Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Hospital-based pulmonary rehabilitation; Behavioral: Home-based pulmonary rehabilitation

• Registration Number: NCT01423227
• Lead Sponsor: La Trobe University

Brief Summary

Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program.

We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months.

If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-24
• Study First Posted: 2011-08-25
• Study Start: 2011-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• current or former smokers of at least 10 packet years
• aged 40 years or over
• diagnosis of COPD confirmed on spirometry.

Exclusion Criteria

• previous diagnosis of asthma
• have attended a pulmonary rehabilitation program in the last two years
• exacerbation of COPD within the last four weeks
• have comorbidities which prevent participation in an exercise training program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospital-based pulmonary rehabilitation	Hospital-based pulmonary rehabilitation	Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
Home-based pulmonary rehabilitation	Home-based pulmonary rehabilitation	Home visit plus 8 weeks of once-weekly telephone calls

Primary Outcome Measures

Name	Time	Method
Change in 6-minute walk test	Baseline, 8 weeks and 12 months	Testing equivalence between groups

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	12 months
Program completion rate	8 weeks
SF-36 v2	Baseline, 8 weeks and 12 months	Contributes to cost effectiveness analysis
Change in Chronic Respiratory Disease Questionnaire	Baseline, 8 weeks and 12 months
Change in Modified Medical Research Council Scale	Baseline, 8 weeks and 12 months

Trial Locations

Locations (2)

Austin Health; 🇦🇺 Heidelberg, Victoria, Australia

Alfred Health; 🇦🇺 Melbourne, Victoria, Australia