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Clinical Trials in Australia / NCT04217330
Active, not recruiting Not applicable

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

NCT04217330 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2021-03-01
Last updated
2025-07-08

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

Choice of home-based or centre-based pulmonary rehabilitationCentre-based pulmonary rehabilitation

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.

Centre-based pulmonary rehabilitation: Participants will be offered a traditional centre-based pulmonary rehabilitation program

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Royal Prince Alfred Hospital Sydney New South Wales
Mount Druitt Hospital Sydney New South Wales
Prince of Wales Hospital Sydney New South Wales
Westmead Hospital Sydney New South Wales
Top End Health Service Darwin Northern Territory
Prince Charles Hospital Brisbane Queensland
Central Adelaide Local Health Network Adelaide South Australia
Southern Adelaide Local Health Network Adelaide South Australia
Peninsula Health Melbourne Victoria
St John of God Frankston Rehabilitation Melbourne Victoria
Western Health Melbourne Victoria

More Monash University trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04217330 on ClinicalTrials.gov ↗ ← All trials in Australia