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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01423227
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
The Alfred
Austin Health
Monash University
Information provided by (Responsible Party):
Anne Holland, 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


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Behavioral: Home-based pulmonary rehabilitation Behavioral: Hospital-based pulmonary rehabilitation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Study Start Date : October 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in 6-minute walk test [ Time Frame: Baseline, 8 weeks and 12 months ]
    Testing equivalence between groups


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423227


Locations
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Australia, Victoria
Austin Health
Heidelberg, Victoria, Australia, 3084
Alfred Health
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
La Trobe University
The Alfred
Austin Health
Monash University
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anne Holland, Associate Professor, La Trobe University
ClinicalTrials.gov Identifier: NCT01423227    
Other Study ID Numbers: HomeBase
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Anne Holland, La Trobe University:
COPD
exercise
rehabilitation
dyspnea
quality of life
economic evaluation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases