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

Study acronym: HomeBase2
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed Final enrollment: 439 participants (planned 490) · Primary completion date changed from estimate of Feb 2026 to Apr 10, 2026 · Publications: details revised at 2 of 2 entries · 1 more Show 4 more changesShow less
    • Final enrollment: 439 participants (planned 490)
    • Primary completion date changed from estimate of Feb 2026 to Apr 10, 2026
    • Publications: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 5 words
  2. Notable Primary completion date: Dec 2024 to Feb 2026 Trial status: Recruiting to Active, Not Recruiting · Completion date: Dec 2025 to Feb 2026 · Site details revised at 11 of 11 sitesv6 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Dec 2025 to Feb 2026
    • Site details revised at 11 of 11 sites
  3. Minor Primary completion date: Aug 2024 to Dec 2024 Completion date: Aug 2025 to Dec 2025v5 Show 1 more changeShow less
    • Completion date: Aug 2025 to Dec 2025
  4. Notable Primary completion date: Sep 2023 to Aug 2024 Completion date: Dec 2023 to Aug 2025v4 Show 1 more changeShow less
    • Completion date: Dec 2023 to Aug 2025
  5. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 2022 to Sep 2023 · Completion date: Jun 2023 to Dec 2023 · Start date changed from estimate of Feb 2021 to Mar 1, 2021 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Dec 2022 to Sep 2023
    • Completion date: Jun 2023 to Dec 2023
    • Start date changed from estimate of Feb 2021 to Mar 1, 2021
    • Site details revised at 11 of 11 sites
  6. Notable Start date: Feb 2020 to Feb 2021v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT04217330
Lead Sponsor Monash University
Collaborators: Institute for Breathing and Sleep, Australia, University of Melbourne, La Trobe University, Thoracic Society of Australia and New Zealand, Lung Foundation Australia
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 439 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov