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NCT Number: NCT04217330

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Druitt Hospital, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

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

Treatment and study plan

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.

Centre-based pulmonary rehabilitation

Behavioral

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

Primary outcomes

  1. All cause, non-elective hospitalisation

    Time frame: 12 months after completing pulmonary rehabilitation

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

Secondary outcomes

  1. Change in 6-minute walk distance

    Time frame: End of rehabilitation and 12 months later

    Distance walked in 6 minutes

  2. Change in chronic respiratory disease questionnaire total and domain scores

    Time frame: End of rehabilitation and 12 months later

    Disease-specific health-related quality of life measure; scores range 1-7, higher scores indicate better health-related quality of life

  3. EQ-5D-5L

    Time frame: End of rehabilitation and 12 months later

    Generic health-related quality of life measure to inform economic analysis; 5 dimensions each scored 1-5 with lower values indicating better health-related quality of life

  4. Change in dyspnoea-12

    Time frame: End of rehabilitation and 12 months later

    Global measure of breathlessness; total scores range from 0 to 36, with higher scores corresponding to greater severity of dyspnoea

  5. Change in objectively measured physical activity

    Time frame: End of rehabilitation and 12 months later

    Objective measure of physical activity using the actigraph

  6. Health care costs

    Time frame: 12 months following pulmonary rehabilitation completion

    Health care costs in Australian dollars will be calculated using health care utilisation data including hospitalisation, primary care visits and medication use

  7. Program completion

    Time frame: End of rehabilitation

    The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

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

Registry information

Official study title

HomeBase2: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease

Acronym: HomeBase2

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2020
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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