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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01423227