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Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT01423227
Ethics application status
Date submitted
11/08/2011
Date registered
24/08/2011
Date last updated
24/07/2012

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
Behaviour - Home-based pulmonary rehabilitation
Behaviour - 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


Behaviour: Home-based pulmonary rehabilitation
One home visit plus weekly telephone calls for 8 weeks

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

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

Outcomes
Primary outcome [1] 0 0
Change in 6-minute walk test - Testing equivalence between groups
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 - Contributes to cost effectiveness analysis
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
Gender
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
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Other
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/show/NCT01423227
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
Anne E Holland, PhD
Address 0 0
Country 0 0
Phone 0 0
0011 613 94796744
Fax 0 0
Email 0 0
a.holland@alfred.org.au
Contact person for scientific queries