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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Choice of home-based or centre-based pulmonary rehabilitation
* Behavioral: Centre-based pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized trial
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary rehabilitation, Implementation, COPD