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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Home-based pulmonary rehabilitation
Hospital-based pulmonary rehabilitation
Sponsored by
La Trobe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, exercise, rehabilitation, dyspnea, quality of life, economic evaluation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Austin Health
  • Alfred Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home-based pulmonary rehabilitation

Hospital-based pulmonary rehabilitation

Arm Description

Home visit plus 8 weeks of once-weekly telephone calls

Standard twice-weekly 8-week outpatient pulmonary rehabilitation program

Outcomes

Primary Outcome Measures

Change in 6-minute walk test
Testing equivalence between groups

Secondary Outcome Measures

Change in Chronic Respiratory Disease Questionnaire
Change in Modified Medical Research Council Scale
Cost-effectiveness
SF-36 v2
Contributes to cost effectiveness analysis
Program completion rate

Full Information

First Posted
August 11, 2011
Last Updated
August 12, 2019
Sponsor
La Trobe University
Collaborators
The Alfred, Austin Health, Monash University
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1. Study Identification

Unique Protocol Identification Number
NCT01423227
Brief Title
Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Acronym
HomeBase
Official Title
Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
La Trobe University
Collaborators
The Alfred, Austin Health, Monash University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, exercise, rehabilitation, dyspnea, quality of life, economic evaluation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based pulmonary rehabilitation
Arm Type
Experimental
Arm Description
Home visit plus 8 weeks of once-weekly telephone calls
Arm Title
Hospital-based pulmonary rehabilitation
Arm Type
Active Comparator
Arm Description
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
Intervention Type
Behavioral
Intervention Name(s)
Home-based pulmonary rehabilitation
Intervention Description
One home visit plus weekly telephone calls for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Hospital-based pulmonary rehabilitation
Intervention Description
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
Primary Outcome Measure Information:
Title
Change in 6-minute walk test
Description
Testing equivalence between groups
Time Frame
Baseline, 8 weeks and 12 months
Secondary Outcome Measure Information:
Title
Change in Chronic Respiratory Disease Questionnaire
Time Frame
Baseline, 8 weeks and 12 months
Title
Change in Modified Medical Research Council Scale
Time Frame
Baseline, 8 weeks and 12 months
Title
Cost-effectiveness
Time Frame
12 months
Title
SF-36 v2
Description
Contributes to cost effectiveness analysis
Time Frame
Baseline, 8 weeks and 12 months
Title
Program completion rate
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne E Holland, PhD
Organizational Affiliation
La Trobe University, Alfred Health, Institute for Breathing and Sleep
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine F McDonald, PhD
Organizational Affiliation
Austin Health, Institute for Breathing and Sleep
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ajay Mahal, PhD
Organizational Affiliation
Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
33511633
Citation
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
Results Reference
derived
PubMed Identifier
33228654
Citation
Grimwood CL, Holland AE, McDonald CF, Mahal A, Hill CJ, Lee AL, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, Burge AT. Comparison of self-report and administrative data sources to capture health care resource use in people with chronic obstructive pulmonary disease following pulmonary rehabilitation. BMC Health Serv Res. 2020 Nov 23;20(1):1061. doi: 10.1186/s12913-020-05920-0.
Results Reference
derived
PubMed Identifier
31418515
Citation
Burge AT, Holland AE, McDonald CF, Abramson MJ, Hill CJ, Lee AL, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, Mahal A. Home-based pulmonary rehabilitation for COPD using minimal resources: An economic analysis. Respirology. 2020 Feb;25(2):183-190. doi: 10.1111/resp.13667. Epub 2019 Aug 16.
Results Reference
derived
PubMed Identifier
31239657
Citation
Hoaas H, Zanaboni P, Hjalmarsen A, Morseth B, Dinesen B, Burge AT, Cox NS, Holland AE. Seasonal variations in objectively assessed physical activity among people with COPD in two Nordic countries and Australia: a cross-sectional study. Int J Chron Obstruct Pulmon Dis. 2019 Jun 5;14:1219-1228. doi: 10.2147/COPD.S194622. eCollection 2019.
Results Reference
derived
PubMed Identifier
30688793
Citation
Lahham A, McDonald CF, Mahal A, Lee AL, Hill CJ, Burge AT, Cox NS, Moore R, Nicolson C, O'Halloran P, Gillies R, Holland AE. Participation in Physical Activity During Center and Home-Based Pulmonary Rehabilitation for People With COPD: A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2019 Mar;39(2):E1-E4. doi: 10.1097/HCR.0000000000000373.
Results Reference
derived
PubMed Identifier
30316548
Citation
Liacos A, McDonald CF, Mahal A, Hill CJ, Lee AL, Burge AT, Moore R, Nicolson C, O'Halloran P, Cox NS, Lahham A, Gillies R, Holland AE. The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool predicts reduction in sedentary time following pulmonary rehabilitation in people with chronic obstructive pulmonary disease (COPD). Physiotherapy. 2019 Mar;105(1):90-97. doi: 10.1016/j.physio.2018.07.009. Epub 2018 Aug 3.
Results Reference
derived
PubMed Identifier
27672116
Citation
Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, McDonald CF. Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. Thorax. 2017 Jan;72(1):57-65. doi: 10.1136/thoraxjnl-2016-208514. Epub 2016 Sep 26.
Results Reference
derived
PubMed Identifier
24011178
Citation
Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Moore R, Nicolson C, O'Halloran P, Cox NS, Lahham A, Ndongo R, Bell E, McDonald CF. Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial. BMC Pulm Med. 2013 Sep 8;13:57. doi: 10.1186/1471-2466-13-57.
Results Reference
derived

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

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