Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program. We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months. If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system

Official Title
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Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Home-based pulmonary rehabilitation
* Behavioral: Hospital-based pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: current or former smokers of at least 10 packet years aged 40 years or over diagnosis of COPD confirmed on spirometry. Exclusion Criteria: previous diagnosis of asthma have attended a pulmonary rehabilitation program in the last two years exacerbation of COPD within the last four weeks have comorbidities which prevent participation in an exercise training program

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based pulmonary rehabilitation<br>Home visit plus 8 weeks of once-weekly telephone calls | Behavioral: Home-based pulmonary rehabilitation<br>* One home visit plus weekly telephone calls for 8 weeks<br>|
| Active Comparator: Hospital-based pulmonary rehabilitation<br>Standard twice-weekly 8-week outpatient pulmonary rehabilitation program | Behavioral: Hospital-based pulmonary rehabilitation<br>* Standard twice-weekly 8-week outpatient pulmonary rehabilitation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-minute walk test | Testing equivalence between groups | Baseline, 8 weeks and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Chronic Respiratory Disease Questionnaire |  | Baseline, 8 weeks and 12 months | 
| Change in Modified Medical Research Council Scale |  | Baseline, 8 weeks and 12 months | 
| Cost-effectiveness |  | 12 months | 
| SF-36 v2 | Contributes to cost effectiveness analysis | Baseline, 8 weeks and 12 months | 
| Program completion rate |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, exercise, rehabilitation, dyspnea, quality of life, economic evaluation