An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD (HomeBase2)

October 17, 2023 updated by: Anne E Holland PhD, FThorSoc, Monash University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

490

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
          • Renae McNamara
      • Sydney, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Lissa Spencer
      • Sydney, New South Wales, Australia
        • Not yet recruiting
        • Westmead Hospital
        • Contact:
          • Mary Roberts
      • Sydney, New South Wales, Australia
        • Not yet recruiting
        • Mount Druitt Hospital
        • Contact:
          • Mary Roberts
    • Northern Territory
      • Darwin, Northern Territory, Australia
        • Not yet recruiting
        • Top End Health Service
        • Contact:
          • Coralie Brannelly
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Not yet recruiting
        • Prince Charles Hospital
        • Contact:
          • James Walsh
    • South Australia
      • Adelaide, South Australia, Australia
        • Not yet recruiting
        • Central Adelaide Local Health Network
        • Contact:
          • Michelle Peskett
      • Adelaide, South Australia, Australia
        • Recruiting
        • Southern Adelaide Local Health Network
        • Contact:
          • Laura Cooper
    • Victoria
      • Melbourne, Victoria, Australia
        • Not yet recruiting
        • Peninsula Health
        • Contact:
          • Esther Yiu
      • Melbourne, Victoria, Australia
        • Not yet recruiting
        • St John of God Frankston Rehabilitation
        • Contact:
          • Ashley Lewis
      • Melbourne, Victoria, Australia
        • Not yet recruiting
        • Western Health
        • Contact:
          • Kathryn Barker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
Participants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program.
Active Comparator: Control
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
Participants will be offered a traditional centre-based pulmonary rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months after completing pulmonary rehabilitation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6-minute walk distance
Time Frame: End of rehabilitation and 12 months later
Distance walked in 6 minutes
End of rehabilitation and 12 months later
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
End of rehabilitation and 12 months later
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
End of rehabilitation and 12 months later
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
End of rehabilitation and 12 months later
Change in objectively measured physical activity
Time Frame: End of rehabilitation and 12 months later
Objective measure of physical activity using the actigraph
End of rehabilitation and 12 months later
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
12 months following pulmonary rehabilitation completion
Program completion
Time Frame: End of rehabilitation
The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).
End of rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University

Collaborators

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

Investigators

  • Principal Investigator: Anne Holland, Monash University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

January 1, 2020

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will make individual participant data available to other researchers for related projects with appropriate ethical oversight. The data provided would be in re-identifiable form with no identifying information provided. 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.

IPD Sharing Time Frame

After publication of the main trial results, for 7 years.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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