Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (HomeBase)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Behavioral: Home-based pulmonary rehabilitation Behavioral: Hospital-based pulmonary rehabilitation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease |
- Change in 6-minute walk test [ Time Frame: Baseline, 8 weeks and 12 months ] [ Designated as safety issue: No ]Testing equivalence between groups
- Change in Chronic Respiratory Disease Questionnaire [ Time Frame: Baseline, 8 weeks and 12 months ] [ Designated as safety issue: No ]
- Change in Modified Medical Research Council Scale [ Time Frame: Baseline, 8 weeks and 12 months ] [ Designated as safety issue: No ]
- Cost-effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- SF-36 v2 [ Time Frame: Baseline, 8 weeks and 12 months ] [ Designated as safety issue: No ]Contributes to cost effectiveness analysis
- Program completion rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 144 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Home-based pulmonary rehabilitation
Home visit plus 8 weeks of once-weekly telephone calls
|
Behavioral: Home-based pulmonary rehabilitation
One home visit plus weekly telephone calls for 8 weeks
|
|
Active Comparator: Hospital-based pulmonary rehabilitation
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
|
Behavioral: Hospital-based pulmonary rehabilitation
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Anne E Holland, PhD | 0011 613 94796744 | a.holland@alfred.org.au |
| Contact: Angela Burge, MPhysio | 0011 613 9076 3852 | a.burge@alfred.org.au |
| Australia, Victoria | |
| Austin Health | Recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Contact: Christine F McDonald, PhD +61 3 94965739 christine.mcdonald@austin.org.au | |
| Contact: Catherine Hill, PhD +61 3 9496 5461 catherine.hill@austin.org.au | |
| Principal Investigator: Christine McDonald, PhD | |
| Sub-Investigator: Catherine J Hill, PhD | |
| Alfred Health | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Anne E Holland, PhD +61 3 94796744 a.holland@latrobe.edu.au | |
| Contact: Angela Burge, MPhysio +613 9067 3852 a.burge@alfred.org.au | |
| Principal Investigator: Anne E Holland, PhD | |
| Sub-Investigator: Annemarie Lee, PhD | |
| Sub-Investigator: Angela Burge, MPhysio | |
| Principal Investigator: | Anne E Holland, PhD | La Trobe University, Alfred Health, Institute for Breathing and Sleep |
| Principal Investigator: | Christine F McDonald, PhD | Austin Health, Institute for Breathing and Sleep |
| Principal Investigator: | Ajay Mahal, PhD | Monash University |
More Information
No publications provided
| Responsible Party: | Anne Holland, Associate Professor, La Trobe University |
| ClinicalTrials.gov Identifier: | NCT01423227 History of Changes |
| Other Study ID Numbers: | HomeBase |
| Study First Received: | August 11, 2011 |
| Last Updated: | July 24, 2012 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by La Trobe University:
|
COPD exercise rehabilitation |
dyspnea quality of life economic evaluation |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013