An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD

Not Applicable

Active, not recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• 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

Study Timeline

• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2020-01-01
• Study First Posted: 2020-01-03
• Study Start: 2021-03-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-02
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

Not provided

Exclusion Criteria

• Attended pulmonary rehabilitation within 1 year
• Comorbidities which preclude exercise training.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

Mount Druitt Hospital; 🇦🇺 Sydney, New South Wales, Australia

Prince of Wales Hospital; 🇦🇺 Sydney, New South Wales, Australia

Westmead Hospital; 🇦🇺 Sydney, New South Wales, Australia

Top End Health Service; 🇦🇺 Darwin, Northern Territory, 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

Peninsula Health; 🇦🇺 Melbourne, Victoria, Australia

St John of God Frankston Rehabilitation; 🇦🇺 Melbourne, Victoria, Australia

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