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

Monash University

Status: Active, not recruiting

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Choice of home-based or centre-based pulmonary rehabilitation; Behavioral: Centre-based pulmonary rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04217330

55803

Details and patient eligibility

About

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.

Enrollment: 490 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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490 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Choice of home-based or centre-based pulmonary rehabilitation

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Centre-based pulmonary rehabilitation