An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Behavioral: Choice of home-based or centre-based pulmonary rehabilitationBehavioral: Centre-based pulmonary rehabilitation
- Registration Number
- NCT04217330
- Lead Sponsor
- Monash University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 490
Not provided
- Attended pulmonary rehabilitation within 1 year
- Comorbidities which preclude exercise training.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Choice of home-based or centre-based pulmonary rehabilitation Pulmonary rehabilitation programs assigned to the intervention group will offer eligible participants the choice of participating in an 8-week program of either home-based pulmonary rehabilitation or traditional centre-based pulmonary rehabilitation. Control Centre-based pulmonary rehabilitation Pulmonary rehabilitation programs assigned to the control group will offer eligible participants the opportunity to participate in an 8-week centre-based pulmonary rehabilitation program, as per current practice.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in 6-minute walk distance End of rehabilitation and 12 months later Distance walked in 6 minutes
Program completion End of rehabilitation The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).
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 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
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
Trial Locations
- Locations (11)
Prince of Wales Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Mount Druitt Hospital
🇦🇺Sydney, New South Wales, Australia
Prince Charles Hospital
🇦🇺Brisbane, Queensland, Australia
Central Adelaide Local Health Network
🇦🇺Adelaide, South Australia, Australia
Southern Adelaide Local Health Network
🇦🇺Adelaide, South Australia, Australia
St John of God Frankston Rehabilitation
🇦🇺Melbourne, Victoria, Australia
Westmead Hospital
🇦🇺Sydney, New South Wales, Australia
Western Health
🇦🇺Melbourne, Victoria, Australia
Top End Health Service
🇦🇺Darwin, Northern Territory, Australia
Peninsula Health
🇦🇺Melbourne, Victoria, Australia