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

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ClinicalTrials.gov Identifier: NCT01423227

Recruitment Status : Completed

First Posted : August 25, 2011

Last Update Posted : August 14, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

The Alfred

Austin Health

Monash University

Information provided by (Responsible Party):

Anne Holland, La Trobe University

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

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

Study Design

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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

MedlinePlus related topics: COPD Lung Diseases Rehabilitation

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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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

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

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.

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.

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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	Chronic Disease Disease Attributes Pathologic Processes

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