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OpenTrials
Completed

NCT Number: NCT01423227

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

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Austin Health, Heidelberg, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based pulmonary rehabilitation

Behavioral

One home visit plus weekly telephone calls for 8 weeks

Hospital-based pulmonary rehabilitation

Behavioral

Standard twice-weekly 8-week outpatient pulmonary rehabilitation program

Primary outcomes

  1. Change in 6-minute walk test

    Time frame: Baseline, 8 weeks and 12 months

    Testing equivalence between groups

Secondary outcomes

  1. Change in Chronic Respiratory Disease Questionnaire

    Time frame: Baseline, 8 weeks and 12 months

  2. Change in Modified Medical Research Council Scale

    Time frame: Baseline, 8 weeks and 12 months

  3. Cost-effectiveness

    Time frame: 12 months

  4. SF-36 v2

    Time frame: Baseline, 8 weeks and 12 months

    Contributes to cost effectiveness analysis

  5. Program completion rate

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

La Trobe University

Other

Collaborators

  • Austin Health
  • Monash University
  • The Alfred

Registry information

Acronym: HomeBase

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2011
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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