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

Chronic Obstructive Pulmonary Disease Clinical Trial

— HomeBase2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04217330
• Other study ID #: 55803
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 2025

Study information

• Verified date: October 2023
• Source: Monash University
• Contact: Anne Holland
• Phone: +61 3 99030214
• Email: a.holland[@]alfred.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Australia	Central Adelaide Local Health Network	Adelaide	South Australia
Australia	Southern Adelaide Local Health Network	Adelaide	South Australia
Australia	Prince Charles Hospital	Brisbane	Queensland
Australia	Top End Health Service	Darwin	Northern Territory
Australia	Peninsula Health	Melbourne	Victoria
Australia	St John of God Frankston Rehabilitation	Melbourne	Victoria
Australia	Western Health	Melbourne	Victoria
Australia	Mount Druitt Hospital	Sydney	New South Wales
Australia	Prince of Wales Hospital	Sydney	New South Wales
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Sydney	New South Wales

Sponsors (6)

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

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause, non-elective hospitalisation	The number of participants hospitalised at least once will be compared between groups	12 months after completing pulmonary rehabilitation
Secondary	Change in 6-minute walk distance	Distance walked in 6 minutes	End of rehabilitation and 12 months later
Secondary	Change in chronic respiratory disease questionnaire total and domain scores	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
Secondary	EQ-5D-5L	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
Secondary	Change in dyspnoea-12	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
Secondary	Change in objectively measured physical activity	Objective measure of physical activity using the actigraph	End of rehabilitation and 12 months later
Secondary	Health care costs	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
Secondary	Program completion	The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).	End of rehabilitation