An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD
NCT04217330 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 490
Last updated 2025-07-08
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.
Conditions
Interventions
- BEHAVIORAL
-
Choice 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.
- BEHAVIORAL
-
Centre-based pulmonary rehabilitation
Participants will be offered a traditional centre-based pulmonary rehabilitation program
Sponsors & Collaborators
-
Institute for Breathing and Sleep, Australia
collaborator OTHER - collaborator OTHER
-
La Trobe University
collaborator OTHER -
Thoracic Society of Australia and New Zealand
collaborator UNKNOWN -
Lung Foundation Australia
collaborator UNKNOWN - lead OTHER
Principal Investigators
-
Anne Holland · Monash University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-01
- Primary Completion
- 2026-02-28
- Completion
- 2026-02-28
Countries
- Australia
Study Locations
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