Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Pulmonary rehabilitation, Implementation, COPD
Brief summary
People with chronic obstructive pulmonary disease (COPD) experience distressing breathlessness and high health care utilisation. There is compelling evidence that pulmonary rehabilitation improves symptoms and reduces hospitalisation, but is delivered to \<10% of patients who would benefit. The investigators developed a low cost model of pulmonary rehabilitation that can be delivered entirely at home. The HomeBase model had equivalent outcomes to centre-based pulmonary rehabilitation in a phase II efficacy trial, with higher completion rates. The investigators hypothesise that a patient centred model offering a choice between home or centre-based pulmonary rehabilitation may increase program completion rates, with improved outcomes for patients and the health system. This is a cluster randomised implementation trial investigating whether offering a choice of home or centre-based pulmonary rehabilitation can reduce hospitalisation, improve pulmonary rehabilitation completion and enhance patient outcomes in people with COPD. 14 pulmonary rehabilitation programs located across Australia will each recruit 35 people with COPD. Intervention centres: People with COPD will be offered the choice of centre-based pulmonary rehabilitation or the HomeBase model. Comparison centres: Only the existing centre-based model will be offered. The primary outcome is all cause, non-elective hospitalisation at 12 months. Other outcomes are symptoms, exercise capacity and quality of life at 8 weeks and 12 months; and health care costs at 12 months for full economic evaluation.
Interventions
BEHAVIORALChoice of home-based or centre-based pulmonary rehabilitation
Participants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program.
BEHAVIORALCentre-based pulmonary rehabilitation
Participants will be offered a traditional centre-based pulmonary rehabilitation program
Sponsors
Institute for Breathing and Sleep, Australia
University of Melbourne
La Trobe University
Thoracic Society of Australia and New Zealand
Lung Foundation Australia
Monash University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be informed that the trial is assessing the impact of pulmonary rehabilitation models on patient and health system outcomes, but not the specific nature of the models of interest, or the intervention group to which their site has been allocated. Assessors will be blinded to the site allocation.
Intervention model description
Cluster randomized trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
for pulmonary rehabilitation programs: • Outpatient pulmonary rehabilitation programs that admit at least 50 people with COPD each year. Inclusion criteria for participants: * Diagnosis of COPD confirmed on spirometry * Able to read, write and speak English * Able to provide informed consent.
Exclusion criteria
* Attended pulmonary rehabilitation within 1 year * Comorbidities which preclude exercise training.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause, non-elective hospitalisation | 12 months after completing pulmonary rehabilitation | The number of participants hospitalised at least once will be compared between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-minute walk distance | End of rehabilitation and 12 months later | Distance walked in 6 minutes |
| Change in chronic respiratory disease questionnaire total and domain scores | End of rehabilitation and 12 months later | Disease-specific health-related quality of life measure; scores range 1-7, higher scores indicate better health-related quality of life |
| EQ-5D-5L | End of rehabilitation and 12 months later | Generic health-related quality of life measure to inform economic analysis; 5 dimensions each scored 1-5 with lower values indicating better health-related quality of life |
| Change in dyspnoea-12 | End of rehabilitation and 12 months later | Global measure of breathlessness; total scores range from 0 to 36, with higher scores corresponding to greater severity of dyspnoea |
| Change in objectively measured physical activity | End of rehabilitation and 12 months later | Objective measure of physical activity using the actigraph |
| Health care costs | 12 months following pulmonary rehabilitation completion | Health care costs in Australian dollars will be calculated using health care utilisation data including hospitalisation, primary care visits and medication use |
| Program completion | End of rehabilitation | The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions). |
Countries
Australia
Outcome results
None listed