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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01423227




Registration number
NCT01423227
Ethics application status
Date submitted
11/08/2011
Date registered
25/08/2011
Date last updated
14/08/2019

Titles & IDs
Public title
Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Scientific title
Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Secondary ID [1] 0 0
HomeBase
Universal Trial Number (UTN)
Trial acronym
HomeBase
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Home-based pulmonary rehabilitation
BEHAVIORAL - Hospital-based pulmonary rehabilitation

Experimental: Home-based pulmonary rehabilitation - Home visit plus 8 weeks of once-weekly telephone calls

Active comparator: Hospital-based pulmonary rehabilitation - Standard twice-weekly 8-week outpatient pulmonary rehabilitation program


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
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in 6-minute walk test
Timepoint [1] 0 0
Baseline, 8 weeks and 12 months
Secondary outcome [1] 0 0
Change in Chronic Respiratory Disease Questionnaire
Timepoint [1] 0 0
Baseline, 8 weeks and 12 months
Secondary outcome [2] 0 0
Change in Modified Medical Research Council Scale
Timepoint [2] 0 0
Baseline, 8 weeks and 12 months
Secondary outcome [3] 0 0
Cost-effectiveness
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
SF-36 v2
Timepoint [4] 0 0
Baseline, 8 weeks and 12 months
Secondary outcome [5] 0 0
Program completion rate
Timepoint [5] 0 0
8 weeks

Eligibility
Key inclusion criteria
* current or former smokers of at least 10 packet years
* aged 40 years or over
* diagnosis of COPD confirmed on spirometry.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
La Trobe University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Austin Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT01423227
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Anne E Holland, PhD
Address 0 0
La Trobe University, Alfred Health, Institute for Breathing and Sleep
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01423227