO2 measurements in COPD telemonitoring. The results indicate that long-term follow-up of COPD patients using daily SpO2 spot checks is practically feasible. Very few studies specified protocols for performing these measurements. In many studies, deviating SpO2 values were used to raise alerts that led to immediate action from healthcare professionals. However, little information was available about the exact implementation and performance of these alerts. Therefore, no firm conclusions can be drawn about the real value of SpO2 measurements. Future research could optimize performance of alerts using individualized, time-dependent thresholds or predictive algorithms to account for individual differences and SpO2 baseline changes. Additionally, the value of performing continuous measurements should be examined. Expert commentary: Standardization of the measurements, data science techniques and advancing technology can still boost performance of telemonitoring applications. All these opportunities should be thoroughly explored to assess the real value of SpO2 in COPD telemonitoring.
Yang et al (2018) [Systematic Review and Meta-Analysis] Mobile Health Applications in Self-Management of Patients With Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis of Their Efficacy
Background: Mobile health applications are increasingly used in patients with Chronic Obstructive Pulmonary Disease (COPD) to improve their self-management, nonetheless, without firm evidence of their efficacy. This meta-analysis was aimed to assess the efficacy of mobile health applications in supporting self-management as an intervention to reduce hospital admission rates and average days of hospitalization, etc. Methods: PubMed, Web of Science, Cochrane Library, and Embase were searched for relevant articles published before November 14, 2017. A total of 6 reports with randomized controlled trials were finally included in this meta-analysis.
Results: Patients using mobile phone applications may have a lower risk for hospital admissions than those in the usual care group (risk ratio (RR) = 0.73, 95% CI [0.52, 1.04]). However, there was no significant difference in reducing the average days of hospitalization.
Conclusion: Self-management with mobile phone applications could reduce hospital admissions of patients with COPD.
Hanlon et al (2017) [Systematic Review] Telehealth Interventions to Support Self-Management of Long-Term Conditions: A Systematic Metareview of Diabetes, Heart Failure, Asthma, Chronic Obstructive Pulmonary Disease, and Cancer
Background: Self-management support is one mechanism by which telehealth interventions have been proposed to facilitate management of long-term conditions.
Objective: The objectives of this metareview were to: 1. assess the impact of telehealth interventions to support self-management on disease control and health care utilization; and 2. identify components of telehealth support and their impact on disease control and the process of self-management. Our goal was to synthesise evidence for telehealth-supported self-management of diabetes, heart failure, asthma, chronic obstructive pulmonary disease (COPD) and cancer to identify components of effective self-management support.
Methods: We performed a metareview [a systematic review of systematic reviews] of randomized controlled trials of telehealth interventions to support self-management in 6 exemplar long-term conditions. We searched 7 databases for reviews published from January 2000 to May 2016 and screened identified studies against eligibility criteria. We weighted reviews by quality, size, and relevance. We then combined our results in a narrative synthesis and using harvest plots.
Results: We included 53 systematic reviews, comprising 232 unique RCTs. Reviews concerned diabetes (type 1: n=6; type 2, n=11; mixed, n=19), heart failure (n=9), asthma (n=8), COPD (n=8), and cancer (n=3). Findings varied between and within disease areas. The highest-weighted reviews showed that blood glucose telemonitoring with feedback and some educational and lifestyle interventions improved glycemic control in type 2, but not type 1, diabetes, and that telemonitoring and telephone interventions reduced mortality and hospital admissions in heart failure, but these findings were not consistent in all reviews. Results for the other conditions were mixed, although no reviews showed evidence of harm. Analysis of the mediating role of self-management, and of components of successful interventions, was limited and inconclusive. More intensive and multifaceted interventions were associated with greater improvements in diabetes, heart failure, and asthma.
Conclusions: While telehealth-mediated self-management was not consistently superior to usual care, none of the reviews reported any negative effects, suggesting that telehealth is a safe option for delivery of self-management support, particularly in conditions such as heart failure and type 2 diabetes, where the evidence base is more developed. Larger-scale trials of telehealth-supported self-management, based on explicit self-management theory, are needed before the extent to which telehealth technologies may be harnessed to support self-management can be established.
Alwashmi et al (2016) [Systematic Review and Meta-Analysis] The Effect of Smartphone Interventions on Patients With Chronic Obstructive Pulmonary Disease Exacerbations: A Systematic Review and Meta-Analysis
Background: The prevalence and mortality rates of chronic obstructive pulmonary disease (COPD) are increasing worldwide. Therefore, COPD remains a major public health problem. There is a growing interest in the use of smartphone technology for health promotion and disease management interventions. However, the effectiveness of smartphones in reducing the number of patients having a COPD exacerbation is poorly understood.
Objective: To summarize and quantify the association between smartphone interventions and COPD exacerbations through a comprehensive systematic review and meta-analysis.
Methods: A comprehensive search strategy was conducted across relevant databases from inception to October 2015. We included studies that assessed the use of smartphone interventions in the reduction of COPD exacerbations compared with usual care. Full-text studies were excluded if the investigators did not use a smartphone device or did not report on COPD exacerbations. Observational studies, abstracts, and reviews were also excluded. Two reviewers extracted the data and conducted a risk of bias assessment using the US Preventive Services Task Force quality rating criteria. A random effects model was used to meta-analyze the results from included studies. Pooled odds ratios were used to measure the effectiveness of smartphone interventions on COPD exacerbations. Heterogeneity was also measured.
Results: Of the 245 unique citations screened, 6 studies were included in the qualitative synthesis. Studies were relatively small with less than 100 participants in each study (range 30 to 99) and follow-up ranged from 4-9 months. The mean age was 70.5 years (SD 5.6) and 74% (281/380) were male. The studies varied in terms of country, type of smartphone intervention, frequency of data collection from the participants, and the feedback strategy. Three studies were included in the meta-analysis. The overall assessment of potential bias of the studies that were included in the meta-analysis was good for one study and fair for 2 studies. The pooled random effects odds ratio of patients having an exacerbation was 0.20 in patients using a smartphone intervention (95% CI 0.07-0.62), a reduction of 80% for smartphone interventions compared with usual care. However, there was moderate heterogeneity across the included studies.
Conclusion: Although current literature on the role of smartphones in reducing COPD exacerbations is limited, findings from our review suggest that smartphones are useful in reducing the number of patients having a COPD exacerbation. Nevertheless, using smartphones require synergistic strategies to achieve the desired outcome. These results should be interpreted with caution due to the heterogeneity among the studies. Researchers should focus on conducting rigorous studies with adequately powered sample sizes to determine the validity and clinical utility of smartphone interventions in the management of COPD.
Brunton et al (2015) [Systematic Review and Meta-Analysis] The Contradictions of Telehealth User Experience in Chronic Obstructive Pulmonary Disease (COPD): A Qualitative Meta-Synthesis
Objective: As the global burden of chronic disease rises, policy makers are showing a strong interest in adopting telehealth technologies for use in long term condition management, including COPD. However, there remain barriers to its implementation and sustained use. To date, there has been limited qualitative investigation into how users both patients/carers and staff perceive and experience the technology. We aimed to systematically review and synthesise the findings from qualitative studies that investigated user perspectives and experiences of telehealth in COPD management, in order to identify factors which may impact on uptake.
Method: Systematic review and meta-synthesis of published qualitative studies of user experience of telehealth technologies for the management of Chronic Obstructive Pulmonary Disease. ASSIA, CINAHL, Embase, Medline, PsychInfo and Web of Knowledge databases were searched up to October 2014. Reference lists of included studies and reference lists of key papers were also searched. Quality appraisal was guided by an adapted version of the CASP qualitative appraisal tool.
Findings: 705 references were identified and 10 papers, relating to 7 studies were included in the review. Most authors of included studies had identified both positive and negative experiences of telehealth use in the management of COPD. Through a line of argument synthesis we were able to derive new insights from the data to identify three overarching themes that have the ability to either impede or promote positive user experience of telehealth in COPD: the influence on moral dilemmas of help-seeking [enables dependency or self-care]; transforming interactions [increases risk or reassurance]; and reconfiguration of work practices [causes burden or empowerment].
Conclusion: Findings from this meta-synthesis have implications for the future design and implementation of telehealth services. Future research needs to include potential users at an earlier stage of telehealth/service development.
Lundell et al (2015) [Systematic Review and Meta-Analysis] Telehealthcare in COPD: A Systematic Review and Meta-Analysis on Physical Outcomes and Dyspnea
Background: Only a minority of patients with chronic obstructive pulmonary disease (COPD) have access to pulmonary rehabilitation (PR). Home-based solutions such as telehealthcare, have been used in efforts to make PR more available. The aim of this systematic review was to investigate the effects of telehealthcare on physical activity level, physical capacity and dyspnea in patients with COPD, and to describe the interventions used.
Methods: Randomized controlled trials were identified through database searches, reference lists and included authors. Articles were reviewed based on eligibility criteria by three authors. Risk of bias was assessed by two authors. Standardized mean differences (SMD) or mean differences (MD) with 95% CI were calculated. Forest plots were used to present data visually.
Results: Nine studies [982 patients] were included. For physical activity level, there was a significant effect favoring telehealthcare (MD, 64.7 min; 95% CI, 54.4-74.9). No difference between groups was found for physical capacity (MD, -1.3 m; 95% CI, -8.1-5.5) and dyspnea (SMD, 0.088; 95% CI, -0.056-0.233). Telehealthcare was promoted through phone calls, websites or mobile phones, often combined with education and/or exercise training. Comparators were ordinary care, exercise training and/or education.
Conclusions: The use of telehealthcare may lead to improvements in physical activity level, although the results should be interpreted with caution given the heterogeneity in studies. This is an important area of research and further studies of the effect of telehealthcare for patients with COPD would be beneficial.
Pedone and Lelli (2015) [Systematic Review] Systematic Review of Telemonitoring in COPD: An Update
Telemedicine may support individual care plans in people with chronic obstructive pulmonary disease (COPD), potentially improving the clinical outcomes. To-date there is no clear evidence of benefit of telemedicine in this patients. The aim of this study is to provide an update on the effectiveness of telemedicine in reducing adverse clinical outcomes. We searched the Pubmed database for articles published between January 2005 and December 2014. We included only randomized controlled trials exclusively focused on patients with COPD and with a telemedicine intervention arm. Evaluated outcomes were number of exacerbations, ER visits, COPD hospitalizations, length of stay and death. We eventually included 12 randomized controlled trials. Most of them had a small sample size and was of poor quality, with a wide heterogeneity in the parameters and technologies used. Most studies reported a positive effect of telemonitoring on hospitalization for any cause, with risk reductions between 10% and 63%; however only three studies reached statistical significance. The same trend was observed for COPD-related hospital admission and ER visits. No significative effects of telemedicine was evidenced in reducing length of hospital stay, improving quality of life and reducing deaths. In conclusion, our study confirms that the available evidence on the effectiveness of telemedicine in COPD does not allow to draw definite conclusions; most evidence suggests a positive effect of telemonitoring on hospital admissions and ER visits. More trials with adequate sample size and with adequate consideration of background clinical services are needed to definitively establish its effectiveness.
Randomised Controlled Trials
Duiverman et al (2020) [Randomised Controlled Trial] Home Initiation of Chronic Non-Invasive Ventilation in COPD Patients With Chronic Hypercapnic Respiratory Failure: A Randomised Controlled Trial
Introduction: Chronic non-invasive ventilation (NIV) has become evidence-based care for stable hypercapnic COPD patients. While the number of patients increases, home initiation of NIV would greatly alleviate the healthcare burden. We hypothesise that home initiation of NIV with the use of telemedicine in stable hypercapnic COPD is non-inferior to in-hospital NIV initiation.
Methods: Sixty-seven stable hypercapnic COPD patients were randomised to initiation of NIV in the hospital or at home using telemedicine. Primary outcome was daytime arterial carbon dioxide pressure (PaCO2) reduction after 6 months NIV, with a non-inferiority margin of 0.4 kPa. Secondary outcomes were health-related quality of life (HRQoL) and costs.
Results: Home NIV initiation was non-inferior to in-hospital initiation (adjusted mean difference in PaCO2 change home vs in-hospital: 0.04 kPa (95% CI -0.31 to 0.38 kPa), with both groups showing a PaCO2 reduction at 6 months compared with baseline (home: from 7.3±0.9 to 6.4±0.8 kPa (p<0.001) and in-hospital: from 7.4±1.0 to 6.4±0.6 kPa (p<0.001)). In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI -0.4 to 0.5)). Furthermore, home NIV initiation was significantly cheaper (home: median €3768 (IQR €3546-€4163) vs in-hospital: median €8537 (IQR €7540-€9175); p<0.001).
Discussion: This is the first study showing that home initiation of chronic NIV in stable hypercapnic COPD patients, with the use of telemedicine, is non-inferior to in-hospital initiation, safe and reduces costs by over 50%.
Galdiz et al (2020) [Randomised Controlled Trial] Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial
Background: There is uncertainty regarding efficacy of telehealth-based approaches in COPD patients for sustaining benefits achieved with intensive pulmonary rehabilitation (PR).
Research Question: To determine whether a maintenance pulmonary telerehabilitation (TelePR) programme, after intensive initial PR, is superior to usual care in sustaining over time benefits achieved by intensive PR.
Study Design and Methods: A multicentre open-label pragmatic parallel-group randomized clinical trial was conducted. Two groups were created at completion of an 8-week intensive outpatient hospital PR programme. Intervention group (IG) patients were given appropriate training equipment and instructed to perform three weekly training sessions and send performance data through an app to a web-based platform. Patients in the control group (CG) were advised to exercise regularly [usual care].
Results: Ninety-four patients (46 IG, 48 CG) were randomized. The analysis of covariance showed non-significant improvements in 6-min walk distance [19.9m (95% CI -4.1/+43.8)] and Chronic Respiratory Disease Questionnaire – Emotion score [0.4 points (0-0.8)] in the IG. Secondary linear mixed models showed improvements in the IG in Short Form-36 mental component summary [9.7, (4.0-15.4)] and Chronic Respiratory Disease Questionnaire – Emotion [0.5, (0.2-0.9)] scores, but there was no association between compliance and outcomes. Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (-32.3/0.8) in linear models.
Conclusions: The TelePR maintenance strategy was both feasible and safe but failed to show superiority over usual care, despite improvements in some HRQoL domains. Acute exacerbations may have an important negative influence on long-term physical function.
Jiang et al (2020) [Randomised Controlled Trial] Evaluating an Intervention Program Using WeChat for Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial
Background: The application of telemedicine in home pulmonary rehabilitation interventions for the management of patients with chronic obstructive pulmonary disease (COPD) has achieved promising results.
Objective: This study aimed to develop a WeChat official account (Pulmonary Internet Explorer Rehabilitation [PeR]) based on social media. It further evaluated the effect of PeR on the quality of life, symptoms, and exercise self-efficacy of patients with COPD.
Methods: The functional modules of PeR were developed by a multidisciplinary team according to the electronic health-enhanced chronic care model (eCCM) components. A total of 106 patients were randomly selected (53 in the PeR group and 53 in the outpatient face-to-face group [FtF]). Pulmonary rehabilitation intervention was conducted for 3 months, and the outcome was observed for 3 months. The primary outcome was patient quality of life measured with the COPD assessment test (CAT). The secondary outcomes were evaluated using the modified Medical Research Council scale (mMRC), exercise self-regulatory efficacy scale (Ex-SRES), and St George’s Respiratory Questionnaire (SGRQ).
Results: The intention-to-treat analysis was used in the study. A total of 94 participants completed the 6-month pulmonary rehabilitation program. No statistically significant differences were observed in CAT (F1,3=7.78, P=.001), Ex-SRES (F1,3=21.91, P<.001), and mMRC scores (F1,3=29.64, P<.001) between the two groups with the variation in time tendency. The Ex-SRES score had a significant effect on the CAT score (P=.03). The partial regression coefficient of Ex-SRES to CAT was 0.81, and Exp (B) was 2.24.
Conclusions: The telemedicine technology was effective using the eCCM combined with a behavioral intervention strategy centering on self-efficacy. Pulmonary rehabilitation at home through PeR and FtF could improve the sense of self-efficacy and quality of life and alleviate symptoms in patients with COPD.
Jimenez-Reguera et al (2020) [Randomised Controlled Trial] Development And Preliminary Evaluation Of The Effects Of An mHealth Web-based Platform (HappyAir™) on Adherence To a Maintenance Program After Pulmonary Rehabilitation In COPD Patients: Randomized Controlled Trial
Background: Pulmonary rehabilitation (PR) is one of the main interventions to reduce the use of health resources, and it promotes a reduction in chronic obstructive pulmonary disease (COPD) costs. mHealth systems in COPD aim to improve adherence to maintenance programs after PR by promoting the change in attitude and behavior necessary for patient involvement in the management of the disease.
Objective: This study aimed to assess the effects of an integrated care plan based on an mHealth web-based platform [HappyAir™] on adherence to a 1-year maintenance program applied after PR in COPD patients.
Methods: COPD patients from three hospitals were randomized to a control group (CG) or an intervention group [HappyAir™ group [HG]]. Patients from both groups received an 8-week program of PR and educational sessions about their illness. After completion of the process, only the HG performed an integrated care plan for 10 months, supervised by an mHealth system and therapeutic educator. The CG only underwent the scheduled check-ups. Adherence to the program was rated using the CAP FISIO questionnaire. Other variables analyzed were adherence to physical activity (Morisky-Green Test), quality of life (CAT, SGRQ and EuroQOL-5D), exercise capacity (6MWT) and lung function.
Results: In total, 44 patients were recruited and randomized in the CG (n=24) and HG (n=20). Eight patients dropped out for different reasons. The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HG, which was statistically different compared to the CG at 12 months (56.1±4 vs 44±13.6; P=.004) after PR.
Conclusions: mHealth systems designed for COPD patients improve adherence to maintenance programs, as long as they are accompanied by disease awareness and patient involvement in management.
Sink et al (2020) [Randomised Controlled Trial] Effectiveness of a Novel, Automated Telephone Intervention on Time to Hospitalisation in Patients With COPD: A Randomised Controlled Trial
Introduction: Owing to its capacity to perform remote assessments, telemedicine is rising as a new force in chronic obstructive pulmonary disease (COPD) management. We conducted an eight month randomised-controlled-trial to study the effect of an automated telemedicine intervention on patients’ time-to-hospitalisation.
Methods: A total of 168 patients with a diagnosis of COPD in the past 24 months were enrolled to receive the intervention at a primary care clinic. The treatment group received daily phone messages from an automated system asking them to report if they were breathing better than, worse than, or the same as the day prior. Patients reported their breathing status by responding to the text message or call. If a patient reported breathing worse, an alert was sent directly to that patient’s provider within the clinic. The control group received the same daily phone messages as the treatment group. However, no proactive breathing alerts were ever generated to the provider for these subjects. The primary outcome was the subjects’ time-to-first-COPD-related hospitalisation following the start of messages.
Results: The treatment group’s time-to-hospitalisation was significantly different than the control group’s with a hazard ratio of 2.36 (95% confidence interval 1.02–5.45, p = 0.0443). The number needed-to-treat ratio was 8.62. Subject engagement consistently ranged between 60% and 75%. The treatment group received both proactive monitoring and follow-up care from the providers.
Discussion: Active monitoring with provider feedback enables the detection of exacerbation events early enough for subjects to avoid admissions. The use of non-smartphone interventions reduces barriers to care presented by more complicated and expensive technologies. This intervention represents a simple, innovative, and inexpensive tool for improved COPD management.
Boer et al (2019) [Randomised Controlled Trial] A Smart Mobile Health Tool Versus a Paper Action Plan to Support Self-Management of Chronic Obstructive Pulmonary Disease Exacerbations: Randomized Controlled Trial
Background: Many patients with chronic obstructive pulmonary disease (COPD) suffer from exacerbations, a worsening of their respiratory symptoms that warrants medical treatment. Exacerbations are often poorly recognized or managed by patients, leading to increased disease burden and health care costs.
Objective: This study aimed to examine the effects of a smart mobile health (mHealth) tool that supports COPD patients in the self-management of exacerbations by providing predictions of early exacerbation onset and timely treatment advice without the interference of health care professionals.
Methods: In a multicenter, 2-arm randomized controlled trial with 12-months follow-up, patients with COPD used the smart mHealth tool [intervention group] or a paper action plan [control group] when they experienced worsening of respiratory symptoms. For our primary outcome exacerbation-free time, expressed as weeks without exacerbation, we used an automated telephone questionnaire system to measure weekly respiratory symptoms and treatment actions. Secondary outcomes were health status, self-efficacy, self-management behavior, health care utilization, and usability. For our analyses, we used negative binomial regression, multilevel logistic regression, and generalized estimating equation regression models.
Results: Of the 87 patients with COPD recruited from primary and secondary care centers, 43 were randomized to the intervention group. We found no statistically significant differences between the intervention group and the control group in exacerbation-free weeks (mean 30.6, SD 13.3 vs mean 28.0, SD 14.8 weeks, respectively; rate ratio 1.21; 95% CI 0.77-1.91) or in health status, self-efficacy, self-management behavior, and health care utilization. Patients using the mHealth tool valued it as a more supportive tool than patients using the paper action plan. Patients considered the usability of the mHealth tool as good.
Conclusions: This study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan. Participants were positive about the supportive function and the usability of the mHealth tool. mHealth may be a valuable alternative for COPD patients who prefer a digital tool instead of a paper action plan.
Ancochea et al (2018) [Randomised Controlled Trial] Efficacy and Costs of Telehealth for the Management of COPD: The PROMETE II Trial
Chronic obstructive pulmonary disease (COPD) is a significant and largely underdiagnosed cause of morbidity and mortality worldwide. More long-term survivors with advanced disease have led to an ageing COPD population profile with an increased level of acute exacerbations, hospitalisations and polymorbidity.
Attention has been placed on identifying and validating innovative COPD care models, such as telehealth, particularly for high-cost patients with severe COPD and/or frequent acute exacerbations. Early intervention during an exacerbation has been shown to reduce severity, duration and hospitalisation rates, and may lead to a slower decline in lung function and reduced clinical or social care costs.
Remote patient monitoring is often a key element of new care programmes as it permits the regular collection of physiological and symptomatic data from patients at home, which can be used to promptly identify exacerbations and initiate treatment.
Previously, the PROMETE I study confirmed the practicality of a telehealth intervention for severe COPD patients, and produced directional cost and clinical benefit data. As a development and refinement of this study, the larger and longer PROMETE II project was designed. The primary objective was to reduce the number of COPD exacerbations leading to emergency department visits/hospital admissions with telehealth.
Broadbent et al (2018) [Randomised Controlled Trial] Using Robots at Home to Support Patients With Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial
Background: Socially assistive robots are being developed for patients to help manage chronic health conditions such as chronic obstructive pulmonary disease (COPD). Adherence to medication and availability of rehabilitation are suboptimal in this patient group, which increases the risk of hospitalization.
Objective: This pilot study aimed to investigate the effectiveness of a robot delivering telehealth care to increase adherence to medication and home rehabilitation, improve quality of life, and reduce hospital readmission compared with a standard care control group.
Methods: At discharge from hospital for a COPD admission, 60 patients were randomized to receive a robot at home for 4 months or to a control group. Number of hospitalization days for respiratory admissions over the 4-month study period was the primary outcome. Medication adherence, frequency of rehabilitation exercise, and quality of life were also assessed. Implementation interviews as well as benefit-cost analysis were conducted.
Results: Intention-to-treat and per protocol analyses showed no significant differences in the number of respiratory-related hospitalizations between groups. The intervention group was more adherent to their long-acting inhalers (mean number of prescribed puffs taken per day=48.5%) than the control group (mean 29.5%, P=.03, d=0.68) assessed via electronic recording. Self-reported adherence was also higher in the intervention group after controlling for covariates (P=.04). The intervention group increased their rehabilitation exercise frequency compared with the control group (mean difference -4.53, 95% CI -7.16 to -1.92). There were no significant differences in quality of life. Of the 25 patients who had the robot, 19 had favorable attitudes.
Conclusions: This pilot study suggests that a homecare robot can improve adherence to medication and increase exercise. Further research is needed with a larger sample size to further investigate effects on hospitalizations after improvements are made to the robots. The robots could be especially useful for patients struggling with adherence.
Kwon et al (2018) [Randomised Controlled Trial] An mHealth Management Platform for Patients With Chronic Obstructive Pulmonary Disease (Efil Breath): Randomized Controlled Trial
Background: Chronic obstructive pulmonary disease (COPD) is one of the major morbidities in public health, and the use of mHealth technology for rehabilitation of patients with COPD can help increase physical activity and ameliorate respiratory symptoms.
Objective: This study aimed to develop a comprehensive rehabilitation management platform to improve physical activity and quality of life in patients with COPD.
Methods: The study comprised the following 2 stages: 1. a pilot stage in which a prototype app was developed; and 2. a fully-fledged platform development stage in which 2 apps and 1 COPD patient monitoring website were developed. We conducted a randomized clinical trial to investigate the efficacy of the apps developed in the second stage of the study. In addition, two 12-week exercise regimens [fixed and fixed-interactive] were tested for the trial. The clinical parameters of the respiratory function and patient global assessment (PGA) of the app were obtained and analyzed. Notably, Android was the chosen operating system for apps.
Results: We developed 2 COPD rehabilitation apps and 1 patient monitoring website. For the clinical trial, 85 patients were randomized into the following 3 groups: 57 were allocated to the 2 intervention groups and 28 to the control group. After 6 weeks, the COPD assessment test scores were significantly reduced in the fixed group (P=.01), and signs of improvement were witnessed in the fixed-interactive group. In addition, the PGA score was moderate or high in all aspects of the user experience of the apps in both intervention groups.
Conclusions: A well-designed mobile rehabilitation app for monitoring and managing patients with COPD can supplement or replace traditional center-based rehabilitation programs and achieve improved patient health outcomes.
Soriano et al (2018) [Randomised Controlled Trial] A Multicentre, Randomized Controlled Trial of Telehealth for the Management of COPD
Background: Evidence is needed to determine the role of telehealth (TH) in COPD management.
Methods: PROMETE II was a multicentre, randomized, 12-month trial. Severe COPD patients in stable condition were randomized to a specific monitoring protocol with TH or routine clinical practice (RCP). The primary objective was to reduce the number of COPD exacerbations leading to ER visits/hospital admissions between groups.
Results: Overall, 237 COPD patients were screened, and 229 (96.6%) were randomized to TH (n = 115) or RCP (n = 114), with age of 71 ± 8 years and 80% were men. Overall, 169 completed the full follow-up period. There were no statistical differences at one year between groups in the proportion of participants who had a COPD exacerbation (60% in TH vs. 53.5% in RCP; p = 0.321). There was, however, a marked but non-significant trend towards a shorter duration of hospitalization and days in ICU in the TH group (18.9 ± 16.0 and 6.0 ± 4.6 days) compared to the RCP group (22.4 ± 19.5 and 13.3 ± 11.1 days). The number of all-cause deaths was comparable between groups (12 in TH vs. 13 in RCP) as was total resource utilization cost (7912€ in TH vs. 8918€ in RCP). Telehealth was evaluated highly positively by patients and doctors.
Conclusions: Remote patient management did not reduce COPD-related ER visits or hospital admissions compared to RCP within 12 months.
Tupper et al (2018) [Randomised Controlled Trial] Effect of Tele-Health Care on Quality of Life in Patients With Severe COPD: A Randomized Clinical Trial
Background and Objective: Telemonitoring (TM) of patients with COPD has gained much interest, but studies have produced conflicting results. We aimed to investigate the effect of TM with the option of video consultations on quality of life (QoL) in patients with severe COPD.
Patients and Methods: COPD patients at high risk of exacerbations were eligible for the 6-month study and a total of 281 patients were equally randomized to either TM (n=141) or usual care (n=140). TM comprised recording of symptoms, oxygen saturation, spirometry, and video consultations. Algorithms generated alerts if readings breached thresholds. Both groups filled in a health-related QoL questionnaire (15D©) and the COPD Assessment Test (CAT) at baseline and at 6 months. Within-group differences were analyzed by paired t-test.
Results: Most of the enrolled patients had severe COPD: 86% with Global Initiative for Chronic Obstructive Lung Disease stage 3 or 4 and 45% with admission for COPD within the last year, respectively. No difference in drop-out rate and mortality was found between the groups, and likewise there was no difference in 15D or CAT at baseline. At 6 months, a significant improvement of 0.016 in 15D score (p=0.03; minimal clinically important difference 0.015) was observed in the TM group compared to baseline, while there was no improvement in the control group -0.003 (p=0.68). After stratifying 15D score at baseline to <0.75 or ≥0.75, respectively, there was a significant difference in the <0.75 TM group of 0.037 (p=0.001), which is a substantial improvement. No statistically significant changes were found in CAT score.
Conclusion: Compared to the nonintervention group, TM as an add-on to usual care over a 6-month period improved QoL, as assessed by the 15D questionnaire, in patients with severe COPD, whereas no difference between groups was observed in CAT score.
Walker et al (2018) [Randomised Controlled Trial] Telemonitoring in Chronic Obstructive Pulmonary Disease (CHROMED). A Randomized Clinical Trial
Rationale: Early detection of chronic obstructive pulmonary disease (COPD) exacerbations using telemonitoring of physiological variables might reduce the frequency of hospitalization.
Objectives: To evaluate the efficacy of home monitoring of lung mechanics by the forced oscillation technique and cardiac parameters in older patients with COPD and comorbidities.
Methods: This multicenter, randomized clinical trial recruited 312 patients with Global Initiative for Chronic Obstructive Lung Disease grades II to IV COPD (median age, 71 yr [interquartile range, 66-76 yr]; 49.6% grade II, 50.4% grades III-IV), with a history of exacerbation in the previous year and at least one nonpulmonary comorbidity. Patients were randomized to usual care (n = 158) or telemonitoring (n = 154) and followed for 9 months. All telemonitoring patients self-assessed lung mechanics daily, and in a subgroup with congestive heart failure (n = 37) cardiac parameters were also monitored. An algorithm identified deterioration, triggering a telephone contact to determine appropriate interventions.
Measurements and Main Results: Primary outcomes were time to first hospitalization (TTFH) and change in the EuroQoL EQ-5D utility index score. Secondary outcomes included: rate of antibiotic/corticosteroid prescription; hospitalization; the COPD Assessment Tool, Patient Health Questionnaire-9, and Minnesota Living with Heart Failure questionnaire scores; quality-adjusted life years; and healthcare costs. Telemonitoring did not affect TTFH, EQ-5D utility index score, antibiotic prescriptions, hospitalization rate, or questionnaire scores. In an exploratory analysis, telemedicine was associated with fewer repeat hospitalizations (-54%; P = 0.017).
Conclusions: In older patients with COPD and comorbidities, remote monitoring of lung function by forced oscillation technique and cardiac parameters did not change TTFH and EQ-5D.
Bourne et al (2017) [Randomised Controlled Trial] Online Versus Face-To-Face Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease: Randomised Controlled Trial
Objective: To obtain evidence whether the online pulmonary rehabilitation(PR) programme ‘my-PR’ is non-inferior to a conventional face-to-face PR in improving physical performance and symptom scores in patients with COPD.
Design: A two-arm parallel single-blind, randomised controlled trial.
Setting: The online arm carried out pulmonary rehabilitation in their own homes and the face to face arm in a local rehabilitation facility.
Participants: 90 patients with a diagnosis of chronic obstructive pulmonary disease (COPD), modified Medical Research Council score of 2 or greater referred for pulmonary rehabilitation (PR), randomised in a 2:1 ratio to online (n=64) or face-to-face PR (n=26). Participants unable to use an internet-enabled device at home were excluded.
Main Outcome Measures: Coprimary outcomes were 6 min walk distance test and the COPD assessment test (CAT) score at completion of the programme.
Interventions: A 6-week PR programme organised either as group sessions in a local rehabilitation facility, or online PR via log in and access to ‘myPR’.
Results: The adjusted mean difference for the 6 min walk test (6MWT) between groups for the intention-to-treat (ITT) population was 23.8 m with the lower 95% CI well above the non-inferiority threshold of -40.5 m at -4.5 m with an upper 95% CI of +52.2 m. This result was consistent in the per-protocol (PP) population with a mean adjusted difference of 15 m (-13.7 to 43.8). The CAT score difference in the ITT was -1.0 in favour of the online intervention with the upper 95% CI well below the non-inferiority threshold of 1.8 at 0.86 and the lower 95% CI of -2.9. The PP analysis was consistent with the ITT.
Conclusion: PR is an evidenced-based and guideline-mandated intervention for patients with COPD with functional limitation. A 6-week programme of online-supported PR was non-inferior to a conventional model delivered in face-to-face sessions in terms of effects on 6MWT distance, and symptom scores and was safe and well tolerated.
Chaplin et al (2017) [Randomised Controlled Trial] Interactive Web-Based Pulmonary Rehabilitation Programme: A Randomised Controlled Feasibility Trial
Objectives: The aim of this study was to determine if an interactive web-based pulmonary rehabilitation (PR) programme is a feasible alternative to conventional PR.
Design: Randomised controlled feasibility trial.
Setting: Participants with a diagnosis of chronic obstructive pulmonary disease were recruited from PR assessments, primary care and community rehabilitation programmes. Patients randomised to conventional rehabilitation started the programme according to the standard care at their referred site on the next available date.
Participants: 103 patients were recruited to the study and randomised: 52 to conventional rehabilitation (mean (±SD) age 66 (±8) years, Medical Research Council (MRC) 3 (IQR2-4)); 51 to the web arm (mean (±SD) age 66 (±10) years, MRC 3 (IQR2-4)). Participants had to be willing to participate in either arm of the trial, have internet access and be web literate.
Interventions: Patients randomised to the web-based programme worked through the website, exercising and recording their progress as well as reading educational material. Conventional PR consisted of twice weekly, 2 hourly sessions, an hour for exercise training and an hour for education.
Outcome Measures: Recruitment rates, eligibility, patient preference and dropout and completion rates for both programmes were collected. Standard outcomes for a PR assessment including measures of exercise capacity and quality of life questionnaires were also evaluated.
Results: A statistically significant improvement (p≤0.01) was observed within each group in the endurance shuttle walk test (WEB: mean change 189±211.1; PR classes: mean change 184.5±247.4 s) and Chronic Respiratory disease Questionnaire-Dyspnoea (CRQ-D; WEB: mean change 0.7±1.2; PR classes: mean change 0.8±1.0). However, there were no significant differences between the groups in any outcome. Dropout rates were higher in the web-based programme (57% vs 23%).
Conclusions: An interactive web-based PR programme is feasible and acceptable when compared with conventional PR. Future trials maybe around choice-based PR programmes for select patients enabling stratification of patient care.
Farmer et al (2017) [Randomised Controlled Trial] Self-Management Support Using a Digital Health System Compared With Usual Care for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial
Background: We conducted a randomized controlled trial of a digital health system supporting clinical care through monitoring and self-management support in community-based patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
Objective: The aim of this study was to determine the efficacy of a fully automated Internet-linked, tablet computer-based system of monitoring and self-management support (EDGE’ sElf-management anD support proGrammE) in improving quality of life and clinical outcomes.
Methods: We compared daily use of EDGE with usual care for 12 months. The primary outcome was COPD-specific health status measured with the St George’s Respiratory Questionnaire for COPD (SGRQ-C).
Results: A total of 166 patients were randomized: 110 EDGE vs. 56 usual care. All patients were included in an intention to treat analysis. The estimated difference in SGRQ-C at 12 months was -1.7 with a 95% CI of -6.6 to 3.2 (p=.49). The relative risk of hospital admission for EDGE was 0.83 (0.56-1.24, p=.37) compared with usual care. Generic health status (EQ-5D, EuroQol 5-Dimension Questionnaire) between the groups differed significantly with better health status for the EDGE group (0.076, 95% CI 0.008-0.14, P=.03). The median number of visits to general practitioners for EDGE versus usual care were 4 versus 5.5 (p=.06) and to practice nurses were 1.5 versus 2.5 (p=.03), respectively.
Conclusions: The EDGE clinical trial does not provide evidence for an effect on COPD-specific health status in comparison with usual care, despite uptake of the intervention. However, there appears to be an overall benefit in generic health status; and the effect sizes for improved depression score, reductions in hospital admissions, and general practice visits warrants further evaluation and could make an important contribution to supporting people with COPD.
Rixon et al (2017) [Randomised Controlled Trial] A RCT of Telehealth for COPD Patient’s Quality of Life: The Whole System Demonstrator Evaluation
Introduction and Objectives: Despite some concerns that the introduction of telehealth (TH) may lead to reductions in quality of life (QoL), lower mood and increased anxiety in response to using assistive technologies to reduce health care utilisation and manage long term conditions, this research focuses on the extent to which providing people with tools to monitor their condition can improve QoL.
Methods: The Chronic Obstructive Pulmonary Disease (COPD) cohort of the Whole Systems Demonstrator Trial is a pragmatic General Practitioner (GP) clustered randomised controlled trial (RCT) evaluating TH in the UK from three regions in England. All patients at a participating GP practice were deemed eligible for inclusion in the study if they were diagnosed with COPD.
Results: 447 participants completed baseline and either a short [4 months] or long term [12 months] follow-up. There was a trend of improved QoL and mood in the TH group at longer-term follow-up, but not short term follow-up. Emotional functioning (g = 0.280 95%CI, 0.051-0.510) and mastery reached (g = 2.979 95%CI, 0-0.46) significance at P < 0.05 [all Hedges g <0.3].
Conclusions: TH showed minimal benefit to QoL in COPD patients who were not preselected to be at increased risk of acute exacerbations. Benefits were more likely in disease specific measures at longer term follow-up. TH is a complex intervention and should be embedded in a service that is evidenced based. Outcome measures must be sensitive enough to detect changes in the target population for the specific intervention.
Shah et al (2017) [Randomised Controlled Trial] Exacerbations in Chronic Obstructive Pulmonary Disease: Identification and Prediction Using a Digital Health System
Background: Chronic obstructive pulmonary disease (COPD) is a progressive, chronic respiratory disease with a significant socioeconomic burden. Exacerbations, the sudden and sustained worsening of symptoms, can lead to hospitalization and reduce quality of life. Major limitations of previous telemonitoring interventions for COPD include low compliance, lack of consensus on what constitutes an exacerbation, limited numbers of patients, and short monitoring periods. We developed a telemonitoring system based on a digital health platform that was used to collect data from the 1-year EDGE [Self-Management and Support Programme] COPD clinical trial aiming at daily monitoring in a heterogeneous group of patients with moderate to severe COPD.
Objective: The objectives of the study were as follows: first, to develop a systematic and reproducible approach to exacerbation identification and to track the progression of patient condition during remote monitoring; and second, to develop a robust algorithm able to predict COPD exacerbation, based on vital signs acquired from a pulse oximeter.
Methods: We used data from 110 patients, with a combined monitoring period of more than 35,000 days. We propose a finite-state machine-based approach for modeling COPD exacerbation to gain a deeper insight into COPD patient condition during home monitoring to take account of the time course of symptoms. A robust algorithm based on short-period trend analysis and logistic regression using vital signs derived from a pulse oximeter is also developed to predict exacerbations.
Results: On the basis of 27,260 sessions recorded during the clinical trial with average usage of 5.3 times per week for 12 months, there were 361 exacerbation events. There was considerable variation in the length of exacerbation events, with a mean length of 8.8 days. The mean value of oxygen saturation was lower, and both the pulse rate and respiratory rate were higher before an impending exacerbation episode, compared with stable periods. On the basis of the classifier developed in this work, prediction of COPD exacerbation episodes with 60%-80% sensitivity will result in 68%-36% specificity.
Conclusions: All 3 vital signs acquired from a pulse oximeter pulse rate, oxygen saturation, and respiratory rate are predictive of COPD exacerbation events, with oxygen saturation being the most predictive, followed by respiratory rate and pulse rate. Combination of these vital signs with a robust algorithm based on machine learning leads to further improvement in positive predictive accuracy.
Tsai et al (2017) [Randomised Controlled Trial] Home-based Telerehabilitation via Real-Time Videoconferencing Improves Endurance Exercise Capacity in Patients With COPD: The Randomized Controlled TeleR Study
Background and Objective: Telerehabilitation has the potential to increase access to pulmonary rehabilitation (PR) for patients with COPD who have difficulty accessing centre-based PR due to poor mobility, lack of transport and cost of travel. We aimed to determine the effect of supervised, home-based, real-time videoconferencing telerehabilitation on exercise capacity, self-efficacy, health-related quality of life (HRQoL) and physical activity in patients with COPD compared with usual care without exercise training.
Methods: Patients with COPD were randomized to either a supervised home-based telerehabilitation group (TG) that received exercise training three times a week for 8 weeks or a control group (CG) that received usual care without exercise training. Outcomes were measured at baseline and following the intervention.
Results: Thirty-six out of 37 participants (mean ± SD age = 74 ± 8 years, forced expiratory volume in 1 s (FEV1 ) = 64 ± 21% predicted) completed the study. Compared with the CG, the TG showed a statistically significant increase in endurance shuttle walk test time (mean difference = 340 s (95% CI: 153-526, P < 0.001)), an increase in self-efficacy (mean difference = 8 points (95% CI: 2-14, P < 0.007)), a trend towards a statistically significant increase in the Chronic Respiratory Disease Questionnaire total score (mean difference = 8 points (95% CI: -1 to 16, P = 0.07)) and no difference in physical activity (mean difference = 475 steps per day (95% CI: -200 to 1151, P = 0.16)).
Conclusion: This study showed that telerehabilitation improved endurance exercise capacity and self-efficacy in patients with COPD when compared with usual care.
Vasilopoulou et al (2017) [Randomised Controlled Trial] Home-based Maintenance Tele-Rehabilitation Reduces the Risk for Acute Exacerbations of COPD, Hospitalisations and Emergency Department Visits
Pulmonary rehabilitation (PR) remains grossly underutilised by suitable patients worldwide. We investigated whether home-based maintenance tele-rehabilitation will be as effective as hospital-based maintenance rehabilitation and superior to usual care in reducing the risk for acute chronic obstructive pulmonary disease (COPD) exacerbations, hospitalisations and emergency department (ED) visits. Following completion of an initial 2-month PR programme this prospective, randomised controlled trial between December 2013 and July 2015 compared 12 months of home-based maintenance tele-rehabilitation (n=47) with 12 months of hospital-based, outpatient, maintenance rehabilitation (n=50) and also to 12 months of usual care treatment (n=50) without initial PR. In a multivariate analysis during the 12-month follow-up, both home-based tele-rehabilitation and hospital-based PR remained independent predictors of a lower risk for 1) acute COPD exacerbation (incidence rate ratio (IRR) 0.517, 95% CI 0.389-0.687, and IRR 0.635, 95% CI 0.473-0.853), respectively, and 2) hospitalisations for acute COPD exacerbation (IRR 0.189, 95% CI 0.100-0.358, and IRR 0.375, 95% CI 0.207-0.681), respectively. However, only home-based maintenance tele-rehabilitation and not hospital-based, outpatient, maintenance PR was an independent predictor of ED visits (IRR 0.116, 95% CI 0.072-0.185). Home-based maintenance tele-rehabilitation is equally effective as hospital-based, outpatient, maintenance PR in reducing the risk for acute COPD exacerbation and hospitalisations. In addition, it encounters a lower risk for ED visits, thereby constituting a potentially effective alternative strategy to hospital-based, outpatient, maintenance PR.
Velardo et al (2017) [Randomised Controlled Trial] Digital Health System for Personalised COPD Long-Term Management
Background: Recent telehealth studies have demonstrated minor impact on patients affected by long-term conditions. The use of technology does not guarantee the compliance required for sustained collection of high-quality symptom and physiological data. Remote monitoring alone is not sufficient for successful disease management. A patient-centred design approach is needed in order to allow the personalisation of interventions and encourage the completion of daily self-management tasks.
Methods: A digital health system was designed to support patients suffering from chronic obstructive pulmonary disease in self-managing their condition. The system includes a mobile application running on a consumer tablet personal computer and a secure backend server accessible to the health professionals in charge of patient management. The patient daily routine included the completion of an adaptive, electronic symptom diary on the tablet, and the measurement of oxygen saturation via a wireless pulse oximeter.
Results: The design of the system was based on a patient-centred design approach, informed by patient workshops. One hundred and ten patients in the intervention arm of a randomised controlled trial were subsequently given the tablet computer and pulse oximeter for a 12-month period. Patients were encouraged, but not mandated, to use the digital health system daily. The average used was 6.0 times a week by all those who participated in the full trial. Three months after enrolment, patients were able to complete their symptom diary and oxygen saturation measurement in less than 1 m 40s [96% of symptom diaries]. Custom algorithms, based on the self-monitoring data collected during the first 50 days of use, were developed to personalise alert thresholds.
Conclusions: Strategies and tools aimed at refining a digital health intervention require iterative use to enable convergence on an optimal, usable design. Continuous improvement allowed feedback from users to have an immediate impact on the design of the system such as collection of quality data resulting in high compliance with self-monitoring over a prolonged period of time. Health professionals were prompted by prioritisation algorithms to review patient data, which led to their regular use of the remote monitoring website throughout the trial.
Cameron-Tucker et al (2016) [Randomised Controlled Trial] A Randomized Controlled Trial of Telephone-Mentoring With Home-Based Walking Preceding Rehabilitation in COPD
Purpose: With the limited reach of pulmonary rehabilitation (PR) and low levels of daily physical activity in chronic obstructive pulmonary disease (COPD), a need exists to increase daily exercise. This study evaluated telephone health-mentoring targeting home-based walking [tele-rehabilitation] compared to usual waiting time [usual care] followed by group PR.
Patients and Methods: People with COPD were randomized to tele-rehab [intervention] or usual care [controls]. Tele-rehab delivered by trained nurse health-mentors supported participants’ home-based walking over 8-12 weeks. PR, delivered to both groups simultaneously, included 8 weeks of once-weekly education and self-management skills, with separate supervised exercise. Data were collected at three time-points: baseline (TP1), before (TP2), and after (TP3) pulmonary rehabilitation. The primary outcome was change in physical capacity measured by 6-minute walk distance (6MWD) with two tests performed at each time-point. Secondary outcomes included changes in self-reported home-based walking, health-related quality of life, and health behaviors.
Results: Of 65 recruits, 25 withdrew before completing PR. Forty attended a median of 6 (4) education sessions. Seventeen attended supervised exercise (5±2 sessions). Between TP1 and TP2, there was a statistically significant increase in the median 6MWD of 12 (39.1) m in controls, but no change in the tele-rehab group. There were no significant changes in 6MWD between other time-points or groups, or significant change in any secondary outcomes. Participants attending supervised exercise showed a nonsignificant improvement in 6MWD, 12.3 (71) m, while others showed no change, 0 (33) m. The mean 6MWD was significantly greater, but not clinically meaningful, for the second test compared to the first at all time-points.
Conclusion: Telephone-mentoring for home-based walking demonstrated no benefit to exercise capacity. Two 6-minute walking tests at each time-point may not be necessary. Supervised exercise seems essential in PR. The challenge of incorporating exercise into daily life in COPD is substantial.
Chatwin et al (2016) [Randomised Controlled Trial] Randomised Crossover Trial of Telemonitoring in Chronic Respiratory Patients (TeleCRAFT Trial)
Design: Randomised crossover trial with 6 months of standard best practice clinical care [control group] and 6 months with the addition of telemonitoring.
Participants: 68 patients with chronic lung disease (38 with COPD; 30 with chronic respiratory failure due to other causes), who had a hospital admission for an exacerbation within 6 months of randomisation and either used long-term oxygen therapy or had an arterial oxygen saturation (SpO2) of <90% on air during the previous admission. Individuals received telemonitoring via broadband link to a hospital-based care team.
Outcome Measures: Primary outcome measure was time to first hospital admission for an acute exacerbation. Secondary outcome measures were hospital admissions, general practitioner consultations and home visits by nurses, quality of life measured by EuroQol-5D and hospital anxiety and depression (HAD) scale, and self-efficacy score (Stanford).
Results: Median (IQR) number of days to first admission showed no difference between the two groups—77 (114) telemonitoring, 77.5 (61) control (p=0.189). Hospital admission rate at 6 months increased (0.63 telemonitoring vs 0.32 control p=0.026). Home visits increased during telemonitoring; GP consultations were unchanged. Self-efficacy fell, while HAD depression score improved marginally during telemonitoring.
Conclusions: Telemonitoring added to standard care did not alter time to next acute hospital admission, increased hospital admissions and home visits overall, and did not improve quality of life in chronic respiratory patients
Cordova et al (2016) [Randomised Controlled Trial] A Telemedicine-Based Intervention Reduces the Frequency and Severity of COPD Exacerbation Symptoms: A Randomized Controlled Trial
Background: Patients with chronic obstructive pulmonary disease (COPD) may not recognize worsening symptoms that require intensification of therapy. They may also be reluctant to contact a healthcare provider for minor worsening of symptoms. A telemedicine application for daily symptom reporting may reduce these barriers and improve patient outcomes.
Materials and Methods: Patients hospitalized for a COPD exacerbation within the past year or using supplemental O2 were approached for participation. Patients received optimal COPD care and were given a telecommunication device for symptom reporting. Initial symptom scores were obtained while patients were in their usual state of health. Patients were randomly assigned to an intervention group or a control group [usual medical care]. The control group patients were instructed to seek medical care if their condition worsened. The intervention group symptom scores were assessed by a computer algorithm and compared with initial values. Scores 1 or more points above the initial score generated an alert, and patients were reviewed by a nurse and referred to a physician who prescribed treatment.
Results: Eighty-six patients were screened; 79 met entry criteria and were randomized (intervention group, n=39; control group, n=40). Twelve patients submitted five or fewer symptom reports and were excluded from the analysis. Daily peak flow and dyspnea scores improved only in the intervention group. There were no differences in hospitalization and mortality rates between groups. No serious adverse events were reported.
Conclusions: A telemedicine-based symptom reporting program facilitated early treatment of symptoms and improved lung function and functional status.
Franke et al (2016) [Randomised Controlled Trial] Telemonitoring of Home Exercise Cycle Training in Patients With COPD
Background: Regular physical activity is associated with reduced mortality in patients with chronic obstructive pulmonary disease (COPD). Interventions to reduce time spent in sedentary behavior could improve outcomes. The primary purpose was to investigate the impact of telemonitoring with supportive phone calls on daily exercise times with newly established home exercise bicycle training. The secondary aim was to examine the potential improvement in health-related quality of life and physical activity compared to baseline.
Methods: This prospective crossover-randomized study was performed over 6 months in stable COPD patients. The intervention phase [domiciliary training with supporting telephone calls] and the control phase [training without phone calls] were randomly assigned to the first or the last 3 months. In the intervention phase, patients were called once a week if they did not achieve a real-time monitored daily cycle time of 20 minutes. Secondary aims were evaluated at baseline and after 3 and 6 months. Health-related quality of life was measured by the COPD Assessment Test (CAT), physical activity by the Godin Leisure Time Exercise Questionnaire (GLTEQ).
Results: Of the 53 included patients, 44 patients completed the study (forced expiratory volume in 1 second 47.5%±15.8% predicted). In the intervention phase, daily exercise time was significantly higher compared to the control phase (24.2±9.4 versus 19.6±10.3 minutes). Compared to baseline (17.6±6.1), the CAT-score improved in the intervention phase to 15.3±7.6 and in the control phase to 15.7±7.3 units. The GLTEQ-score increased from 12.2±12.1 points to 36.3±16.3 and 33.7±17.3.
Conclusion: Telemonitoring is a simple method to enhance home exercise training and physical activity, improving health-related quality of life.
Ho et al (2016) [Randomised Controlled Trial] Effectiveness of Telemonitoring in Patients With Chronic Obstructive Pulmonary Disease in Taiwan-A Randomized Controlled Trial
Chronic obstructive pulmonary disease (COPD) is the leading cause of death worldwide, and poses a substantial economic and social burden. Telemonitoring has been proposed as a solution to this growing problem, but its impact on patient outcome is equivocal. This randomized controlled trial aimed to investigate effectiveness of telemonitoring in improving COPD patient outcome. In total, 106 subjects were randomly assigned to the telemonitoring (n = 53) or usual care (n = 53) group. During the two months following discharge, telemonitoring group patients had to report their symptoms daily using an electronic diary. The primary outcome measure was time to first re-admission for COPD exacerbation within six months of discharge. During the follow-up period, time to first re-admission for COPD exacerbation was significantly increased in the telemonitoring group than in the usual care group (p = 0.026). Telemonitoring was also associated with a reduced number of all-cause re-admissions (0.23 vs. 0.68/patient; p = 0.002) and emergency room visits (0.36 vs. 0.91/patient; p = 0.006). In conclusion, telemonitoring intervention was associated with improved outcomes among COPD patients admitted for exacerbation in a country characterized by a small territory and high accessibility to medical services. The findings are encouraging and add further support to implementation of telemonitoring as part of COPD care.
Ritchie et al (2016) [Randomised Controlled Trial] The E-Coach Technology-Assisted Care Transition System: A Pragmatic Randomized Trial
Care transitions from the hospital to home remain a vulnerable time for many patients, especially for those with heart failure (CHF) and chronic obstructive pulmonary disease (COPD). Despite regular use in chronic disease management, it remains unclear how technology can best support patients during their transition from the hospital. We sought to evaluate the impact of a technology-supported care transition support program on hospitalizations, days out of the community and mortality. Using a pragmatic randomized trial, we enrolled patients (511 enrolled, 478 analyzed) hospitalized with CHF/COPD to E-Coach, an intervention with condition-specific customization and in-hospital and post-discharge support by a care transition nurse (CTN), interactive voice response post-discharge calls, and CTN follow-up versus usual post-discharge care (UC). The primary outcome was 30-day rehospitalization. Secondary outcomes included 1. rehospitalization and death; and 2. days in the hospital and out of the community. E-Coach and UC groups were similar at baseline except for gender imbalance (p = 0.02). After adjustment for gender, our primary outcome, 30-day rehospitalization rates did not differ between the E-Coach and UC groups (15.0 vs. 16.3 %, adjusted hazard ratio [95 % confidence interval]: 0.94 [0.60, 1.49]). However, in the COPD subgroup, E-Coach was associated with significantly fewer days in the hospital (0.5 vs. 1.6, p = 0.03). E-Coach, an IVR-augmented care transition intervention did not reduce rehospitalization. The positive impact on our secondary outcome (days in hospital) among COPD patients, but not in CHF, may suggest that E-Coach may be more beneficial among patients with COPD.
Talboom-Kamp et al (2016) [Randomised Controlled Trial] e-Vita: Design of an Innovative Approach to COPD Disease Management in Primary Care Through eHealth Application
Background: COPD is a highly complex disease to manage as patients show great variation in symptoms and limitations in daily life. In the last decade self-management support of COPD has been introduced as an effective method to improve quality and efficiency of care, and to reduce healthcare costs. Despite the urge to change the organisation of health care and the potential of eHealth to support this, large-scale implementation in daily practice remains behind, especially in the Netherlands.
Methods: We designed a multilevel study, called e-Vita, to investigate different organisational implementation methods of a self-management web portal to support and empower patients with COPD in three different primary care settings. Using a parallel cohort design, the clinical effects of the web portal will be assessed using an interrupted times series (ITS) study design and measured according to changes in health status with the Clinical COPD Questionnaire (CCQ). The different implementations and net benefits of self-management through eHealth on clinical outcomes will be evaluated from human, organisational, and technical perspectives.
Discussion: To our knowledge this is the first study to combine different study designs that enable simultaneous investigation of clinical effects, as well as effects of different organisational implementation methods whilst controlling for confounding effects of the organisational characteristics. We hypothesize that an implementation with higher levels of personal assistance, and integrated in an existing care program will result in increased use of and satisfaction with the platform, thereby increasing health status and diminishing exacerbation and hospitalisation.
Vianello et al (2016) [Randomised Controlled Trial] Home Telemonitoring for Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Background: Although a number of studies have suggested that the use of Telemonitoring (TM) in patients with Chronic Obstructive Pulmonary Disease (COPD) can be useful and efficacious, its real utility in detecting Acute Exacerbation (AE) signaling the need for prompt treatment is not entirely clear. The current study aimed to investigate the benefits of a TM system in managing AE in advanced-stage COPD patients to improve their Health-Related Quality of Life (HRQL) and to reduce utilization of healthcare services.
Methods: A 12-month Randomised Controlled Trial (RCT) was conducted in the Veneto region of Italy. Adult patients diagnosed with Class III-IV COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification were recruited and provided a TM system to alert the clinical staff via a trained operator whenever variations in respiratory parameters fell beyond the individual’s normal range. The study’s primary endpoint was HRQL, measured by the Italian version of the two Short Form 36-item Health Survey (SF36v2). Its secondary endpoints were: scores on the Hospital Anxiety and Depression Scale (HADS); the number and duration of hospitalizations; the number of readmissions; the number of appointments with a pulmonary specialist; the number of visits to the emergency department; and the number of deaths.
Results: Three hundred thirty-four patients were enrolled and randomized into two groups for a 1-year period. At its conclusion, changes in the SF36 Physical and Mental Component Summary scores did not significantly differ between the TM and control groups [(-2.07 (8.98) vs -1.91 (7.75); p = 0.889 and -1.08 (11.30) vs -1.92 (10.92); p = 0.5754, respectively]. Variations in HADS were not significantly different between the two groups [0.85 (3.68) vs 0.62 (3.6); p = 0.65 and 0.50 (4.3) vs 0.72 (4.5); p = 0.71]. The hospitalization rate for AECOPD and/or for any cause was not significantly different in the two groups [IRR = 0.89 (95% CI 0.79-1,04); p = 0.16 and IRR = 0.91 (95% CI 0,75 – 1.04); p = 0.16, respectively]. The readmission rate for AECOPD and/or any cause was, however, significantly lower in the TM group with respect to the control one [IRR = 0.43 (95% CI 0.19-0.98); p = 0.01 and 0.46 (95% CI 0.24-0.89); p = 0.01, respectively].
Conclusion: Study results showed that in areas where medical services are well established, TM does not significantly improve HRQL in patients with COPD who develop AE. Although not effective in reducing hospitalizations, TM can nevertheless facilitate continuity of care during hospital-to-home transition by reducing the need for early readmission.
Vitacca et al (2016) [Randomised Controlled Trial] Is There Any Additional Effect of Tele-Assistance on Long-Term Care Programmes in Hypercapnic COPD Patients? A Retrospective Study
The evidence for tele-assistance (TA) in hypercapnic chronic obstructive pulmonary disease (COPD) patients on long-term oxygen therapy (LTOT) is scarce. The aim of this study was to evaluate the effects of addition of long-term TA to LTOT with or without non-invasive ventilation (NIV) in these patients. Retrospective analysis of a previous randomised study of patients on LTOT. According to the care programme patients were divided into Group 1: LTOT; Group 2: LTOT + NIV; Group 3: LTOT + TA and Group 4: LTOT + NIV+TA.
Primary Outcomes: Time to first exacerbation and hospitalisation during 12 months of long-term care. Risk of exacerbation was statistically different among groups (p = 0.0002). TA addition to NIV significantly reduced exacerbation risk when compared with that to all groups. Hospitalisation risk was statistically different among groups (p = 0.049). Addition of TA to LTOT but not to NIV significantly reduced hospitalisation risk when compared to Group 1 (p = 0.013). Risk of mortality did not differ among groups (p = 0.074). In chronically hypercapnic COPD patients on LTOT, 1. TA alone and with greater efficacy when combined with NIV may reduce the frequency of exacerbations and 2. TA added to LTOT, but not to NIV, may reduce the frequency of hospitalisations.
Vorrink et al (2016) [Randomised Controlled Trial] Efficacy of an mHealth Intervention to Stimulate Physical Activity in COPD Patients After Pulmonary Rehabilitation
Physical inactivity in patients with chronic obstructive pulmonary disease (COPD) is associated with poor health status and increased disease burden. The present study aims to test the efficacy of a previously developed mobile (m)Health intervention to improve or maintain physical activity in patients with COPD after pulmonary rehabilitation. A randomised controlled trial was performed in 32 physiotherapy practices in the Netherlands. COPD patients were randomised into intervention or usual care groups. The intervention consisted of a smartphone application for the patients and a monitoring website for the physiotherapists. Measurements were performed at 0, 3, 6 and 12 months. Physical activity, functional exercise capacity, lung function, health-related quality of life and body mass index were assessed.157 patients started the study and 121 completed it. There were no significant positive effects of the intervention on physical activity (at 0 months: intervention 5824±3418 steps per weekday, usual care 5717±2870 steps per weekday; at 12 months: intervention 4819±2526 steps per weekday, usual care 4950±2634 steps per weekday; p=0.811) or on the secondary end-points. There was a significant decrease over time in physical activity (p<0.001), lung function (p<0.001) and mastery (p=0.017), but not in functional exercise capacity (p=0.585). Although functional exercise capacity did not deteriorate, our mHealth intervention did not improve or maintain physical activity in patients with COPD after a period of pulmonary rehabilitation.
Zanaboni et al (2016) [Randomised Controlled Trial] Long-term Integrated Telerehabilitation of COPD Patients: A Multicentre Randomised Controlled Trial (iTrain)
Background: Pulmonary rehabilitation (PR) is an effective intervention for the management of people with chronic obstructive pulmonary disease (COPD). However, available resources are often limited, and many patients bear with poor availability of programmes. Sustaining PR benefits and regular exercise over the long term is difficult without any exercise maintenance strategy. In contrast to traditional centre-based PR programmes, telerehabilitation may promote more effective integration of exercise routines into daily life over the longer term and broaden its applicability and availability. A few studies showed promising results for telerehabilitation, but mostly with short-term interventions. The aim of this study is to compare long-term telerehabilitation with unsupervised exercise training at home and with standard care.
Methods: An international multicentre randomised controlled trial conducted across sites in three countries will recruit 120 patients with COPD. Participants will be randomly assigned to telerehabilitation, treadmill and control, and followed up for 2 years. The telerehabilitation intervention consists of individualised exercise training at home on a treadmill, telemonitoring by a physiotherapist via videoconferencing using a tablet computer, and self-management via a customised website. Patients in the treadmill arm are provided with a treadmill only to perform unsupervised exercise training at home. Patients in the control arm are offered standard care. The primary outcome is the combined number of hospitalisations and emergency department presentations. Secondary outcomes include changes in health status, quality of life, anxiety and depression, self-efficacy, subjective impression of change, physical performance, level of physical activity, and personal experiences in telerehabilitation.
Discussion: This trial will provide evidence on whether long-term telerehabilitation represents a cost-effective strategy for the follow-up of patients with COPD. The delivery of telerehabilitation services will also broaden the availability of PR and maintenance strategies, especially to those living in remote areas and with no access to centre-based exercise programmes.
Dyrvig et al (2015) [Cohort Study] A Cohort Study Following Up on a Randomised Controlled Trial of a Telemedicine Application in COPD Patients
Introduction: The studies that constitute the knowledge base of evidence based medicine represent only 5%-50% of patients seen in routine clinical practice. Therefore, whether the available evidence applies to the implementation of a particular service often remains unclear. Chronic obstructive pulmonary disease (COPD) is no exception.
Methods: In this article, the effects of implementing a telemedicine intervention for COPD patients were analysed using data collected before, during, and after a randomised controlled trial (RCT).More specifically, regression techniques using robust variance estimators were used to analyse whether the use of telemedicine, patient age, and gender could explain the risk of readmission, length of hospital admission, and death during a five-year observation period.
Results: Increased risk of readmission was significantly related to both use of telemedicine and increased age in three sub-periods of the study, whereas women showed a more pronounced risk of readmission than men only during and after the RCT period. The number of days admitted to hospital was higher for patients using telemedicine and being of older age. Risk of death during the observation period was decreased for patients using telemedicine and for female patients and increased for elderly patients. No interaction between intervention and time period was observed.Statistically significant relationships were identified between use of telemedicine and risk of readmission, days admitted to hospital, and death.
Discussion: Research on effect modification in telemedicine is essential in designing future implementation of interventions as it cannot be taken for granted that effectiveness follows from efficacy.
Jakobsen et al (2015) [Randomised Controlled Trial] Home-based Telehealth Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease: Findings From The Virtual Hospital Trial
Background: Telehealth interventions for patients with chronic obstructive pulmonary disease (COPD) have focused primarily on stable outpatients. Telehealth designed to handle the acute exacerbation that normally requires hospitalization could also be of interest. The aim of this study was to compare the effect of home-based telehealth hospitalization with conventional hospitalization for exacerbation in severe COPD.
Materials and Methods: A two-center, noninferiority, randomized, controlled effectiveness trial was conducted between June 2010 and December 2011. Patients with severe COPD admitted because of exacerbation were randomized 1:1 either to home-based telehealth hospitalization or to continue standard treatment and care at the hospital. The primary outcome was treatment failure defined as re-admission due to exacerbation in COPD within 30 days after initial discharge. The noninferiority margin was set at 20% of the control group’s risk of re-admission. Secondary outcomes were mortality, need for manual or mechanical ventilation or noninvasive ventilation, length of hospitalization, physiological parameters, health-related quality of life, user satisfaction, healthcare costs, and adverse events.
Results: In total, 57 patients were randomized: 29 participants in the telehealth group and 28 participants in the control group. Testing the incidence of re-admission within 30 days after discharge could not confirm noninferiority (lower 95% confidence limit, -24.8%; p=0.35). Results were also nonsignificant at 90 days (lower 95% CL, -16.2%; p=0.33) and 180 days (lower 95% CL, -16.6%; p =0.33) after discharge. Superiority testing on secondary outcomes showed nonsignificant differences between groups. Healthcare costs have not yet been evaluated.
Conclusions: Whether home-based telehealth hospitalization is noninferior to conventional hospitalization requires further investigation. The results indicate that a subgroup of patients with severe COPD can be treated for acute exacerbation at home using telehealth, without the physical presence of health professionals and with a proper organizational back-up.
McDowell et al (2015) [Randomised Controlled Trial] A Randomised Clinical Trial of the Effectiveness of Home-Based Health Care With Telemonitoring in Patients With COPD
We studied the effect of telemonitoring in addition to usual care compared to usual care alone in patients with chronic obstructive pulmonary disease (COPD). A total of 110 patients with moderate to severe COPD were recruited from a specialist respiratory service in Northern Ireland. Patients had at least two of: emergency department admissions, hospital admissions or emergency general practitioner contacts in the 12 months before the study. Exclusion criteria were patients who had any respiratory disorder other than COPD, or were cognitively unable to learn the process of monitoring. Patients were randomised to receive six months of home telemonitoring with usual care, or six months of usual care. The primary outcome measure was disease-specific quality of life, as measured by the St George’s Respiratory Questionnaire for COPD patients (SGRQ-C). Of 100 patients completing the study, 48 patients were randomised to telemonitoring and 52 patients were randomised to the control group. The SGRQ-C scores improved significantly in the intervention group compared to usual care (P = 0.001). The HADS anxiety score was significantly higher in the telehealth group compared to the usual care group (P = 0.01). There were significantly more contacts with the Community Respiratory Team in the telemonitoring group compared to the control group (P = 0.029). There were no significant between group differences in EQ-5D scores, HADS depression scores, GP activity, emergency department visits, hospital admissions or exacerbations. The total cost to the health service of the intervention over the 6-month study period was £2039, giving an estimated ICER of £203,900. In selected patients with COPD, telemonitoring was effective in improving health-related quality of life and anxiety, but was not a cost-effective intervention.
Ringbaek et al (2015) [Randomised Controlled Trial] Effect of Tele Health Care on Exacerbations and Hospital Admissions in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial
Background and Objective: Tele monitoring (TM) of patients with chronic obstructive pulmonary disease (COPD) has gained much interest, but studies have produced conflicting results. Our aim was to investigate the effect of TM with the option of video consultations on exacerbations and hospital admissions in patients with severe COPD.
Materials and Methods: Patients with severe COPD at high risk of exacerbations were eligible for the study. Of 560 eligible patients identified, 279 (50%) declined to participate. The remaining patients were equally randomized to either TM (n=141) or usual care (n=140) for the 6-month study period. TM comprised recording of symptoms, saturation, spirometry, and weekly video consultations. Algorithms generated alerts if readings breached thresholds. Both groups received standard care. The primary outcome was number of hospital admissions for exacerbation of COPD during the study period.
Results: Most of the enrolled patients had severe COPD [forced expiratory volume in 1 second <50%pred in 86% and ≥hospital admission for COPD in the year prior to enrollment in 45%, respectively, of the patients]. No difference in drop-out rate and mortality was found between the groups. With regard to the primary outcome, no significant difference was found in hospital admissions for COPD between the groups (P=0.74), and likewise, no difference was found in time to first admission or all-cause hospital admissions. Compared with the control group, TM group patients had more moderate exacerbations (ie treated with antibiotics/corticosteroid, but not requiring hospital admission; P<0.001), whereas the control group had more visits to outpatient clinics (P<0.001).
Conclusion: Our study of patients with severe COPD showed that TM including video consultations as add-on to standard care did not reduce hospital admissions for exacerbated COPD, but TM may be an alternative to visits at respiratory outpatient clinics. Further studies are needed to establish the optimal role of TM in the management of severe COPD.
Bentley et al (2020) [Feasibility Study] The Use of a Smartphone App and an Activity Tracker to Promote Physical Activity in the Management of Chronic Obstructive Pulmonary Disease: Randomized Controlled Feasibility Study
Background: Chronic obstructive pulmonary disease (COPD) is highly prevalent and significantly affects the daily functioning of patients. Self-management strategies, including increasing physical activity, can help people with COPD have better health and a better quality of life. Digital mobile health techniques have the potential to aid the delivery of self-management interventions for COPD. We developed an mHealth intervention (Self-Management supported by Assistive, Rehabilitative, and Telehealth technologies-COPD [SMART-COPD]), delivered via a smartphone app and an activity tracker, to help people with COPD maintain (or increase) physical activity after undertaking pulmonary rehabilitation (PR).
Objective: This study aimed to determine the feasibility and acceptability of using the SMART-COPD intervention for the self-management of physical activity and to explore the feasibility of conducting a future randomized controlled trial (RCT) to investigate its effectiveness.
Methods: We conducted a randomized feasibility study. A total of 30 participants with COPD were randomly allocated to receive the SMART-COPD intervention (n=19) or control (n=11). Participants used SMART-COPD throughout PR and for 8 weeks afterward (ie, maintenance) to set physical activity goals and monitor their progress. Questionnaire-based and physical activity-based outcome measures were taken at baseline, the end of PR, and the end of maintenance. Participants, and health care professionals involved in PR delivery, were interviewed about their experiences with the technology.
Results: Overall, 47% (14/30) of participants withdrew from the study. Difficulty in using the technology was a common reason for withdrawal. Participants who completed the study had better baseline health and more prior experience with digital technology, compared with participants who withdrew. Participants who completed the study were generally positive about the technology and found it easy to use. Some participants felt their health had benefitted from using the technology and that it assisted them in achieving physical activity goals. Activity tracking and self-reporting were both found to be problematic as outcome measures of physical activity for this study. There was dissatisfaction among some control group members regarding their allocation.
Conclusions: mHealth shows promise in helping people with COPD self-manage their physical activity levels. mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD. Simplicity and usability were more important for engagement with the SMART-COPD intervention than personalization; therefore, the intervention should be simplified for future use. Future evaluation will require consideration of individual factors and their effect on mHealth efficacy and use; within-subject comparison of step count values; and an opportunity for control group participants to use the intervention if an RCT were to be carried out. Sample size calculations for a future evaluation would need to consider the high dropout rates.
Holmner et al (2020) [Longitudinal Study] How Stable Is Lung Function in Patients With Stable Chronic Obstructive Pulmonary Disease When Monitored Using a Telehealth System? A Longitudinal and Home-Based Study
Background: Many telehealth systems have been designed to identify signs of exacerbations in patients with chronic obstructive pulmonary disease (COPD), but few previous studies have reported the nature of recorded lung function data and what variations to expect in this group of individuals. The aim of the study was to evaluate the nature of individual diurnal, day-to-day and long-term variation in important prognostic markers of COPD exacerbations by employing a telehealth system developed in-house.
Methods: Eight women and five men with COPD performed measurements (spirometry, pulse oximetry and the COPD assessment test (CAT)) three times per week for 4-6 months using the telehealth system. Short-term and long-term individual variations were assessed using the relative density and weekly means respectively. Quality of the spirometry measurements (forced expiratory volume in one second (FEV1) and inspiratory capacity (IC)) was assessed employing the criteria of American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.
Results: Close to 1100 measurements of both FEV1 and IC were performed during a total of 240 patient weeks. The two standard deviation ranges for intra-individual short-term variation were approximately ±210 mL and ± 350 mL for FEV1 and IC respectively. In long-term, spirometry values increased and decreased without notable changes in symptoms as reported by CAT, although it was unusual with a decrease of more than 50 mL per measurement of FEV1 between three consecutive measurement days. No exacerbation occurred. There was a moderate to strong positive correlation between FEV1 and IC, but weak or absent correlation with the other prognostic markers in the majority of the participants.
Conclusions: Although FEV1 and IC varied within a noticeable range, no corresponding change in symptoms occurred. Therefore, this study reveals important and, to our knowledge, previously not reported information about short and long-term variability in prognostic markers in stable patients with COPD. The present data are of significance when defining criteria for detecting exacerbations using telehealth strategies.
Rodriquez Hermosa et al (2020) [Cohort Study] Compliance and Utility of a Smartphone App for the Detection of Exacerbations in Patients With Chronic Obstructive Pulmonary Disease: Cohort Study
Background: In recent years, mobile health (mHealth)-related apps have been developed to help manage chronic diseases. Apps may allow patients with a chronic disease characterized by exacerbations, such as chronic obstructive pulmonary disease (COPD), to track and even suspect disease exacerbations, thereby facilitating self-management and prompt intervention. Nevertheless, there is insufficient evidence regarding patient compliance in the daily use of mHealth apps for chronic disease monitoring.
Objective: This study aimed to provide further evidence in support of prospectively recording daily symptoms as a useful strategy to detect COPD exacerbations through the smartphone app, Prevexair. It also aimed to analyze daily compliance and the frequency and characteristics of acute exacerbations of COPD recorded using Prevexair.
Methods: This is a multicenter cohort study with prospective case recruitment including 116 patients with COPD who had a documented history of frequent exacerbations and were monitored over the course of 6 months. At recruitment, the Prevexair app was installed on their smartphones, and patients were instructed on how to use the app. The information recorded in the app included symptom changes, use of medication, and use of health care resources. The patients received messages on healthy lifestyle behaviors and a record of their cumulative symptoms in the app. There was no regular contact with the research team and no mentoring process. An exacerbation was considered reported if medical attention was sought and considered unreported if it was not reported to a health care professional.
Results: Overall, compliance with daily records in the app was 66.6% (120/180), with a duration compliance of 78.8%, which was similar across disease severity, age, and comorbidity variables. However, patients who were active smokers, with greater dyspnea and a diagnosis of depression and obesity had lower compliance (P<.05). During the study, the patients experienced a total of 262 exacerbations according to daily records in the app, 99 (37.8%) of which were reported exacerbations and 163 (62.2%) were unreported exacerbations. None of the subject-related variables were found to be significantly associated with reporting. The duration of the event and number of symptoms present during the first day were strongly associated with reporting. Despite substantial variations in the COPD Assessment Test (CAT), there was improvement only among patients with no exacerbation and those with reported exacerbations. Nevertheless, CAT scores deteriorated among patients with unreported exacerbations.
Conclusions: The daily use of the Prevexair app is feasible and acceptable for patients with COPD who are motivated in their self-care because of frequent exacerbations of their disease. Monitoring through the Prevexair app showed great potential for the implementation of self-care plans and offered a better diagnosis of their chronic condition.
Objective: To describe the impact of a nurse-led telephone self-management support (SMS) service for people with asthma and COPD in Ireland.
Methods: A cross-sectional survey of all (442) SMS users, July 2016 to May 2017, described user demographics, self-reported experience, process and outcome. Population utilisation was estimated and compared across groups. Factors associated with key outcomes were identified.
Results: The response rate was 162 (36.7%). Utilisation varied across population groups. Reported satisfaction was high, and 56.0% of users without a written action plan reported developing one. Most users reported positive cognitive and affective outcomes indicating effective patient activation. Information pack receipt was independently associated with better outcomes (odds ratio = 11.4 (95% CI, 2.0, 216.6), p < 0.05).
Conclusion: A nurse-led telephone SMS intervention positively impacted self-management for people with asthma and COPD in Ireland.
Practice implications: Roll-out of SMS should include staff training to promote positive service user experience and should include routine monitoring and evaluation to assure equitable reach and quality of key evidence-based care processes.
Al Rajeh et al (2019) [Survey] Use, Utility and Methods of Telehealth for Patients With COPD in England and Wales: A Healthcare Provider Survey
Introduction: Although the effectiveness of domiciliary monitoring (telehealth) to improve outcomes in chronic obstructive pulmonary disease (COPD) is controversial, it is being used in the National Health Service (NHS).
Aim: To explore the use of teleheath for COPD across England and Wales, to assess the perceptions of clinicians employing telehealth in COPD and to summarise the techniques that have been used by healthcare providers to personalise alarm limits for patients with COPD enrolled in telehealth programmes.
Methods: A cross-sectional survey consisting of 14 questions was sent to 230 COPD community services in England and Wales. Questions were designed to cover five aspects of telehealth in COPD: purpose of use, equipment type, clinician perceptions, variables monitored and personalisation of alarm limits.
Results: 65 participants completed the survey from 52 different NHS Trusts. 46% of Trusts had used telehealth for COPD, and currently, 31% still provided telehealth services to patients with COPD. Telehealth is most commonly used for baseline monitoring and to allow early detection of exacerbations, with 54% believing it to be effective. The three most commonly monitored variables were oxygen saturation, heart rate and breathlessness. A variety of methods were used to set alarm limits with the majority of respondents believing that at least 40% of alarms were false.
Conclusion: Around one-third of responded community COPD services are using telehealth, believing it to be effective without robust evidence, with a variety of variables monitored, a variety of hardware and varying techniques to set alarm limits with high false alarm frequencies.
Alharbey and Chatterjee (2019) [Design Study] An mHealth Assistive System “MyLung” to Empower Patients With Chronic Obstructive Pulmonary Disease: Design Science Research
Background: Chronic obstructive pulmonary disease (COPD) comprises a group of progressive diseases that deteriorate lung functions. When patients cannot breathe, nothing else in their lives matter. Breathlessness has negative implications on patients’ lives, which leads to physical and psychological limitations. Moreover, the lack of relevant and updated information about the causes and consequences of the disease can exacerbate the problems of health literacy, information accessibility, and medical adherence.
Objective: The objective of this study is to design an innovative mobile health (mHealth) app system called MyLung that provides complete solutions in order to increase self-awareness and promote better self-care management. This system, an information technology artifact, includes three novel integrative modules: education, risk reduction, and monitoring.
Methods: The utility and effectiveness of the assistive mobile-based technology were evaluated using a mixed-methods approach. The study combined quantitative and qualitative research methods to thoroughly understand how the assistive mobile-based technology can influence patients’ behavioral intention to change their lifestyle. Thirty patients were categorized into two groups [intervention group and control group].
Results: The results from the quantitative analysis led to four follow-up interviews in the qualitative study. The results of the quantitative study provided significant evidence to show that the design of MyLung leads to a change in the awareness level, self-efficacy, and behavioral intention for patients with COPD. The t tests revealed a significant difference before and after using the mobile-based app with regard to the awareness level (mean 3.28 vs 4.56; t10=6.062; P<.001), self-efficacy (mean 3.11 vs 5.56; t10=2.96; P=.01), and behavioral intention (mean 2.91 vs 4.55; t10=3.212; P=.009). Independent sample t tests revealed significant differences between the intervention group and the control group in terms of the awareness level (mean 4.56 vs 3.31; t19=4.80; P<.001) and self-efficacy (mean 5.56 vs 3.66; t19=2.8; P<.01). Integration of findings from quantitative and qualitative studies reveled the impact of the design in a comprehensive manner. These inferences are referred to as meta-inferences in this study.
Conclusions: We designed an innovative assistive mobile-based technology to empower patients with COPD, which helped increase awareness and engage patients in self-care management activities. The assistive technology aims to inform patients about the risk factors of COPD and to improve access to relevant information. Meta-inferences that emerge from the research outputs contribute to research into chronic management information systems by helping us gain a more complete understanding of the potential impacts of this proposed mobile-based design on patients with chronic disease.
Bowler et al (2019) [Observational Study] Real-world Use of Rescue Inhaler Sensors, Electronic Symptom Questionnaires and Physical Activity Monitors in COPD
Background: Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease characterised by airflow obstruction and other morbidities such as respiratory symptoms, reduced physical activity and frequent bronchodilator use. Recent advances in personal digital monitoring devices can permit continuous collection of these data in COPD patients, but the relationships among them are not well understood.
Methods: 184 individuals from a single centre of the COPDGene cohort agreed to participate in this 3-week observational study. Each participant used a smartphone to complete a daily symptom diary [EXAcerbations of Chronic pulmonary disease Tool, EXACT], wore a wrist-worn accelerometer to record continuously physical activity and completed the Clinical Visit PROactive Physical Activity in COPD questionnaire. 58 users of metered dose inhalers for rescue were provided with an inhaler sensor, which time stamped each inhaler actuation.
Results: Rescue inhaler use was strongly correlated with E-RS:COPD score, while step counts were correlated with neither rescue use nor E-RS:COPD score. Frequent, unpatterned inhaler use pattern was associated with worse respiratory symptoms and less physical activity compared with frequent inhaler use with a regular daily pattern. There was a strong week-by-week correlation among measurements, suggesting that 1 week of monitoring is sufficient to characterise stable patients with COPD.
Discussion: The study highlights the interaction and relevance of personal real-time monitoring of respiratory symptoms, physical activity and rescue medication in patients with COPD. Additionally, visual displays of longitudinal data may be helpful for disease management to help drive conversations between patients and caregivers and for risk-based monitoring in clinical trials.
Buekers et al (2019) [Observational Study] Wearable Finger Pulse Oximetry for Continuous Oxygen Saturation Measurements During Daily Home Routines of Patients With Chronic Obstructive Pulmonary Disease (COPD) Over One Week: Observational Study
Background: Chronic obstructive pulmonary disease (COPD) patients can suffer from low blood oxygen concentrations. Peripheral blood oxygen saturation (SpO2), as assessed by pulse oximetry, is commonly measured during the day using a spot check, or continuously during one or two nights to estimate nocturnal desaturation. Sampling at this frequency may overlook natural fluctuations in SpO2.
Objective: This study used wearable finger pulse oximeters to continuously measure SpO2 during daily home routines of COPD patients and assess natural SpO2 fluctuations.
Methods: A total of 20 COPD patients wore a WristOx2 pulse oximeter for 1 week to collect continuous SpO2 measurements. A SenseWear Armband simultaneously collected actigraphy measurements to provide contextual information. SpO2 time series were preprocessed and data quality was assessed afterward. Mean SpO2, SpO2 SD, and cumulative time spent with SpO2 below 90% (CT90) were calculated for every day, day in rest, and night to assess SpO2 fluctuations.
Results: A high percentage of valid SpO2 data (daytime: 93.27%; nocturnal: 99.31%) could be obtained during a 7-day monitoring period, except during moderate-to-vigorous physical activity (MVPA) (67.86%). Mean nocturnal SpO2 (89.9%, SD 3.4) was lower than mean daytime SpO2 in rest (92.1%, SD 2.9; P<.001). On average, SpO2 in rest ranged over 10.8% (SD 4.4) within one day. Highly varying CT90 values between different nights led to 50% (10/20) of the included patients changing categories between desaturator and nondesaturator over the course of 1 week.
Conclusions: Continuous SpO2 measurements with wearable finger pulse oximeters identified significant SpO2 fluctuations between and within multiple days and nights of patients with COPD. Continuous SpO2 measurements during daily home routines of patients with COPD generally had high amounts of valid data, except for motion artifacts during MVPA. The identified fluctuations can have implications for telemonitoring applications that are based on daily SpO2 spot checks. CT90 values can vary greatly from night to night in patients with a nocturnal mean SpO2 around 90%, indicating that these patients cannot be consistently categorized as desaturators or nondesaturators. We recommend using wearable sensors for continuous SpO2 measurements over longer time periods to determine the clinical relevance of the identified SpO2 fluctuations.
Chan et al (2019) [Evaluation Study] A Smartphone Oximeter With a Fingertip Probe for Use During Exercise Training: Usability, Validity and Reliability in Individuals With Chronic Lung Disease and Healthy Controls
Background and aim: Telehealth is a strategy to expand the reach of pulmonary rehabilitation (PR). Smartphones can monitor and transmit oxygen saturation (SpO2) and heart rate (HR) data to ensure patient safety during home-based or other exercise. The purpose of this study was to evaluate the usability, validity and reliability of a Kenek O2 pulse oximeter and custom prototype smartphone application [smartphone oximeter] during rest and exercise in healthy participants and those with chronic lung disease.
Methods: Fifteen individuals with chronic lung disease and 15 healthy controls were recruited. SpO2 and HR were evaluated at rest and during cycling and walking. SpO2 was valid if the mean bias was within +±2%, the level of agreement (LoA) was within ±4%; HR was valid if the mean bias was within ±5 beats per min (bpm), LoA was within ±10bpm. Usability was assessed with a questionnaire and direct observation.
Results: The smartphone oximeter was deemed easy to use. At rest, SpO2 measures were valid in both groups (bias <2%, lower bound LoA -2 to 3%). During exercise, SpO2 measurement did not meet validity and reliability thresholds in the patients with chronic lung disease, but was accurate for the healthy controls. HR recording during exercise or rest was not valid (LoA>10bpm) in either group.
Conclusions: The smartphone oximeter did not record HR or SpO2 accurately in patients with chronic lung disease during exercise, although SpO2 was valid at rest. During exercise, patients with chronic lung disease should pause to ensure greatest accuracy of SpO2 and HR measurement.
Chung et al (2019) [Design Study] Remote Pulmonary Function Test Monitoring in Cloud Platform via Smartphone Built-in Microphone
With an aging population that continues to grow, health care technology plays an increasingly active role, especially for chronic disease management. In the health care market, cloud platform technology is becoming popular, as both patients and physicians demand cost efficiency, easy access to information, and security. Especially for asthma and chronic obstructive pulmonary disease (COPD) patients, it is recommended that pulmonary function test (PFT) be performed on a daily basis. However, it is difficult for patients to frequently visit a hospital to perform the PFT. In this study, we present an application and cloud platform for remote PFT monitoring that can be directly measured by smartphone microphone with no external devices. In addition, we adopted the IBM Watson Internet-of-Things (IoT) platform for PFT monitoring, using a smartphone’s built-in microphone with a high-resolution time-frequency representation. We successfully demonstrated real-time PFT monitoring using the cloud platform. The PFT parameters of FEV1/FVC (%) could be remotely monitored when a subject performed the PFT test. As a pilot study, we tested 13 healthy subjects, and found that the absolute error mean was 4.12 and the standard deviation was 3.45 on all 13 subjects. With the developed applications on the cloud platform, patients can freely measure the PFT parameters without restriction on time and space, and a physician can monitor the patients’ status in real time. We hope that the PFT monitoring platform will work as a means for early detection and treatment of patients with pulmonary diseases, especially those having asthma and COPD.
Ding et al (2019) [Review] Digital Health for COPD Care: The Current State of Play
Chronic obstructive pulmonary disease (COPD) imposes a huge burden to our healthcare systems and societies. To alleviate the burden, digital health-“the use of digital technologies for health”-has been recognized as a potential solution for improving COPD care at scale. The aim of this review is to provide an overview of digital health interventions in COPD care. We accordingly reviewed recent and emerging evidence on digital transformation approaches for COPD care focusing on: 1. self-management; 2. in-hospital care; 3. post-discharge care; 4. hospital-at-home; 5. ambient environment; and 6. public health surveillance. The emerging approaches included digital-technology-enabled homecare programs, electronic records, big data analytics, and environment-monitoring applications. The digital health approaches of telemonitoring, telehealth and mHealth support the self-management, post-discharge care, and hospital-at-home strategy, with prospective effects on reducing acute COPD exacerbations and hospitalizations. Electronic records and classification tools have been implemented; and their effectiveness needs to be further evaluated in future studies. Air pollution concentrations in the ambient environment are associated with declined lung functions and increased risks for hospitalization and mortality. In all the digital transformation approaches, clinical evidence on reducing mortality, the ultimate goal of digital health intervention, is often inconsistent or insufficient. Digital health transformation provides great opportunities for clinical innovations and discovery of new intervention strategies. Further research remains needed for achieving reliable improvements in clinical outcomes and cost-benefits in future studies.
Farias et al (2019) [Observation Study] Innovating the Treatment of COPD Exacerbations: A Phone Interactive Telesystem to Increase COPD Action Plan Adherence
Introduction: Self-management interventions with Written Action Plans and case management support have been shown to improve outcomes in patients with chronic obstructive pulmonary disease (COPD). Novel telehealth technologies may improve self-management interventions. The objectives of this study were to determine whether the use of an interactive phone telesystem increases Action Plan adherence, improves exacerbation recovery and reduces healthcare use in a real-life practice of a COPD clinic.
Methods: Initially, 40 patients were followed by a COPD telesystem for 1 year. Detailed data from patients’ behaviours during exacerbations was recorded. The telesystem use was then extended to 256 patients from a real-life COPD clinic. Healthcare utilisation for the year before and after telesystem enrolment was then assessed through hospital administrative databases.
Results: Thirty-three of the 40 patients completed the initial 1-year study. Eighty-one exacerbations were reported in the 1-year follow-up. Action Plan adherence was observed for 72% of the exacerbations and those who were adherent had a significantly faster exacerbation recovery time. The large-scale implementation of the telesystem resulted in a significant decrease in the proportion of patients with ≥1 respiratory-related emergency room (ER) visits (120 before vs 110 after enrolment, p<0.001) and with ≥1 COPD-related hospitalisations (75 before vs 65 after enrolment, p<0.001).
Discussion: COPD Written Action Plan adherence was further enhanced with the use of telehealth technologies in a specialised clinic with experience in COPD self-management. Patients followed by the telesystem recovered faster from exacerbations and had a further decrease in COPD-related ER visits and hospitalisations.
Fung et al (2019) [Feasibility Study] Design and Benchmark Testing for Open Architecture Reconfigurable Mobile Spirometer and Exhaled Breath Monitor With GPS and Data Telemetry
Portable and wearable medical instruments are poised to play an increasingly important role in health monitoring. Mobile spirometers are available commercially, and are used to monitor patients with advanced lung disease. However, these commercial monitors have a fixed product architecture determined by the manufacturer, and researchers cannot easily experiment with new configurations or add additional novel sensors over time. Spirometry combined with exhaled breath metabolite monitoring has the potential to transform healthcare and improve clinical management strategies. This research provides an updated design and benchmark testing for a flexible, portable, open access architecture to measure lung function, using common Arduino/Android microcontroller technologies. To demonstrate the feasibility and the proof-of-concept of this easily-adaptable platform technology, we had 43 subjects (healthy, and those with lung diseases) perform three spirometry maneuvers using our reconfigurable device and an office-based commercial spirometer. We found that our system compared favorably with the traditional spirometer, with high accuracy and agreement for forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC), and gas measurements were feasible. This provides an adaptable/reconfigurable open access personalized medicine platform for researchers and patients, and new chemical sensors and other modular instrumentation can extend the flexibility of the device in the future.
Gaveikaite et al (2019) [Mapping Study] A Systematic Map and In-Depth Review of European Telehealth Interventions Efficacy for Chronic Obstructive Pulmonary Disease
Background: Evidence to support the implementation of telehealth (TH) interventions in the management of chronic obstructive pulmonary disease (COPD) varies throughout Europe. Despite more than ten years of TH research in COPD management, it is still not possible to define which TH interventions are beneficial to which patient group. Therefore, informing policymakers on TH implementation is complicated. We aimed to examine the provision and efficacy of TH for COPD management to guide future decision-making.
Methods: A mapping study of twelve systematic reviews of TH interventions for COPD management was conducted. This was followed by an in-depth review of fourteen clinical trials performed in Europe extracted from the systematic reviews. Efficacy outcomes for COPD management were synthesized.
Results: The mapping study revealed that systematic reviews with a meta-analysis often report positive clinical outcomes. Despite this, we identified a lack of pragmatic trial design affecting the synthesis of reported outcomes. The in-depth review visualized outcomes for three TH categories, which revealed a plethora of heterogeneous outcomes. Suggestions for reporting within these three outcomes are synthesized as targets for future empirical research reporting.
Conclusion: The present study indicates the need for more standardized and updated systematic reviews. Policymakers should advocate for improved TH trial designs, focusing on the entire intervention’s adoption process evaluation. One of the policymakers’ priorities should be the harmonization of the outcome sets, which would be considered suitable for deciding about subsequent reimbursement. We propose possible outcome sets in three TH categories which could be used for discussion with stakeholders.
Guber et al (2019) [Observation Study] Wrist-Sensor Pulse Oximeter Enables Prolonged Patient Monitoring in Chronic Lung Diseases
Pulse oximetry is an important diagnostic tool in monitoring and treating both in-patients and ambulatory patients. Modern pulse oximeters exploit different body sites: eg fingertip, forehead or earlobe). All those are bulky and uncomfortable, resulting in low patient compliance. Therefore, we evaluated the accuracy and precision of a wrist-sensor pulse oximeter [Oxitone-1000, Oxitone Medical] vs. the traditional fingertip device. Fifteen healthy volunteers and 23 patients were recruited. The patient group included chronic obstructive pulmonary disease (COPD) (N = 8), asthma (N = 6), sarcoidosis (N = 5) and others. Basic demographic data, skin tone type, smoking status and medical history were recorded. Blood oxygen level (SpO2) and pulse-rate values were determined by a non-invasive pulse oximeter [Reference, a conventional FDA-cleared fingertip pulse oximeter] and by Oxitone-1000. All tests were performed in singleton and in a blinded fashion. The measurements were done in sitting and standing positions, as well as after a 6-min walk test. The mean age was 60.4 ± 9.83 years, 55% were male. No significant differences were observed between the wrist-sensor and the traditional fingertip pulse oximeters in all tested parameters. Mean SpO2 was 96.45% vs. 97.18% and the mean pulse was 74.64 vs. 74.6 bpm (Oxitone-1000 vs. Reference, respectively, p < 0.0001). Precision rate was 2.28472% and the accuracy was met. The Oxitone-1000 is both accurate and precise for SpO2 and pulse measurements during daily activities of pulmonary patients, and is not inferior to standard devices for spot checking or short period examinations. Its wrist-sensor design is comfortable and provides the advantage of extended use.
Knox et al (2019) [Feasibility Study] Safety, Feasibility, and Effectiveness of Virtual Pulmonary Rehabilitation in the Real World
Purpose: To assess the feasibility, safety, and effectiveness of a VIrtual PulmonAry Rehabilitation (VIPAR) program in a real-world setting.
Patients and methods: Twenty-one patients with stable chronic lung disease at a spoke site received (VIPAR) through live video conferencing with a hub where 24 patients were receiving 14 sessions of standard, outpatient, multi-disciplinary pulmonary rehabilitation (PR) in a hospital. We studied three such consecutive PR programs with 6-10 patients at each site. The hub had a senior physiotherapist, occupational therapist, exercise assistant, and guest lecturer, and the spoke usually had only an exercise instructor and nurse present. Uptake, adverse events (AEs), and early clinical changes were compared within and between groups. Travel distances were estimated using zip codes.
Results: Mean attendance was 11.0 sessions in the hub and 10.5 sessions in the spoke (P=0.65). There was a single (mild) AE (hypoglycemia) in all three hub programs and no AEs in the three spoke programs. Mean COPD Assessment Test scores improved from 25.3 to 21.5 in the hub (P<0.001, 95% CI 2.43-5.17) and from 23.4 to 18.8 (P<0.001, 2.23-7.02) in the spoke group, with no difference between the groups (P=0.51, -3.35-1.70). Mean incremental shuttle walk test scores improved from 142 to 208 m (P<0.001, 75-199) in the hub and from 179 to 316 minutes in the spoke (P<0.001, 39.3-92.4), with a greater improvement in the spoke (P=0.025, 9.31-133). Twenty-one patients saved a total of 8,609.8 miles over the three programs by having the PR in their local spoke, rather than traveling to the usual nearest (hospital) hub.
Conclusion: Video-conferencing, which links a local site to a standard PR program is feasible, safe, and demonstrates at least equivalent short-term clinical gains. Throughput can be increased, with less staffing ratios and significantly less traveling.
Locke et al (2019) [Retrospective Chart Review] Using Video Telehealth to Facilitate Inhaler Training in Rural Patients With Obstructive Lung Disease
Background: Proper inhaler technique is important for effective drug delivery and symptom control in chronic obstructive pulmonary disease (COPD) and asthma, yet not all patients receive inhaler instructions.
Introduction: Using a retrospective chart review of participants in a video telehealth inhaler training program, the study compared inhaler technique within and between monthly telehealth visits and reports associated with patient satisfaction.
Materials and methods: Seventy-four (N = 74) rural patients prescribed ≥1 inhaler participated in three to four pharmacist telehealth inhaler training sessions using teach-to-goal methodology. Within and between visit inhaler technique scores are compared, with descriptive statistics of pre- and postprogram survey results including program satisfaction and computer technical issues. Healthcare utilization is compared between pre- and post-training periods.
Results: Sixty-nine (93%) patients completed all three to four video telehealth inhaler training sessions. During the initial visit, patients demonstrated improvement in inhaler technique for metered dose inhalers (albuterol, budesonide/formoterol), dry powder inhalers (formoterol, mometasone, tiotropium), and soft mist inhalers (ipratropium/albuterol) (p < 0.01 for all). Improved inhaler technique was sustained at 2 months (p < 0.01). Ninety-four percent of participants were satisfied with the program. Although technical issues were common, occurring among 63% of attempted visits, most of these visits (87%) could be completed. There was no significant difference in emergency department visits and hospitalizations pre- and post-training.
Discussion: This study demonstrated high patient acceptance of video telehealth training and objective improvement in inhaler technique.
Conclusions: Video telehealth inhaler training using the teach-to-goal methodology is a promising program that improved inhaler technique and access to inhaler teaching for rural patients with COPD or asthma.
Lyth et al (2019) [Observational Study] Can a Telemonitoring System Lead to Decreased Hospitalization in Elderly Patients?
Introduction: Expanding populations of elderly patients with chronic obstructive pulmonary disease (COPD) or heart failure (HF) require more healthcare. A four-year telehealth intervention – the Health Diary system based on digital pen technology – was implemented. We hypothesized that study patients with advanced COPD or HF would have lower rates of hospitalization when using the Health Diary. The aim was to investigate the effects of the intervention on healthcare costs and the number of hospitalizations, as well as other care required in COPD and HF patients.
Methods: Patients were introduced to the telemonitoring system which was supervised by a specialized hospital-based home care (HBHC) unit. Staff associated with this unit were responsible for the healthcare provided. The study included patients with COPD or HF, aged ≥ 65 years who were frequently hospitalized due to exacerbations – at least two inpatient episodes within the last 12 months. Observed number of hospitalizations and total healthcare costs were compared with the expected values, which were calculated using the generalized estimating equations (GEE) method.
Results: A total of 36 COPD and 58 HF patients with advanced stages of disease were included. The number of hospitalizations was significantly reduced for both HF and COPD patients participating in telemonitoring. Accordingly, hospitalization costs were significantly reduced for both groups, but the total healthcare cost was not significantly different from the expected costs.
Conclusion: A telemonitoring system, the Health Diary, combined with a specialized HBHC unit significantly decreases the need for hospital care in elderly patients with advanced HF or COPD without increasing total healthcare costs.
Pericleous and van Staa (2019) [Review] The Use of Wearable Technology to Monitor Physical Activity in Patients With COPD: A Literature Review
Background: Physical activity is an important predictor for survival in patients with COPD. Wearable technology, such as pedometer or accelerometer, may offer an opportunity to quantify physical activity and evaluate related health benefits in these patients.
Objectives: To assess the performance of wearable technology in monitoring and improving physical activity in COPD patients from published studies.
Methods: Literature search of Medline, Cochrane, Dare, Embase and PubMed databases was made to find relevant articles that used wearable technology to monitor physical activity in COPD patients.
Results: We identified 13 studies that used wearable technology, a pedometer or an accelerator, to monitor physical activity in COPD patients. Of these, six studies were randomized controlled trials (RCTs) which used the monitors as part of the intervention. Two studies reported the same outcomes and comparable units. They had measured the difference that the intervention makes on the number of steps taken daily by the patients. The results were highly heterogeneous with I2=92%. The random-effects model gave an effect outcome on the number of steps taken daily of 1,821.01 [-282.71; 3,924.74] in favor of the wearable technology. Four of the 13 studies have reported technical issues with the use of the wearable technology, including high signal-to-noise ratio, memory storage problems and inaccuracy of counts. While other studies did not mention any technical issues, it is not clear whether these did not experience them or chose not to report them.
Conclusions: Our literature search has shown that data on the use of wearable technology to monitor physical activity in COPD patients are limited by the small number of studies and their heterogeneous study design. Further research and better-designed RCTs are needed to provide reliable results before physical activity monitors can be implemented routinely for COPD patients.
Rutkowski et al (2019) [Evaluation] Effect of Virtual Reality-Based Rehabilitation on Physical Fitness in Patients With Chronic Obstructive Pulmonary Disease
The aim of the study was to evaluate the effects of rehabilitation in patients with chronic obstructive pulmonary disease (COPD) using the Kinect system during stationary rehabilitation. The study included 68 patients with COPD (35 men, 33 women, mean age 61.3 ± 3.7). The subjects were randomly assigned to one of the two experimental groups described below. Group I included 34 patients – non-participants in Kinect training. Group II included 34 patients – participants in Kinect training. In all patients before and after rehabilitation physical fitness was assessed using the Senior Fitness Test (SFT). The Xbox 360 and Kinect motion sensor were used to carry out virtual reality training. In group I, statistically significant improvements in SFT performance were observed. Patients in group II also showed statistically significant improvement in physical fitness in all attempts of the SFT. Virtual rehabilitation training in patients with COPD seems to be a practical and beneficial intervention capable of enhancing mobility and physical fitness.
Soler et al (2019) [Review] Validation of Respiratory Rate Measurements From Remote Monitoring Device in COPD Patients
With healthcare objectives and budget constraint, remote monitoring of chronic obstructive pulmonary disease (COPD) patients is an important challenge in most European countries. Recent works have shown that it is possible to predict COPD exacerbation based on monitoring of simple parameters, such as the respiratory rate (RR) of the patient in spontaneous ventilation or under non-invasive ventilation. Until now, these devices do not allow a daily automatic data remote transmission, or it is restricted to patients under mechanical ventilation. TeleOx® (SRETT, Boulogne-Billancourt, France), the first oxygen flow rate remote monitoring device, also allows a RR measurement by associating a pressure sensor and a fluidic oscillator flow sensor. A median RR is output every 5 minutes based on time interval between two consecutive respiratory cycles. In this study, we compared the corresponding RR measurements between TeleOx® and the reference polygraph (Nox-T3®, Nox Medical Inc. Reykjavik, Iceland) from COPD patients under nasal oxygen therapy with flow rates between 0.5 and 5.0 litres per minute. Patients without mechanical ventilation and without any other respiratory pathology were eligible to the study if they would undergo a ventilatory polygraph record for other reasons.
Clarke et al (2018) [Evaluation] Evaluation of the National Health Service (NHS) Direct Pilot Telehealth Program: Cost-Effectiveness Analysis
Objective: To evaluate the cost-effectiveness of a pilot telehealth program applied to a wide population of patients with chronic obstructive pulmonary disease (COPD).
Design: Vital signs data were transmitted from the home of the patient on a daily basis using a patient monitoring system for review by community nurse to assist decisions on management.
Setting: Community services for patients diagnosed with COPD.
Participants: Two Primary Care Trusts (PCTs) enrolled 321 patients diagnosed with COPD into the telehealth program. Two hundred twenty-seven (n = 227) patients having a complete baseline record of at least 88 days of continuous remote monitoring and meeting all inclusion criteria were included in the statistical analysis.
Intervention: Remote monitoring.
Methods: Resource and cost data associated with patient events (inpatient hospitalization, accident and emergency, and home visits) 12 months before, immediately before and during monitoring, equipment, start-up, and administration were collected and compared to determine cost-effectiveness of the program.
Main outcome measures: Cost-effectiveness of program, impact on resource usage, and patterns of change in resource usage.
Results: Cost-effectiveness was determined for the two PCTs and the two periods before monitoring to provide four separate estimates. Cost-effectiveness had high variance both between the PCTs and between the comparison periods ranging from a saving of £140,800 ($176,000) to an increase of £9,600 ($12,000). The average saving was £1,023 ($1,280) per patient per year. The largest impact was on length of stay with a fall in the average length of inpatient care in PCT1 from 11.5 days in the period 12 months before monitoring to 6.5 days during monitoring, and similarly in PCT2 from 7.5 to 5.2 days.
Conclusion: There was a wide discrepancy in the results from the two PCTs. This places doubt on outcomes and may indicate also why the literature on cost-effectiveness remains inconclusive. The wide variance on savings and the uncertainty of monitoring cost do not allow a definitive conclusion on the cost-effectiveness as an outcome of this study. It might well be that the average saving was £1,023 ($1,280) per patient per year, but the variance is too great to allow this to be statistically significant. Each locality-based clinical service provides a service to achieve the same clinical goal, but it does so in significantly different ways. The introduction of remote monitoring has a profound effect on team learning and clinical practice and thus distorts the cost-effectiveness evaluation of the use of the technology. Cost-effectiveness studies will continue to struggle to provide a definitive answer because outcome measurements are too dependent on factors other than the technology.
Miron Rubio et al (2018) [Review] Telemonitoring and Home Hospitalization in Patients With Chronic Obstructive Pulmonary Disease: Study TELEPOC
Background: Chronic obstructive pulmonary disease (COPD) is a major consumer of healthcare resources, with most costs related to disease exacerbations. Telemonitoring of patients with COPD may help to reduce the number of exacerbations and/or the related costs. On the other hand, home hospitalization is a cost-saving alternative to inpatient hospitalization associated with increased comfort for patients. The results are reported regarding using telemonitoring and home hospitalization for the management of patients with COPD.
Methods: Twenty-eight patients monitored their health parameters at home for six months. A nurse remotely revised the collected parameters and followed the patients as programmed. A home care unit was dispatched to the patients’ home if an alarm signal was detected. The outcomes were compared to historical data from the same patients.
Results: The number of COPD exacerbations during the study period did not reduce but the number of hospital admissions decreased by 60% and the number of emergency room visits by 38%. On average, costs related to utilization of healthcare resources were reduced by €1,860.80 per patient per year.
Conclusions: Telemonitoring of patients with COPD combined with home hospitalization may allow for a reduction in healthcare costs, although its usefulness in preventing exacerbations is still unclear.
Milkowska-Dymanowska (2018) [Pilot Study] A Pilot Study of Daily Telemonitoring to Predict Acute Exacerbation in Chronic Obstructive Pulmonary Disease
Background: Exacerbations of COPD (ECOPD) are important events in the course of COPD and they accelerate the rate of decline of lung function, and exacerbations requiring hospitalization are associated with significant mortality. Therefore, developing approaches of prevention and early treatment of ECOPDs are of special clinical interests. One of such approaches is telecare, including home telemonitoring.
Material and methods: Daily telemonitoring of HR, BP, SpO2 and spirometry was performed. Variables were compared using the bootstrap-boosted inference tests: the paired t-test or Wilcoxon signed rank test, depending on data normality, and categorical variables were compared using exact McNemar’s test.
Results: Nineteen patients were included to the study. We observed significant decrease in SpO2 7 days preceding ECOPD (P = 0.007; Pbootstrap-boosted = 0.005) and increase in number of events of day-to-day decrease in oxygen saturation >4% in the period of 7 days preceding ECOPD versus reference period (P = 0.02).
Conclusions: Oxygen saturation telemonitoring would be successfully used in predicting ECOPD. Recording of day-to-day decrease in oxygen saturation >4% as alarming events would be effective approach which would be easily implemented in telemonitoring devices, however this outcome should be further validated in larger size samples.
O’Hoski et al (2018) [Review] Use of telemedicine in the assessment of patients referred for pulmonary rehabilitation
Rationale: Due to the high global prevalence and economic burden of COPD, there is growing interest in new approaches to reduce the time from referral to assessment for rehabilitation, especially among those in remote communities.
Objectives: To describe the structure of a pilot teleconsultation (TC) service for people referred for inpatient pulmonary rehabilitation (PR) and the characteristics of patients seen over four years.
Methods: Patient and clinic visit information since inception of the TC service in 2012 was retrieved from the electronic record of the respiratory medicine service at West Park Healthcare Centre. Descriptive statistics were calculated for patient characteristics and TC data.
Main results: From January 2012 to December 2015, 112 patients were booked for TC with the majority (n = 90, 80%) attending at least once. Of the 90 attendees, 78 (86%) were seen for assessment for inpatient PR and 61 of them (78%) were subsequently enrolled. Of these 78 patients, the majority (n = 61, 78%) had chronic obstructive pulmonary disease (COPD) as their primary lung condition and they resided in 46 locations across Ontario as well as in Newfoundland, Alberta and New Brunswick. The patients located in Ontario were saved a total of 70,070 km in travel which translates to a travel-only cost savings of $28,028.
Conclusions: TC is an alternative to in-person visits for the assessment of patients referred for PR. It results in meaningful cost savings and increased convenience for the patient and will assist clinicians in identifying those for whom PR would be a valuable intervention.
Siddiqui and Morshed (2018) [Review] Severity Classification of Chronic Obstructive Pulmonary Disease and Asthma With Heart Rate and SpO2 Sensors
Asthma and Chronic Obstructive Pulmonary Disease are chronic and long-term lung diseases. Disease monitoring with minimal sensors with high efficacy can make the disease control simple and practical for patients. We propose a model for the severity assessment of the diseases through wearables and compatible with mobile health applications, using only heart rate and SpO2 from pulse oximeter sensor. Patient data were obtained from the MIMIC- III Waveform Database Matched Subset. The dataset consists of 158 subjects. Both heart rate and SpO2 signal of patients are analyzed via the proposed algorithm to classify the severity of the diseases. Strategically, a rule-based threshold approach in real time evaluation is considered for the categorization scheme. Furthermore, a method is proposed to assess severity as an Event of Interest (EOI) from the computed metrics in retrospective. This type of autonomous system for real-time evaluation of patient’s condition has the potential to improve individual health through continual monitoring and self- management, as well as improve the health status of the overall Smart and Connected Community (SCC).
Sumino et al (2018) [Feasibility Study] Use of a Remote Inhaler Monitoring Device to Measure Change in Inhaler Use With Chronic Obstructive Pulmonary Disease Exacerbations
Background: Remote inhaler monitoring is an emerging technology that enables the healthcare team to monitor the time and location of a patient’s inhaler use. We assessed the feasibility of remote inhaler monitoring for chronic obstructive pulmonary disease (COPD) patients and the pattern of albuterol inhaler use associated with COPD exacerbations.
Methods: Thirty-five participants with COPD used an electronic inhaler sensor for 12 weeks which recorded the date and time of each albuterol actuation. Self-reported COPD exacerbations and healthcare utilization were assessed monthly. We used generalized estimating equations with a logit link to compare the odds of an exacerbation day to a nonexacerbation day by the frequency of daily albuterol use.
Results: Average daily albuterol use on nonexacerbation days varied greatly between patients, ranging from 1.5 to 17.5 puffs. There were 48 exacerbation events observed in 29 participants during the study period, of which 16 were moderate-to-severe exacerbations. During the moderate-to-severe exacerbation days, the median value in average daily albuterol use increased by 14.1% (interquartile range: 2.7%-56.9%) compared to average nonexacerbation days. A 100% increase in inhaler use was associated with increased odds of a moderate-to severe exacerbation (odds ratio 1.54; 95% CI: 1.21-1.97). Approximately 74% of participants reported satisfaction with the sensor.
Conclusions: The electronic inhaler sensor was well received in older patients with COPD over a 12-week period. Increased albuterol use captured by the device was associated with self-reported episodes of moderate-to-severe exacerbations.
Remote patient monitoring should reduce mortality rates, improve care, and reduce costs. We present an overview of the available technologies for the remote monitoring of chronic obstructive pulmonary disease (COPD) patients, together with the most important medical information regarding COPD in a language that is adapted for engineers. Our aim is to bridge the gap between the technical and medical worlds and to facilitate and motivate future research in the field. We also present a justification, motivation, and explanation of how to monitor the most important parameters for COPD patients, together with pointers for the challenges that remain. Additionally, we propose and justify the importance of electrocardiograms (ECGs) and the arterial carbon dioxide partial pressure (PaCO2) as two crucial physiological parameters that have not been used so far to any great extent in the monitoring of COPD patients. We cover four possibilities for the remote monitoring of COPD patients: continuous monitoring during normal daily activities for the prediction and early detection of exacerbations and life-threatening events, monitoring during the home treatment of mild exacerbations, monitoring oxygen therapy applications, and monitoring exercise. We also present and discuss the current approaches to decision support at remote locations and list the normal and pathological values/ranges for all the relevant physiological parameters. The paper concludes with our insights into the future developments and remaining challenges for improvements to continuous remote monitoring systems.
Wu et al (2018) [Feasibility Study] Feasibility of Using a Smartwatch to Intensively Monitor Patients With Chronic Obstructive Pulmonary Disease: Prospective Cohort Study
Background: Acute exacerbations of chronic obstructive pulmonary disease (COPD) are associated with accelerated decline in lung function, diminished quality of life, and higher mortality. Proactively monitoring patients for early signs of an exacerbation and treating them early could prevent these outcomes. The emergence of affordable wearable technology allows for nearly continuous monitoring of heart rate and physical activity as well as recording of audio which can detect features such as coughing. These signals may be able to be used with predictive analytics to detect early exacerbations. Prior to full development, however, it is important to determine the feasibility of using wearable devices such as smartwatches to intensively monitor patients with COPD.
Objective: We conducted a feasibility study to determine if patients with COPD would wear and maintain a smartwatch consistently and whether they would reliably collect and transmit sensor data.
Methods: Patients with COPD were recruited from 3 hospitals and were provided with a smartwatch that recorded audio, heart rate, and accelerations. They were asked to wear and charge it daily for 90 days. They were also asked to complete a daily symptom diary. At the end of the study period, participants were asked what would motivate them to regularly use a wearable for monitoring of their COPD.
Results: Of 28 patients enrolled, 16 participants completed the full 90 days. The average age of participants was 68.5 years, and 36% (10/28) were women. Survey, heart rate, and activity data were available for an average of 64.5, 65.1, and 60.2 days respectively. Technical issues caused heart rate and activity data to be unavailable for approximately 13 and 17 days, respectively. Feedback provided by participants indicated that they wanted to actively engage with the smartwatch and receive feedback about their activity, heart rate, and how to better manage their COPD.
Conclusions: Some patients with COPD will wear and maintain smartwatches that passively monitor audio, heart rate, and physical activity, and wearables were able to reliably capture near-continuous patient data. Further work is necessary to increase acceptability and improve the patient experience.
Crooks et al (2017) [Observational Study] Continuous Cough Monitoring Using Ambient Sound Recording During Convalescence From a COPD Exacerbation
Purpose: Cough is common in chronic obstructive pulmonary disease (COPD) and is associated with frequent exacerbations and increased mortality. Cough increases during acute exacerbations (AE-COPD), representing a possible metric of clinical deterioration. Conventional cough monitors accurately report cough counts over short time periods. We describe a novel monitoring system which we used to record cough continuously for up to 45 days during AE-COPD convalescence.
Methods: This is a longitudinal, observational study of cough monitoring in AE-COPD patients discharged from a single teaching hospital. Ambient sound was recorded from two sites in the domestic environment and analysed using novel cough classifier software. For comparison, the validated hybrid HACC/LCM cough monitoring system was used on days 1, 5, 20 and 45. Patients were asked to record symptoms daily using diaries.
Results: Cough monitoring data were available for 16 subjects with a total of 568 monitored days. Daily cough count fell significantly from mean ± SEM 272.7 ± 54.5 on day 1 to 110.9 ± 26.3 on day 9 (p < 0.01) before plateauing. The absolute cough count detected by the continuous monitoring system was significantly lower than detected by the hybrid HACC/LCM system but normalised counts strongly correlated (r = 0.88, p < 0.01) demonstrating an ability to detect trends. Objective cough count and subjective cough scores modestly correlated (r = 0.46).
Conclusions: Cough frequency declines significantly following AE-COPD and the reducing trend can be detected using continuous ambient sound recording and novel cough classifier software. Objective measurement of cough frequency has the potential to enhance our ability to monitor the clinical state in patients with COPD.
Background: The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease (COPD) is unsustainable. Health care organizations are focusing on ways to support self-management and prevent hospital admissions, including telehealth-monitoring services capturing physiological and health status data. This paper reports on data captured during a pilot randomized controlled trial of telehealth-supported care within a community-based service for patients discharged from hospital following an exacerbation of their COPD.
Objective: The aim was to undertake the first analysis of system data to determine whether telehealth monitoring can identify an exacerbation of COPD, providing clinicians with an opportunity to intervene with timely treatment and prevent hospital readmission.
Methods: A total of 23 participants received a telehealth-supported intervention. This paper reports on the analysis of data from a telehealth monitoring system that captured data from two sources: 1. data uploaded both manually and using Bluetooth peripheral devices by the 23 participants; and 2. clinical records entered as nursing notes by the clinicians. Rules embedded in the telehealth monitoring system triggered system alerts to be reviewed by remote clinicians who determined whether clinical intervention was required. We also analyzed data on the frequency and length of hospital admissions, frequency of hospital Accident and Emergency visits that did not lead to hospital admission, and frequency and type of community health care service contacts-other than the COPD discharge service-for all participants for the duration of the intervention and 6 months postintervention.
Results: Patients generated 512 alerts, 451 of which occurred during the first 42 days that all participants used the equipment. Patients generated fewer alerts over time with typically seven alerts per day within the first 10 days and four alerts per day thereafter. They also had three times more days without alerts than with alerts. Alerts were most commonly triggered by reports of being more tired, having difficulty with self-care, and blood pressure being out of range. During the 8-week intervention, and for 6-month follow-up, eight of the 23 patients were hospitalized. Hospital readmission rates (2/23, 9%) in the first 28 days of service were lower than the 20% UK norm.
Conclusions: It seems that the clinical team can identify exacerbations based on both an increase in alerts and the types of system-generated alerts as evidenced by their efforts to provided treatment interventions. There was some indication that telehealth monitoring potentially delayed hospitalizations until after patients had been discharged from the service. We suggest that telehealth-supported care can fulfill an important role in enabling patients with COPD to better manage their condition and remain out of hospital, but adequate resourcing and timely response to alerts is a critical factor in supporting patients to remain at home.
Merone et al (2017) [Report] A Decision Support System for Tele-Monitoring COPD-Related Worrisome Events
Chronic Obstructive Pulmonary Disease (COPD) is a preventable, treatable, and slowly progressive disease, whose course is aggravated by a periodic worsening of symptoms and lung function lasting for several days. The development of home telemonitoring systems has made possible to collect symptoms and physiological data in electronic records, boosting the development of decision support systems (DSSs). Current DSSs work with physiological measurements collected by means of several measuring and communication devices as well as with symptoms gathered by questionnaires submitted to COPD subjects. However, this contrasts with the advices provided by the World Health Organization and the Global initiative for chronic Obstructive Lung Disease that recommend to avoid invasive or complex daily measurements. ReportFor these reasons this manuscript presents a DSS detecting the onset of worrisome events in COPD subjects. It uses the hearth rate and the oxygen saturation, which can be collected via a pulse oximeter. The DSS consists in a binary finite state machine, whose training stage allows a subject specific personalization of the predictive model, triggering warnings, and alarms as the health status evolves over time. The experiments on data collected from 22 COPD patients tele-monitored at home for six months show that the system recognition performance is better than the one achieved by medical experts. Furthermore, the support offered by the system in the decision-making process allows to increase the agreement between the specialists, largely impacting the recognition of the worrisome events.
Rubio et al (2017) [Observational Study] Home Monitoring of Breathing Rate in People With Chronic Obstructive Pulmonary Disease: Observational Study of Feasibility, Acceptability, and Change After Exacerbation
Telehealth programs to promote early identification and timely self-management of acute exacerbations of chronic obstructive pulmonary diseases (AECOPDs) have yielded disappointing results, in part, because parameters monitored [symptoms, pulse oximetry, and spirometry] are weak predictors of exacerbations.
Purpose: Breathing rate (BR) rises during AECOPD and may be a promising predictor. Devices suitable for home use to measure BR have recently become available, but their accuracy, acceptability, and ability to detect changes in people with COPD is not known.
Patients and methods: We compared five BR monitors, which used different monitoring technologies, with a gold standard [Oxycon Mobile®; CareFusion®, a subsidiary of Becton Dickinson, San Diego, CA, USA]. The monitors were validated in 21 stable COPD patients during a 57-min “activities of daily living protocol” in a laboratory setting. The two best performing monitors were then tested in a 14-day trial in a home setting in 23 stable COPD patients to determine patient acceptability and reliability of signal. Acceptability was explored in qualitative interviews. The better performing monitor was then given to 18 patients recruited during an AECOPD who wore the monitor to observe BR during the recovery phase of an AECOPD.
Results: While two monitors demonstrated acceptable accuracy compared with the gold standard, some participants found them intrusive particularly when ill with an exacerbation, limiting their potential utility in acute situations. A reduction in resting BR during the recovery from an AECOPD was observed in some, but not in all participants and there was considerable day-to-day individual variation.
Conclusion: Resting BR shows some promise in identifying exacerbations; however, further prospective study to assess this is required.
Talboom-Kamp et al (2017) [Cohort Study] The Effect of Integration of Self-Management Web Platforms on Health Status in Chronic Obstructive Pulmonary Disease Management in Primary Care (e-Vita Study): Interrupted Time Series Design
Background: Worldwide nearly 3 million people die from chronic obstructive pulmonary disease (COPD) every year. Integrated disease management (IDM) improves quality of life for COPD patients and can reduce hospitalization. Self-management of COPD through eHealth is an effective method to improve IDM and clinical outcomes.
Objectives: The objective of this implementation study was to investigate the effect of 3 chronic obstructive pulmonary disease eHealth programs applied in primary care on health status. The e-Vita COPD study compares different levels of integration of Web-based self-management platforms in IDM in 3 primary care settings. Patient health status is examined using the Clinical COPD Questionnaire (CCQ).
Methods: The parallel cohort design includes 3 levels of integration in IDM [groups 1, 2, 3] and randomization of 2 levels of personal assistance for patients [group A, high assistance, group B, low assistance]. Interrupted time series (ITS) design was used to collect CCQ data at multiple time points before and after intervention, and multilevel linear regression modeling was used to analyze CCQ data.
Results: Of the 702 invited patients, 215 (30.6%) registered to a platform. Of these, 82 participated in group 1 (high integration IDM), 36 in group 1A (high assistance), and 46 in group 1B (low assistance); 96 participated in group 2 (medium integration IDM), 44 in group 2A (high assistance) and 52 in group 2B (low assistance); also, 37 participated in group 3 (no integration IDM). In the total group, no significant difference was found in change in CCQ trend (P=.334) before (-0.47% per month) and after the intervention (-0.084% per month). Also, no significant difference was found in CCQ changes before versus after the intervention between the groups with high versus low personal assistance. In all subgroups, there was no significant change in the CCQ trend before and after the intervention (group 1A, P=.237; 1B, P=.991; 2A, P=.120; 2B, P=.166; 3, P=.945).
Conclusions: The e-Vita eHealth-supported COPD programs had no beneficial impact on the health status of COPD patients. Also, no differences were found between the patient groups receiving different levels of personal assistance.
Thomas et al (2017) [Pilot Study] Inhaler Training Delivered by Internet-Based Home Videoconferencing Improves Technique and Quality of Life
Background: COPD is common, and inhaled medications can reduce the risk of exacerbations. Incorrect inhaler use is also common and may lead to worse symptoms and increased exacerbations. We examined whether inhaler training could be delivered using Internet-based home videoconferencing and its effect on inhaler technique, self-efficacy, quality of life, and adherence.
Methods: In this pre-post pilot study, participants with COPD had 3 monthly Internet-based home videoconference visits with a pharmacist who provided inhaler training using teach-to-goal methodology. Participants completed mailed questionnaires to ascertain COPD severity, self-efficacy, health literacy, quality of life, adherence, and satisfaction with the intervention.
Results: A total of 41 participants completed at least one, and 38 completed all 3 home videoconference visits. During each visit, technique improved for all inhalers, with significant improvements for the albuterol metered-dose inhaler, budesonide/formoterol metered-dose inhaler, and tiotropium dry powder inhaler. Improved technique was sustained for nearly all inhalers at 1 and 2 months. Quality of life measured with the Chronic Respiratory Questionnaire improved following the training: dyspnea (+0.3 points, P = .01), fatigue (+0.6 points, P < .001), emotional function (+0.5 points, P = .001), and mastery (+0.7 points, P < .001). Coping skills measured with the Seattle Obstructive Lung Disease Questionnaire improved (+9.9 points, P = .003). Participants reported increased confidence in inhaler use; for example, mean self-efficacy for using albuterol increased 3 points (P < .001). Inhaler adherence improved significantly after the intervention from 1.6 at the initial visit to 1.1 at month 2 (P = .045). The pharmacist reported technical issues in 64% of visits.
Conclusions: Inhaler training using teach-to-goal methodology delivered by home videoconference is a promising means to provide training to patients with COPD that can improve technique, quality of life, self-efficacy, and adherence.
Tillis et al (2017) [Feasibilty Study] Implementation of Activity Sensor Equipment in the Homes of Chronic Obstructive Pulmonary Disease Patients
Introduction: Telemedicine care models for managing advanced chronic obstructive pulmonary disease (COPD) may benefit from the addition of motion sensing, spirometry, and tablet-based symptom diary tracking.
Methods: We conducted a feasibility study of telemedicine in the home setting using multiple activity sensor monitoring equipment. Deployment and monitoring were supported by home health nurses with technical advice from the equipment makers as needed. Data analytics for motion sensing was provided by the research sponsor, but was not used for care decisions. On study intake, a health risk assessment, Quality of Life (SF-36) survey, and the St. George Respiratory Questionnaire were administered to assess patients’ self-perception of quality of life, activities of daily life function, and difficulty living with COPD.
Results: Twenty-eight patients were enrolled and data were gathered for a minimum of 6 months and maximum of 9 months. The researchers demonstrated that augmentation of traditional telemedicine methods with motion sensing, spirometry, and symptom diaries appears feasible. The technical, process, logistics barriers, and solutions required for system deployment are described. The researchers demonstrated that augmentation of traditional telemedicine methods with motion sensing, spirometry, and symptom diaries appears feasible.
Conclusions: Further exploration will be needed to determine the value of this information in preventing outcomes relevant to patients.
Zanaboni et al (2017) [Pilot Study] Long-term Exercise Maintenance in COPD via Telerehabilitation: A Two-Year Pilot Study
Introduction: Pulmonary rehabilitation (PR) is an integral part of the management of chronic obstructive pulmonary disease (COPD). However, many patients do not access or complete PR, and long-term exercise maintenance has been difficult to achieve after PR. This study aimed to investigate feasibility, long-term exercise maintenance, clinical effects, quality of life and use of hospital resources of a telerehabilitation intervention. Methods: Ten patients with COPD were offered a two-year follow-up via telerehabilitation after attending PR. The intervention consisted of home exercise, telemonitoring and self-management via a webpage combined with weekly videoconferencing sessions. Equipment included a treadmill, a pulse oximeter and a tablet. Data collected at baseline, one year and two years were six-minute walking distance (6MWD), COPD assessment test (CAT), EuroQol 5 dimensions (EQ-5D), hospitalisations and outpatient visits.
Results: No dropout occurred. Physical performance, lung capacity, health status and quality of life were all maintained at two years. At one year, 6MWD improved by a mean of 40 metres from baseline, CAT decreased by four points and EQ visual analogue scale (EQ VAS) improved by 15.6 points.
Discussion: Long-term exercise maintenance in COPD via telerehabilitation is feasible. Results are encouraging and suggest that telerehabilitation can prevent deterioration and improve physical performance, health status and quality of life.
Esteban et al (2016) [Observational Study] Outcomes of a Telemonitoring-Based Program (telEPOC) in Frequently Hospitalized COPD Patients
Background: The increasing prevalence of chronic diseases requires changes in health care delivery. In COPD, telemedicine appears to be a useful tool. Our objective was to evaluate the efficacy (in improving health care-resource use and clinical outcomes) of a telemonitoring-based program (telEPOC) in COPD patients with frequent hospitalizations.
Materials and methods: We conducted a nonrandomized observational study in an intervention cohort of 119 patients (Galdakao-Usansolo Hospital) and a control cohort of 78 patients (Cruces Hospital), followed up for 2 years. The inclusion criteria were two or more hospital admissions in the previous year or three or more admissions in the previous 2 years. The intervention group received telemonitoring plus education and controls usual care.
Results: Most participants were men (13% women), and the sample had a mean age of 70 years, forced expiratory volume in 1 second of 45%, Charlson comorbidity index score of 3.5, and BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index score of 4.1. In multivariate analysis, the intervention was independently related to lower rates of hospital admission (odds ratio [OR] 0.38, 95% confidence interval [CI] 0.27-0.54; P<0.0001), emergency department attendance (OR 0.56, 95% CI 0.35-0.92; P<0.02), and 30-day readmission (OR 0.46, 95% CI 0.29-0.74; P<0.001), as well as cumulative length of stay (OR 0.58, 95% CI 0.46-0.73; P<0.0001). The intervention was independently related to changes in several clinical variables during the 2-year follow-up.
Conclusion: An intervention including telemonitoring and education was able to reduce the health care-resource use and stabilize the clinical condition of frequently admitted COPD patients.
Hamad et al (2016) [Observational Study] The Value of Telehealth in the Early Detection of Chronic Obstructive Pulmonary Disease Exacerbations: A Prospective Observational Study
We aim to establish the value of telemonitoring in the early detection of chronic obstructive pulmonary disease exacerbations. We followed up patients undergoing chronic obstructive pulmonary disease telemonitoring for 4 months. We studied changes in the telemonitored data in the week prior to admission or to community chronic obstructive pulmonary disease exacerbation. A total of 183 patients were studied. In all, 30 chronic obstructive pulmonary disease-related hospital admissions and 68 chronic obstructive pulmonary disease community exacerbations were recorded. Changes in telehealth parameters occurred in 80 per cent (24/30) of admissions and 82 per cent (56/68) of community exacerbations. Although changes in telehealth data occurred in the majority of exacerbations, most individual symptoms was present in less than half the exacerbations and almost 20 per cent of exacerbations were not preceded by any change in telemonitoring data. Cough created significantly more alerts by those treated in the community (p = 0.008), whereas a drop in oxygen saturation created significantly more alerts pre-hospitalisation (p = 0.049). We conclude that further work is required to develop methods of identifying impending chronic obstructive pulmonary disease exacerbations with greater sensitivity and specificity.
Huygens et al (2016) [Qualitative Study] Expectations and Needs of Patients With a Chronic Disease Toward Self-Management and eHealth for Self-Management Purposes
Background: Self-management is considered as an essential component of chronic care by primary care professionals. eHealth is expected to play an important role in supporting patients in their self-management. For effective implementation of eHealth it is important to investigate patients’ expectations and needs regarding self-management and eHealth. The objectives of this study are to investigate expectations and needs of people with a chronic condition regarding self-management and eHealth for self-management purposes, their willingness to use eHealth, and possible differences between patient groups regarding these topics.
Methods: Five focus groups with people with diabetes (n = 14), COPD (n = 9), and a cardiovascular condition (n = 7) were conducted in this qualitative research. Separate focus groups were organized based on patients’ chronic condition. The following themes were discussed: 1. the impact of the chronic disease on patients’ daily life; 2. their opinions and needs regarding self-management; and 3. their expectations and needs regarding, and willingness to use, eHealth for self-management purposes. A conventional content analysis approach was used for coding.
Results: Patient groups seem to differ in expectations and needs regarding self-management and eHealth for self-management purposes. People with diabetes reported most needs and benefits regarding self-management and were most willing to use eHealth, followed by the COPD group. People with a cardiovascular condition mentioned having fewer needs for self-management support, because their disease had little impact on their life. In all patient groups it was reported that the patient, not the care professional, should choose whether or not to use eHealth. Moreover, participants reported that eHealth should not replace, but complement personal care. Many participants reported expecting feelings of anxiety by doing measurement themselves and uncertainty about follow-up of deviant data of measurements. In addition, many participants worried about the implementation of eHealth being a consequence of budget cuts in care.
Conclusion: This study suggests that aspects of eHealth, and the way in which it should be implemented, should be tailored to the patient. Patients’ expected benefits of using eHealth to support self-management and their perceived controllability over their disease seem to play an important role in patients’ willingness to use eHealth for self-management purposes.
McNamara et al (2016) [Prospective Study] Measurement of Daily Physical Activity Using the SenseWear Armband: Compliance, Comfort, Adverse Side Effects and Usability
Little is known about the acceptability of wearing physical activity-monitoring devices. This study aimed to examine the compliance, comfort, incidence of adverse side effects, and usability when wearing the SenseWear Armband (SWA) for daily physical activity assessment. In a prospective study, 314 participants (252 people with COPD, 36 people with a dust-related respiratory disease and 26 healthy age-matched people) completed a purpose-designed questionnaire following a 7-day period of wearing the SWA. Compliance, comfort levels during the day and night, adverse side effects and ease of using the device were recorded. Non-compliance with wearing the SWA over 7 days was 8%. The main reasons for removing the device were adverse side effects and discomfort. The SWA comfort level during the day was rated by 11% of participants as uncomfortable/very uncomfortable, with higher levels of discomfort reported during the night (16%). Nearly half of the participants (46%) experienced at least one adverse skin irritation side effect from wearing the SWA including itchiness, skin irritation and rashes, and/or bruising. Compliance with wearing the SWA for measurement of daily physical activity was found to be good, despite reports of discomfort and a high incidence of adverse side effects.
Fernandez-Granero et al (2015) [Pilot Study] Computerised Analysis of Telemonitored Respiratory Sounds for Predicting Acute Exacerbations of COPD
Chronic obstructive pulmonary disease (COPD) is one of the commonest causes of death in the world and poses a substantial burden on healthcare systems and patients’ quality of life. The largest component of the related healthcare costs is attributable to admissions due to acute exacerbation (AECOPD). The evidence that might support the effectiveness of the telemonitoring interventions in COPD is limited partially due to the lack of useful predictors for the early detection of AECOPD. Electronic stethoscopes and computerised analyses of respiratory sounds (CARS) techniques provide an opportunity for substantial improvement in the management of respiratory diseases. This exploratory study aimed to evaluate the feasibility of using: (a) a respiratory sensor embedded in a self-tailored housing for ageing users; (b) a telehealth framework; (c) CARS and (d) machine learning techniques for the remote early detection of the AECOPD. In a 6-month pilot study, 16 patients with COPD were equipped with a home base-station and a sensor to daily record their respiratory sounds. Principal component analysis (PCA) and a support vector machine (SVM) classifier was designed to predict AECOPD. 75.8% exacerbations were early detected with an average of 5 ± 1.9 days in advance at medical attention. The proposed method could provide support to patients, physicians and healthcare systems.
Background: The use of telehealth technologies to remotely monitor patients suffering chronic diseases may enable preemptive treatment of worsening health conditions before a significant deterioration in the subject’s health status occurs, requiring hospital admission.
Objective: The objective of this study was to develop and validate a classification algorithm for the early identification of patients, with a background of chronic obstructive pulmonary disease (COPD), who appear to be at high risk of an imminent exacerbation event. The algorithm attempts to predict the patient’s condition one day in advance, based on a comparison of their current physiological measurements against the distribution of their measurements over the previous month.
Method: The proposed algorithm, which uses a classification and regression tree (CART), has been validated using telehealth measurement data recorded from patients with moderate/severe COPD living at home. The data were collected from February 2007 to January 2008, using a telehealth home monitoring unit.
Results: The CART algorithm can classify home telehealth measurement data into either a low risk or high risk category with 71.8% accuracy, 80.4% specificity and 61.1% sensitivity. The algorithm was able to detect a ‘high risk’ condition one day prior to patients actually being observed as having a worsening in their COPD condition, as defined by symptom and medication records.
Conclusion: The CART analyses have shown that features extracted from three types of physiological measurements; forced expiratory volume in 1s (FEV1), arterial oxygen saturation (SPO2) and weight have the most predictive power in stratifying the patients condition. This CART algorithm for early detection could trigger the initiation of timely treatment, thereby potentially reducing exacerbation severity and recovery time and improving the patient’s health. This study highlights the potential usefulness of automated analysis of home telehealth data in the early detection of exacerbation events among COPD patients.
Paneroni et al (2015) [Feasibility Study] Is Telerehabilitation a Safe and Viable Option for Patients With COPD? A Feasibility Study
In patients with COPD non-naïve to rehabilitation we tested the feasibility, adherence and satisfaction of a home-based reinforcement telerehabilitation program (TRP). Outcomes were compared with a standard outpatient rehabilitation program (ORP). Then 18 TRP patients underwent 28 sessions of strength exercises (60 min) and cycle training (40 min) using a satellite platform provided telemonitoring, tele-prescription, video-assistance and phone-calls, patients were equipped with an oximeter, steps-counter, bicycle, remote control and interactive TV software. 18 matched ORP, retrospectively identified from our hospital ORP database, were used as controls. At baseline and end of program, the 6-min walking test (6MWT), Medical Research Council (MRC) scale and Saint George’s Respiratory Questionnaire (SGRQ) were administered. In TRP only, we assessed platform use, incremental exercise, steps walked/day and patient satisfaction. TRP patients completed all sessions without side effects, used the remote control 1,394 ± 2,329 times being in the 84% of the cases satisfied with the service. In 22% of the cases patients found the technology unfriendly. Each health-professional performed 46 ± 65 actions, 14.6 ± 2.12 phone calls and 1 ± 1.67 videoconference sessions per patient. TRP patients increased physical activity (3,412 vs. 1,863 steps/day, p = 0.0002). Both programs produced significant (all, p < 0.01) gains in 6MWT [meters, TRP +34.22 ± 50.79; ORP +33.61 ± 39.25], dyspnea [TRP – 0.72 ± 0.89; ORP – 0.94 ± 0.53] and SGRQ [TRP – 6.9 ± 9.96, ORP – 9.9 ± 12.92] without between-group differences. In conclusion, TRP is feasible and well accepted by patients, although sometimes technology was perceived as difficult. It seems to improve walking capacity, dyspnea, quality of life and daily physical activity. Future RCTs will demonstrate cost-effectiveness.
Sanchez-Morillo et al (2015) [Pilot Study] Detecting COPD Exacerbations Early Using Daily Telemonitoring of Symptoms and K-Means Clustering: A Pilot Study
COPD places an enormous burden on the healthcare systems and causes diminished health-related quality of life. The highest proportion of human and economic cost is associated with admissions for acute exacerbation of respiratory symptoms (AECOPD). Since prompt detection and treatment of exacerbations may improve outcomes, early detection of AECOPD is a critical issue. This pilot study was aimed to determine whether a mobile health system could enable early detection of AECOPD on a day-to-day basis. A novel electronic questionnaire for the early detection of COPD exacerbations was evaluated during a 6-months field trial in a group of 16 patients. Pattern recognition techniques were applied. A k-means clustering algorithm was trained and validated, and its accuracy in detecting AECOPD was assessed. Sensitivity and specificity were 74.6 and 89.7 %, respectively, and area under the receiver operating characteristic curve was 0.84. 31 out of 33 AECOPD were early identified with an average of 4.5 ± 2.1 days prior to the onset of the exacerbation that was considered the day of medical attendance. Based on the findings of this preliminary pilot study, the proposed electronic questionnaire and the applied methodology could help to early detect COPD exacerbations on a day-to-day basis and therefore could provide support to patients and physicians.
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