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

Chronic Obstructive Pulmonary Disease Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423227
• Other study ID #: HomeBase
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Est. completion date: May 2015

Study information

• Verified date: August 2019
• Source: La Trobe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Home-based pulmonary rehabilitation
One home visit plus weekly telephone calls for 8 weeks
• Hospital-based pulmonary rehabilitation
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program

Locations

Country	Name	City	State
Australia	Austin Health	Heidelberg	Victoria
Australia	Alfred Health	Melbourne	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
La Trobe University	Austin Health, Monash University, The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6-minute walk test	Testing equivalence between groups	Baseline, 8 weeks and 12 months
Secondary	Change in Chronic Respiratory Disease Questionnaire		Baseline, 8 weeks and 12 months
Secondary	Change in Modified Medical Research Council Scale		Baseline, 8 weeks and 12 months
Secondary	Cost-effectiveness		12 months
Secondary	SF-36 v2	Contributes to cost effectiveness analysis	Baseline, 8 weeks and 12 months
Secondary	Program completion rate		8 weeks