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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04217330
Registration number
NCT04217330
Ethics application status
Date submitted
17/12/2019
Date registered
3/01/2020
Titles & IDs
Public title
An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD
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Scientific title
HomeBase2: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease
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Secondary ID [1]
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55803
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Universal Trial Number (UTN)
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Trial acronym
HomeBase2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - Choice of home-based or centre-based pulmonary rehabilitation
BEHAVIORAL - 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.
BEHAVIORAL: 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.
BEHAVIORAL: Centre-based pulmonary rehabilitation
Participants will be offered a traditional centre-based pulmonary rehabilitation program
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All cause, non-elective hospitalisation
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Assessment method [1]
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The number of participants hospitalised at least once will be compared between groups
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Timepoint [1]
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12 months after completing pulmonary rehabilitation
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Secondary outcome [1]
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Change in 6-minute walk distance
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Assessment method [1]
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Distance walked in 6 minutes
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Timepoint [1]
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End of rehabilitation and 12 months later
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Secondary outcome [2]
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Change in chronic respiratory disease questionnaire total and domain scores
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Assessment method [2]
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Disease-specific health-related quality of life measure; scores range 1-7, higher scores indicate better health-related quality of life
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Timepoint [2]
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End of rehabilitation and 12 months later
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Secondary outcome [3]
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EQ-5D-5L
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Assessment method [3]
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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
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Timepoint [3]
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End of rehabilitation and 12 months later
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Secondary outcome [4]
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Change in dyspnoea-12
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Assessment method [4]
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Global measure of breathlessness; total scores range from 0 to 36, with higher scores corresponding to greater severity of dyspnoea
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Timepoint [4]
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End of rehabilitation and 12 months later
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Secondary outcome [5]
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Change in objectively measured physical activity
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Assessment method [5]
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Objective measure of physical activity using the actigraph
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Timepoint [5]
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End of rehabilitation and 12 months later
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Secondary outcome [6]
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Health care costs
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Assessment method [6]
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Health care costs in Australian dollars will be calculated using health care utilisation data including hospitalisation, primary care visits and medication use
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Timepoint [6]
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12 months following pulmonary rehabilitation completion
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Secondary outcome [7]
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Program completion
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Assessment method [7]
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The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).
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Timepoint [7]
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End of rehabilitation
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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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Attended pulmonary rehabilitation within 1 year
* Comorbidities which preclude exercise training.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2025
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Actual
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Sample size
Target
490
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [2]
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Mount Druitt Hospital - Sydney
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Recruitment hospital [3]
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Prince of Wales Hospital - Sydney
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Recruitment hospital [4]
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Westmead Hospital - Sydney
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Recruitment hospital [5]
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Top End Health Service - Darwin
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Recruitment hospital [6]
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Prince Charles Hospital - Brisbane
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Recruitment hospital [7]
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Central Adelaide Local Health Network - Adelaide
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Recruitment hospital [8]
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Southern Adelaide Local Health Network - Adelaide
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Recruitment hospital [9]
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Peninsula Health - Melbourne
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Recruitment hospital [10]
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St John of God Frankston Rehabilitation - Melbourne
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Recruitment hospital [11]
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Western Health - Melbourne
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Recruitment postcode(s) [1]
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2050 - Sydney
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Recruitment postcode(s) [2]
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- Sydney
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Recruitment postcode(s) [3]
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- Darwin
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Recruitment postcode(s) [4]
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4032 - Brisbane
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Recruitment postcode(s) [5]
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- Adelaide
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Recruitment postcode(s) [6]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Institute for Breathing and Sleep, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Melbourne
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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La Trobe University
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Thoracic Society of Australia and New Zealand
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Lung Foundation Australia
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04217330
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Trial related presentations / publications
Holland AE, Jones AW, Mahal A, Lannin NA, Cox N, Hepworth G, O'Halloran P, McDonald CF. Implementing a choice of pulmonary rehabilitation models in chronic obstructive pulmonary disease (HomeBase2 trial): protocol for a cluster randomised controlled trial. BMJ Open. 2022 Apr 11;12(4):e057311. doi: 10.1136/bmjopen-2021-057311.
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Public notes
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Contacts
Principal investigator
Name
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Anne Holland
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Anne Holland
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Address
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Country
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Phone
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+61 3 99030214
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The investigators will make individual participant data available to other researchers for related projects with appropriate ethical oversight. The data provided would be in re-identifiable form with no identifying information provided. Access will only be granted to researchers who agree to preserve the confidentiality of the information. Access will require approval from the research team as well as approval from a Human Research Ethics Committee.
Supporting document/s available: Study protocol, Informed consent form (ICF)
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When will data be available (start and end dates)?
After publication of the main trial results, for 7 years.
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Available to whom?
Access will only be granted to researchers who agree to preserve the confidentiality of the information. Access will require approval from the research team as well as approval from a Human Research Ethics Committee
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Available for what types of analyses?
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How or where can data be obtained?
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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/NCT04217330