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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

Resource links provided by NLM:


Further study details as provided by La Trobe University:

Primary Outcome Measures:
  • Change in 6-minute walk test [ Time Frame: Baseline, 8 weeks and 12 months ] [ Designated as safety issue: No ]
    Testing equivalence between groups


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423227

Contacts
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

Locations
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         
Sponsors and Collaborators
La Trobe University
The Alfred
Austin Health
Monash University
Investigators
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 by La Trobe University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014