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

NCT ID: NCT04217330

Last Updated: 2025-07-08

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2026-02-28

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants will be informed that the trial is assessing the impact of pulmonary rehabilitation models on patient and health system outcomes, but not the specific nature of the models of interest, or the intervention group to which their site has been allocated.

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.

Group Type EXPERIMENTAL

Choice of home-based or centre-based pulmonary rehabilitation

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Centre-based pulmonary rehabilitation

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Centre-based pulmonary rehabilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

• Outpatient pulmonary rehabilitation programs that admit at least 50 people with COPD each year.


* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute for Breathing and Sleep, Australia

OTHER

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role collaborator

La Trobe University

OTHER

Sponsor Role collaborator

Thoracic Society of Australia and New Zealand

UNKNOWN

Sponsor Role collaborator

Lung Foundation Australia

UNKNOWN

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role lead

Responsible Party

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Anne E Holland PhD, FThorSoc

Professor of Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Mount Druitt Hospital

Sydney, New South Wales, Australia

Site Status

Prince of Wales Hospital

Sydney, New South Wales, Australia

Site Status

Westmead Hospital

Sydney, New South Wales, Australia

Site Status

Top End Health Service

Darwin, Northern Territory, Australia

Site Status

Prince Charles Hospital

Brisbane, Queensland, Australia

Site Status

Central Adelaide Local Health Network

Adelaide, South Australia, Australia

Site Status

Southern Adelaide Local Health Network

Adelaide, South Australia, Australia

Site Status

Peninsula Health

Melbourne, Victoria, Australia

Site Status

St John of God Frankston Rehabilitation

Melbourne, Victoria, Australia

Site Status

Western Health

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

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.

Reference Type DERIVED
PMID: 36890526 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35410931 (View on PubMed)

Other Identifiers

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55803

Identifier Type: -

Identifier Source: org_study_id

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