Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, exercise, rehabilitation, dyspnea, quality of life, economic evaluation
Brief summary
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
Interventions
BEHAVIORALHome-based pulmonary rehabilitation
One home visit plus weekly telephone calls for 8 weeks
BEHAVIORALHospital-based pulmonary rehabilitation
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
Sponsors
The Alfred
Austin Health
Monash University
La Trobe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-minute walk test | Baseline, 8 weeks and 12 months | Testing equivalence between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, 8 weeks and 12 months | Contributes to cost effectiveness analysis |
| Program completion rate | 8 weeks | — |
Countries
Australia
Outcome results
None listed