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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

Tracking Information
First Submitted Date  ICMJE August 11, 2011
First Posted Date  ICMJE August 25, 2011
Last Update Posted Date August 14, 2019
Study Start Date  ICMJE October 2011
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2011)
Change in 6-minute walk test [ Time Frame: Baseline, 8 weeks and 12 months ]
Testing equivalence between groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2011)
  • Change in Chronic Respiratory Disease Questionnaire [ Time Frame: Baseline, 8 weeks and 12 months ]
  • Change in Modified Medical Research Council Scale [ Time Frame: Baseline, 8 weeks and 12 months ]
  • Cost-effectiveness [ Time Frame: 12 months ]
  • SF-36 v2 [ Time Frame: Baseline, 8 weeks and 12 months ]
    Contributes to cost effectiveness analysis
  • Program completion rate [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Official Title  ICMJE Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Behavioral: Home-based pulmonary rehabilitation
    One home visit plus weekly telephone calls for 8 weeks
  • Behavioral: Hospital-based pulmonary rehabilitation
    Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
Study Arms  ICMJE
  • Experimental: Home-based pulmonary rehabilitation
    Home visit plus 8 weeks of once-weekly telephone calls
    Intervention: Behavioral: Home-based pulmonary rehabilitation
  • Active Comparator: Hospital-based pulmonary rehabilitation
    Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
    Intervention: Behavioral: Hospital-based pulmonary rehabilitation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 24, 2011)
144
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01423227
Other Study ID Numbers  ICMJE HomeBase
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne Holland, La Trobe University
Study Sponsor  ICMJE La Trobe University
Collaborators  ICMJE
  • The Alfred
  • Austin Health
  • Monash University
Investigators  ICMJE
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
PRS Account La Trobe University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP