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

NCT04217330 | Active Not Recruiting DMC

• 1 other identifier: 55803
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 11

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary rehabilitation; Implementation; COPD

Outcome Measures

Primary Outcomes (1)

• All cause, non-elective hospitalisation

  The number of participants hospitalised at least once will be compared between groups

  12 months after completing pulmonary rehabilitation

Secondary Outcomes (7)

• Change in 6-minute walk distance

  End of rehabilitation and 12 months later

• Change in chronic respiratory disease questionnaire total and domain scores

  End of rehabilitation and 12 months later

• EQ-5D-5L

  End of rehabilitation and 12 months later

• Change in dyspnoea-12

  End of rehabilitation and 12 months later

• Change in objectively measured physical activity

  End of rehabilitation and 12 months later

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Choice of home-based or centre-based pulmonary rehabilitation

Control

ACTIVE COMPARATOR

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.

Behavioral: Centre-based pulmonary rehabilitation

Interventions

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

Participants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program.

Intervention

Centre-based pulmonary rehabilitation BEHAVIORAL

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

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Monash University: lead
• Institute for Breathing and Sleep, Australia: collaborator
• University of Melbourne: collaborator
• La Trobe University: collaborator
• Thoracic Society of Australia and New Zealand: collaborator
• Lung Foundation Australia: collaborator

Study Sites (11)

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Mount Druitt Hospital

Sydney, New South Wales, Australia

Location

Prince of Wales Hospital

Sydney, New South Wales, Australia

Location

Westmead Hospital

Sydney, New South Wales, Australia

Location

Top End Health Service

Darwin, Northern Territory, Australia

Location

Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

Central Adelaide Local Health Network

Adelaide, South Australia, Australia

Location

Southern Adelaide Local Health Network

Adelaide, South Australia, Australia

Location

Peninsula Health

Melbourne, Victoria, Australia

Location

St John of God Frankston Rehabilitation

Melbourne, Victoria, Australia

Location

Western Health

Melbourne, Victoria, Australia

Location

Related Publications (2)

• 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.

  PMID: 36890526 DERIVED

• 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.

  PMID: 35410931 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Holland

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiotherapy

Model Details: Cluster randomized trial

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 3, 2020
• Study Start: March 1, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication of the main trial results, for 7 years.
• Access Criteria: Access will only be granted to researchers who agree to preserve the confidentiality of the information. Access will require approval from the research team as well as approval from a Human Research Ethics Committee

Locations

AU (11)