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

NCT ID: NCT01423227

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home-based pulmonary rehabilitation

Home visit plus 8 weeks of once-weekly telephone calls

Group Type EXPERIMENTAL

Home-based pulmonary rehabilitation

Intervention Type BEHAVIORAL

One home visit plus weekly telephone calls for 8 weeks

Hospital-based pulmonary rehabilitation

Standard twice-weekly 8-week outpatient pulmonary rehabilitation program

Group Type ACTIVE_COMPARATOR

Hospital-based pulmonary rehabilitation

Intervention Type BEHAVIORAL

Standard twice-weekly 8-week outpatient pulmonary rehabilitation program

Interventions

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Home-based pulmonary rehabilitation

One home visit plus weekly telephone calls for 8 weeks

Intervention Type BEHAVIORAL

Hospital-based pulmonary rehabilitation

Standard twice-weekly 8-week outpatient pulmonary rehabilitation program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Alfred

OTHER

Sponsor Role collaborator

Austin Health

OTHER_GOV

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role collaborator

La Trobe University

OTHER

Sponsor Role lead

Responsible Party

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Anne Holland

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne E Holland, PhD

Role: PRINCIPAL_INVESTIGATOR

La Trobe University, Alfred Health, Institute for Breathing and Sleep

Christine F McDonald, PhD

Role: PRINCIPAL_INVESTIGATOR

Austin Health, Institute for Breathing and Sleep

Ajay Mahal, PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University

Locations

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Austin Health

Heidelberg, Victoria, Australia

Site Status

Alfred Health

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 33511633 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33228654 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31418515 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31239657 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30688793 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30316548 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27672116 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24011178 (View on PubMed)

Other Identifiers

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HomeBase

Identifier Type: -

Identifier Source: org_study_id

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