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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04217330




Registration number
NCT04217330
Ethics application status
Date submitted
17/12/2019
Date registered
3/01/2020
Date last updated
3/01/2020

Titles & IDs
Public title
An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD
Scientific title
HomeBase2: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease
Secondary ID [1] 0 0
55803
Universal Trial Number (UTN)
Trial acronym
HomeBase2
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 - Choice of home-based or centre-based pulmonary rehabilitation
Behaviour - Centre-based pulmonary rehabilitation

Experimental: Intervention - Pulmonary rehabilitation programs assigned to the intervention group will offer eligible participants the choice of participating in an 8-week program of either home-based pulmonary rehabilitation or traditional centre-based pulmonary rehabilitation.

Active Comparator: Control - Pulmonary rehabilitation programs assigned to the control group will offer eligible participants the opportunity to participate in an 8-week centre-based pulmonary rehabilitation program, as per current practice.


Behaviour: Choice of home-based or centre-based pulmonary rehabilitation
Participants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program.

Behaviour: Centre-based pulmonary rehabilitation
Participants will be offered a traditional centre-based pulmonary rehabilitation program

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

Outcomes
Primary outcome [1] 0 0
All cause, non-elective hospitalisation - The number of participants hospitalised at least once will be compared between groups
Timepoint [1] 0 0
12 months after completing pulmonary rehabilitation
Secondary outcome [1] 0 0
Change in 6-minute walk distance - Distance walked in 6 minutes
Timepoint [1] 0 0
End of rehabilitation and 12 months later
Secondary outcome [2] 0 0
Change in chronic respiratory disease questionnaire total and domain scores - Disease-specific health-related quality of life measure; scores range 1-7, higher scores indicate better health-related quality of life
Timepoint [2] 0 0
End of rehabilitation and 12 months later
Secondary outcome [3] 0 0
EQ-5D-5L - Generic health-related quality of life measure to inform economic analysis; 5 dimensions each scored 1-5 with lower values indicating better health-related quality of life
Timepoint [3] 0 0
End of rehabilitation and 12 months later
Secondary outcome [4] 0 0
Change in dyspnoea-12 - Global measure of breathlessness; total scores range from 0 to 36, with higher scores corresponding to greater severity of dyspnoea
Timepoint [4] 0 0
End of rehabilitation and 12 months later
Secondary outcome [5] 0 0
Change in objectively measured physical activity - Objective measure of physical activity using the actigraph
Timepoint [5] 0 0
End of rehabilitation and 12 months later
Secondary outcome [6] 0 0
Health care costs - Health care costs in Australian dollars will be calculated using health care utilisation data including hospitalisation, primary care visits and medication use
Timepoint [6] 0 0
12 months following pulmonary rehabilitation completion
Secondary outcome [7] 0 0
Program completion - The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).
Timepoint [7] 0 0
End of rehabilitation

Eligibility
Key inclusion criteria
Inclusion criteria for pulmonary rehabilitation programs:

• Outpatient pulmonary rehabilitation programs that admit at least 50 people with COPD each
year.

Inclusion criteria for participants:

- Diagnosis of COPD confirmed on spirometry

- Able to read, write and speak English

- Able to provide informed consent.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Attended pulmonary rehabilitation within 1 year

- Comorbidities which preclude exercise training.

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 receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
NSW,NT,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Mount Druitt Hospital - Sydney
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Sydney
Recruitment hospital [5] 0 0
Top End Health Service - Darwin
Recruitment hospital [6] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [7] 0 0
Central Adelaide Local Health Network - Adelaide
Recruitment hospital [8] 0 0
Southern Adelaide Local Health Network - Adelaide
Recruitment hospital [9] 0 0
Peninsula Health - Melbourne
Recruitment hospital [10] 0 0
St John of God Frankston Rehabilitation - Melbourne
Recruitment hospital [11] 0 0
Western Health - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Darwin
Recruitment postcode(s) [4] 0 0
4032 - Brisbane
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment postcode(s) [6] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Institute for Breathing and Sleep, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
La Trobe University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Thoracic Society of Australia and New Zealand
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Lung Foundation Australia
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
People with chronic obstructive pulmonary disease (COPD) experience distressing
breathlessness and high health care utilisation. There is compelling evidence that pulmonary
rehabilitation improves symptoms and reduces hospitalisation, but is delivered to <10% of
patients who would benefit. The investigators developed a low cost model of pulmonary
rehabilitation that can be delivered entirely at home. The HomeBase model had equivalent
outcomes to centre-based pulmonary rehabilitation in a phase II efficacy trial, with higher
completion rates. The investigators hypothesise that a patient centred model offering a
choice between home or centre-based pulmonary rehabilitation may increase program completion
rates, with improved outcomes for patients and the health system.

This is a cluster randomised implementation trial investigating whether offering a choice of
home or centre-based pulmonary rehabilitation can reduce hospitalisation, improve pulmonary
rehabilitation completion and enhance patient outcomes in people with COPD. 14 pulmonary
rehabilitation programs located across Australia will each recruit 35 people with COPD.
Intervention centres: People with COPD will be offered the choice of centre-based pulmonary
rehabilitation or the HomeBase model. Comparison centres: Only the existing centre-based
model will be offered. The primary outcome is all cause, non-elective hospitalisation at 12
months. Other outcomes are symptoms, exercise capacity and quality of life at 8 weeks and 12
months; and health care costs at 12 months for full economic evaluation.
Trial website
https://clinicaltrials.gov/show/NCT04217330
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne Holland
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anne Holland
Address 0 0
Country 0 0
Phone 0 0
+61 3 99030214
Fax 0 0
Email 0 0
a.holland@alfred.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04217330