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

Last updated: November 19, 2024
Sponsor: Monash University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Choice of home-based or centre-based pulmonary rehabilitation

Centre-based pulmonary rehabilitation

Clinical Study ID

NCT04217330
55803
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion criteria for pulmonary rehabilitation programs:

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

Inclusion criteria for participants:

  • Diagnosis of COPD confirmed on spirometry

  • Able to read, write and speak English

  • Able to provide informed consent.

Exclusion

Exclusion Criteria:

  • Attended pulmonary rehabilitation within 1 year

  • Comorbidities which preclude exercise training.

Study Design

Total Participants: 490
Treatment Group(s): 2
Primary Treatment: Choice of home-based or centre-based pulmonary rehabilitation
Phase:
Study Start date:
March 01, 2021
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Mount Druitt Hospital

    Sydney, New South Wales
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • Royal Prince Alfred Hospital

    Sydney, New South Wales 2050
    Australia

    Active - Recruiting

  • Westmead Hospital

    Sydney, New South Wales
    Australia

    Site Not Available

  • Top End Health Service

    Darwin, Northern Territory
    Australia

    Site Not Available

  • Prince Charles Hospital

    Brisbane, Queensland 4032
    Australia

    Site Not Available

  • Central Adelaide Local Health Network

    Adelaide, South Australia
    Australia

    Site Not Available

  • Southern Adelaide Local Health Network

    Adelaide, South Australia
    Australia

    Active - Recruiting

  • Peninsula Health

    Melbourne, Victoria
    Australia

    Site Not Available

  • St John of God Frankston Rehabilitation

    Melbourne, Victoria
    Australia

    Site Not Available

  • Western Health

    Melbourne, Victoria
    Australia

    Site Not Available

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