An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD
NCT ID: NCT04217330
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
490 participants
INTERVENTIONAL
2021-03-01
2026-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Assessors will be blinded to the site allocation.
Study Groups
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Intervention
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.
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.
Control
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.
Centre-based pulmonary rehabilitation
Participants will be offered a traditional centre-based pulmonary rehabilitation program
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of COPD confirmed on spirometry
* Able to read, write and speak English
* Able to provide informed consent.
Exclusion Criteria
* Comorbidities which preclude exercise training.
ALL
No
Sponsors
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Institute for Breathing and Sleep, Australia
OTHER
University of Melbourne
OTHER
La Trobe University
OTHER
Thoracic Society of Australia and New Zealand
UNKNOWN
Lung Foundation Australia
UNKNOWN
Monash University
OTHER
Responsible Party
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Anne E Holland PhD, FThorSoc
Professor of Physiotherapy
Principal Investigators
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Anne Holland
Role: PRINCIPAL_INVESTIGATOR
Monash University
Locations
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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
Western Health
Melbourne, Victoria, Australia
Countries
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References
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Cox NS, Holland AE, Jones AW, McDonald CF, O'Halloran P, Mahal A, Hepworth G, Lannin NA. Implementation of offering choice of pulmonary rehabilitation location to people with COPD: a protocol for the process evaluation of a cluster randomised controlled trial. Trials. 2023 Mar 8;24(1):173. doi: 10.1186/s13063-023-07179-2.
Holland AE, Jones AW, Mahal A, Lannin NA, Cox N, Hepworth G, O'Halloran P, McDonald CF. Implementing a choice of pulmonary rehabilitation models in chronic obstructive pulmonary disease (HomeBase2 trial): protocol for a cluster randomised controlled trial. BMJ Open. 2022 Apr 11;12(4):e057311. doi: 10.1136/bmjopen-2021-057311.
Other Identifiers
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55803
Identifier Type: -
Identifier Source: org_study_id
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