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

NCT04217330 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2025-07-08

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Centre-based pulmonary rehabilitation

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

Sponsors & Collaborators

  • Institute for Breathing and Sleep, Australia

    collaborator OTHER
  • University of Melbourne

    collaborator OTHER
  • La Trobe University

    collaborator OTHER
  • Thoracic Society of Australia and New Zealand

    collaborator UNKNOWN
  • Lung Foundation Australia

    collaborator UNKNOWN
  • Monash University

    lead OTHER

Principal Investigators

  • Anne Holland · Monash University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Australia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04217330 on ClinicalTrials.gov