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Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial.

ABSTRACT: Pulmonary rehabilitation is widely advocated for people with chronic obstructive pulmonary disease (COPD) to improve exercise capacity, symptoms and quality of life, however only a minority of individuals with COPD are able to participate. Travel and transport are frequently cited as barriers to uptake of centre-based programs. Other models of pulmonary rehabilitation, including home-based programs, have been proposed in order to improve access to this important treatment. Previous studies of home-based pulmonary rehabilitation in COPD have demonstrated improvement in exercise capacity and quality of life, but not all elements of the program were conducted in the home environment. It is uncertain whether a pulmonary rehabilitation program delivered in its entirety at home is cost effective and equally capable of producing benefits in exercise capacity, symptoms and quality of life as a hospital-based program. The aim of this study is to compare the costs and benefits of home-based and hospital-based pulmonary rehabilitation for people with COPD.This randomised, controlled, equivalence trial conducted at two centres will recruit 166 individuals with spirometrically confirmed COPD. Participants will be randomly allocated to hospital-based or home-based pulmonary rehabilitation. Hospital programs will follow the traditional outpatient model consisting of twice weekly supervised exercise training and education for eight weeks. Home-based programs will involve one home visit followed by seven weekly telephone calls, using a motivational interviewing approach to enhance exercise participation and facilitate self management. The primary outcome is change in 6-minute walk distance immediately following intervention. Measurements of exercise capacity, physical activity, symptoms and quality of life will be taken at baseline, immediately following the intervention and at 12 months, by a blinded assessor. Completion rates will be compared between programs. Direct healthcare costs and indirect (patient-related) costs will be measured to compare the cost-effectiveness of each program.This trial will identify whether home-based pulmonary rehabilitation can deliver equivalent benefits to centre-based pulmonary rehabilitation in a cost effective manner. The results of this study will contribute new knowledge regarding alternative models of pulmonary rehabilitation and will inform pulmonary rehabilitation guidelines for COPD.

SUBMITTER: Holland AE

PROVIDER: S-EPMC3844512 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial.

Holland Anne E AE Mahal Ajay A Hill Catherine J CJ Lee Annemarie L AL Burge Angela T AT Moore Rosemary R Nicolson Caroline C O'Halloran Paul P Cox Narelle S NS Lahham Aroub A Ndongo Rebecca R Bell Emily E McDonald Christine F CF

BMC pulmonary medicine 20130908

<h4>Background</h4>Pulmonary rehabilitation is widely advocated for people with chronic obstructive pulmonary disease (COPD) to improve exercise capacity, symptoms and quality of life, however only a minority of individuals with COPD are able to participate. Travel and transport are frequently cited as barriers to uptake of centre-based programs. Other models of pulmonary rehabilitation, including home-based programs, have been proposed in order to improve access to this important treatment. Pre ...[more]

PMID: 24011178

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Project description:BackgroundSupervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting.MethodsThis multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions.DiscussionThe SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH.Trial registrationISRCTN no. 10608766, prospectively registered on 18th March 2019.

Project description:Purpose:Pulmonary rehabilitation (PR) is a well-established treatment for chronic obstructive pulmonary disease (COPD). The standard protocol for PR requires frequent hospital visits, which can be difficult for patients. We performed this study to assess whether unsupervised home-based PR (HBPR) is effective for patients with COPD. Patients and Methods:After assessing the outcome data, including the results of a COPD assessment test (CAT); the body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index; a spirometry; the modified Medical Research Council (mMRC) dyspnea scale; and the 6-min walking test (6MWT), specialists imparted 1-hour education to patients regarding unsupervised HBPR at the baseline visit. This included methods for breathing, inhaler use, stretching, and exercise. On reviewing diaries after 8 weeks from the first visit, patients who exercised at least thrice per week were classified as the compliant group and the others were categorized as the noncompliant group. Changes in the outcomes were compared between the compliant and noncompliant groups. Results:A total of 41 patients were enrolled in this study; for 8 weeks of unsupervised HBPR, there were significant improvements in CAT scores (-4.62±4.61 vs 2.40±6.73; P=0.002), BODE index (-1.00±1.06 vs -0.20±0.56; P=0.01), and forced expiratory volume in 1 s (0.05±0.19 vs -0.09±0.16; P=0.02) among patients in the compliant group, compared with the noncompliant group. Moreover, their CAT (16.46±7.80 vs 11.85±7.23; P=0.03) and mMRC scores (2.54±0.76 vs 1.81±0.63; P=0.001) improved significantly after 8 weeks, compared with those at baseline. On the other hand, patients in the noncompliant group showed no significant improvement in any of the outcomes. Conclusion:In this study, compliant patients with unsupervised HBPR achieved favorable outcomes in 8 weeks. Thus, we recommend unsupervised HBPR for patients with COPD, even when regular hospital visits for PR are not possible. Trial Registration:NCT03754881.

Project description: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.

Project description:BackgroundAlthough pulmonary rehabilitation (PR) is considered a key component in managing chronic obstructive pulmonary disease (COPD) patients, uptake remains suboptimal. This systematic review aimed to determine the effectiveness of home-based PR (HBPR) programs for COPD patients.MethodsA systematic review of scholarly literature published within the last 10 years from the conception of this project was conducted using internationally recognized guidelines. Search strategies were applied to electronic databases and clinical trial registries through March 2020 and updated in November 2021 to identify studies comparing HBPR with 'usual care' or outpatient pulmonary rehabilitation (OPR). To critically appraise randomized studies, the Cochrane Collaboration risk of bias tool (ROB) was used. The quality of non-randomized studies was evaluated using the ACROBAT-NRSI tool. The quality of evidence relating to key outcomes was assessed using Grading of Recommendations, Assessment, Development and Evaluations (GRADE) on health-related quality of life (HRQoL), exacerbation frequencies, COPD-related hospital admissions, and program adherence. Three independent reviewers assessed methodologic quality and reviewed the studies.ResultsTwelve randomized controlled trials (RCTs) and 2 comparative observational studies were included. While considerable evidence relating to the effectiveness of HBPR programs for COPD patients exist, overall quality is low. There were no differences between HBPR and OPR in terms of safety, HRQoL, functional exercise capacity and health care resource utilization. Compared to usual care, functional exercise capacity seemed to significantly improve after HBPR. While patient compliance with HBPR is good, two factors appeared to increase the 'risk' of non-compliance: expectations of patients to 1) complete daily diaries/activity logs and 2) engage in solely unsupervised exercise sessions.ConclusionThe overall quality for most outcomes was low to very low; however, HBPR seems to offer comparable short-term benefits to OPR.

Project description:This paper presents a rapid review of the literature for the components, benefits, barriers, and facilitators of pulmonary rehabilitation for chronic obstructive pulmonary disease (COPD) people in-home and community-based settings. seventy-six studies were included: 57 home-based pulmonary rehabilitation (HBPR) studies and 19 community-based pulmonary rehabilitation (CBPR) studies. The benefits of HBPR on exercise capacity and health-related quality of life were observed in one-group studies, studies comparing HBPR to usual care, and studies comparing to hospital-based pulmonary rehabilitation, although the benefits were less pronounced in the latter. HBPR reduced hospital admissions compared to usual care and was more cost-effective than hospital pulmonary rehabilitation. Most HBPRs were designed with low-density or customized equipment, are minimally supervised, and have a low intensity of training. Although the HBPR has flexibility and no travel burden, participants with severe disease, physical frailty, and complex comorbidities had barriers to complying with HBPR. The telerehabilitation program, a facilitator for HBPR, is feasible and safe. CBPR was offered in-person supervision, despite being limited to physical therapists in most studies. Benefits in exercise capacity were shown in almost all studies, but the improvement in health-related quality of life was controversial. Patients reported the benefits that facilities where they attended the CBPR including social support and the presence of an instructor. They also reported barriers, such as poor physical condition, transport difficulties, and family commitments. Despite the minimal infrastructure offered, HBPR and CBPR are feasible, safe, and provide clinical benefits to patients with COPD. Home and community settings are excellent opportunities to expand the offer of pulmonary rehabilitation programs, as long as they follow protocols that ensure quality and safety following current guidelines.

Dataset Information

Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial.

Publications

Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial.

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