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

This study is currently recruiting participants.
Verified July 2012 by La Trobe University
Sponsor:
Collaborators:
The Alfred
Austin Health
Monash University
Information provided by (Responsible Party):
Anne Holland, La Trobe University
ClinicalTrials.gov Identifier:
NCT01423227
First received: August 11, 2011
Last updated: July 24, 2012
Last verified: July 2012

August 11, 2011
July 24, 2012
October 2011
September 2014   (final data collection date for primary outcome measure)
Change in 6-minute walk test [ Time Frame: Baseline, 8 weeks and 12 months ] [ Designated as safety issue: No ]
Testing equivalence between groups
Same as current
Complete list of historical versions of study NCT01423227 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
October 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
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
 
NCT01423227
HomeBase
Yes
Anne Holland, La Trobe University
La Trobe University
  • The Alfred
  • Austin Health
  • Monash University
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
La Trobe University
July 2012

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