Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04217330

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

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
490 (estimated)
Sponsor
Monash University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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

TypeNameDescription
BEHAVIORALChoice of home-based or centre-based pulmonary rehabilitationParticipants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program.
BEHAVIORALCentre-based pulmonary rehabilitationParticipants will be offered a traditional centre-based pulmonary rehabilitation program

Timeline

Start date
2021-03-01
Primary completion
2026-02-01
Completion
2026-02-01
First posted
2020-01-03
Last updated
2025-07-08

Locations

11 sites across 1 country: Australia

Source: ClinicalTrials.gov record NCT04217330. Inclusion in this directory is not an endorsement.