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Trial registered on ANZCTR
Registration number
ACTRN12625001023448
Ethics application status
Approved
Date submitted
26/08/2025
Date registered
16/09/2025
Date last updated
16/09/2025
Date data sharing statement initially provided
16/09/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Piloting Implementation Strategies for Clinicians: Cardiovascular Rehabilitation for transient ischemic Attack and Mild Stroke
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Scientific title
From research to practice: piloting and evaluating clinical implementation strategies for Cardiovascular Rehabilitation for transient ischemic Attack and Mild Stroke
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Secondary ID [1]
315232
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None
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Universal Trial Number (UTN)
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Trial acronym
CRAMS 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
transient ischaemic attack
338687
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stroke
338688
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Condition category
Condition code
Cardiovascular
334970
334970
0
0
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Other cardiovascular diseases
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Stroke
334971
334971
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0
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Ischaemic
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Physical Medicine / Rehabilitation
334972
334972
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study will evaluate the potential effectiveness of implementation strategies targeted at improving uptake (clinician referral and delivery) of cardiac rehabilitation programs that include people with TIA or mild stroke, alongside people with Coronary Heart Disease (CHD), within one health service (Canberra Health Services) (North Canberra Hospital and The Canberra Hospital).
Phase II cardiac rehabilitation in Australia is multidisciplinary, time-limited (e.g. 6-weeks), conducted in groups, health service-based, and has educational and supervised exercise components. The aim of the individually tailored exercise sessions is to increase exercise capacity, and education sessions aim to increase the patient’s knowledge of their cardiovascular disease condition and increase risk factor self-management skills. In this study, people with TIA and mild stroke will be referred to, and included in the delivery of existing outpatient cardiac rehabilitation programs at two sites, The Canberra Hospital (TCH) and North Canberra Hospital (NCH). No modifications to existing cardiac rehabilitation exercise sessions are required for this study, however the inclusion of the above brain, ischemic stroke and TIA education as part of existing education sessions will be encouraged to promote integration
A multi-component implementation strategy intervention will be developed to increase the number of people with TIA or mild stroke who have been referred, commenced and completed cardiac rehabilitation. To achieve this, this study will be conducted in three phases over 12 months.
• Phase 1 (3-months): The ‘Experience based co-design toolkit for Australia’ five-step methodology will be used to develop and refine the implementation strategies: 5-10 stroke and cardiac rehabilitation clinicians, managers and TIA or mild stroke patients will be recruited to participate in 3-4 workshop to develop the implementation strategy intervention and provide feedback. Workshops will be facilitated by an experienced qualitative researcher and audio recorded and will occur approximately 2 weeks apart over a 2 month period. Workshop 1 will outline the project aims, providing background information before breaking into smaller groups for brainstorming and discussion to explore factors influencing the uptake (referral and delivery) of cardiac rehabilitation for people with TIA or mild stroke. The group will return together to summarize ideas and themes. Workshop 2, and 3 if needed, will begin with a summary of key themes and ideas from the previous workshop. Participants will be asked to identify feasible strategies to address the factors identified in workshop 1 that could increase the uptake (referral and delivery) of cardiac rehabilitation among people with TIA and mild stroke in existing services. Researchers will facilitate discussions and encourage stakeholders to problem-solve to reach agreement, utilizing information gathered from previous research. The Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) will be used to underpin the development and refinement of the implementation intervention and identify factors influencing potential implementation during the co-design process. A final workshop will be held once implementation strategies and resources have been developed by researchers, to provide feedback and finalize the overall implementation intervention.
• Phase 2 (the 3-months following phase 1): The multi-component implementation intervention will be delivered by the research team to stroke and cardiac rehabilitation clinicians, supporting cardiac rehabilitation uptake by people with TIA or mild stroke in their routine practice. The delivery of the implementation intervention will be largely contingent on the outcomes of phase 1 and hence further specifics cannot be provided at this time, however based on prior research this may include establishment of clear referral pathways and eligibility criteria, delivery of education to stroke or cardiac rehabilitation clinicians or increasing program awareness.
• Phase 3 (the 12-months following phase 2): The stroke and cardiac rehabilitation clinicians will be encouraged to utilise the implementation intervention over 12-months to support referral to and delivery of cardiac rehabilitation for people with TIA or mild stroke. We will then evaluate the effectiveness of the implementation strategy intervention at mid and end time-points of implementation strategy intervention rollout, over the 12 month period.
With informed consent, participants in this study will participate in co-design workshops (phase 1, first 3 months), interviews with research staff (phase 3, final 12 months), and an online survey (phase 3, final 12 months). Semi-covert observations of clinical settings to observe the use of implementation strategies will also be conducted by research staff in phase 3 (12 months). A resources and training log will be kept to log details on clinician training provided during delivery of the implementation strategy intervention (phase 2), and associated costs of the delivery. For the pre-post implementation comparison component of the study, hospital administrative data will be collected at the start and end of the 12-month implementation strategy intervention roll-out period, and will include number people with TIA or mild stroke referred, commenced and completed the cardiac rehabilitation program. No identifiable patient data will be collected.
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Intervention code [1]
331844
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Treatment: Other
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Comparator / control treatment
A control period will be used only for hospital administrative data. Hospital administrative data will include the number of people with TIA or mild stroke that were referred, commenced and completed cardiac rehabilitation, and will be collected for the 12 months prior to roll out of implementation strategies. There is no direct involvement with participants or patients here.
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Control group
Historical
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Outcomes
Primary outcome [1]
342603
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The primary implementation outcome is reach of cardiac rehabilitation for people with TIA or Mild stroke. That is, the number and proportion of the intended priority population (people with TIA or mild stroke) referred, commenced or completed the cardiac rehabilitation program.
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Assessment method [1]
342603
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This data will be collected from process-level hospital administrative data from cardiac rehabilitation programs.
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Timepoint [1]
342603
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At the start of implementation strategy intervention evaluation period (phase 3). At the end of implementation strategy intervention evaluation period (12 months following roll-out of the implementation strategies) (phase 3).
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Secondary outcome [1]
451503
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Acceptability of implementation strategies: The perception among clinicians’ that the implementation strategies are agreeable or satisfactory.
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Assessment method [1]
451503
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Quantitative survey data from the Acceptability of Intervention Measure (AIM) will be collected. Data collection will also include semi-structured interviews conducted with clinicians individually via phone or Microsoft Teams, each lasting approximately 30 minutes. These interviews will be audio-recorded and professionally transcribed. Field notes will also be maintained to capture contextual details and researcher reflections throughout the process.
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Timepoint [1]
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Mid-way through the implementation strategy intervention evaluation period (6-months following roll-out of the implementation strategies, phase 3). At the end of implementation strategy intervention evaluation period (12 months following roll-out of the implementation strategies, phase 3) (survey only conducted at the end and not mid-way).
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Secondary outcome [2]
451504
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Adoption of implementation strategies: The clinicians’ decision to employ the implementation strategies and the factors influencing this will be assessed.
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Assessment method [2]
451504
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Data collection will include qualitative, semi-covert observations of how implementation strategies are used during referral and program delivery, guided by a structured template. In addition, semi-structured interviews will be conducted with clinicians individually via phone or Microsoft Teams, each lasting approximately 30 minutes. These interviews will be audio-recorded and professionally transcribed. Field notes will also be maintained to capture contextual details and researcher reflections throughout the process.
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Timepoint [2]
451504
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Mid-way through the implementation strategy intervention evaluation period (6-months following roll-out of the implementation strategies, phase 3). At the end of implementation strategy intervention evaluation period (12 months following roll-out of the implementation strategies, phase 3)
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Secondary outcome [3]
451505
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Appropriateness of implementation strategies: The clinicians’ perception of how well the implementation strategies fit within their setting, existing workflow, role or skill set. This includes their perception on whether the strategies are suitable for supporting the inclusion of people with TIA and mild stroke in existing cardiac rehabilitation services.
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Assessment method [3]
451505
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Quantitative survey data from the Intervention Appropriateness Measure (IAM), qualitative notes in a resources and training log. Additionally, semi-covert observations of how implementation strategies are used during referral and program delivery, guided by a structured template. Semi-structured interviews will also be conducted with clinicians individually via phone or Microsoft Teams, each lasting approximately 30 minutes. These interviews will be audio-recorded and professionally transcribed. Field notes will also be maintained to capture contextual details and researcher reflections throughout the process. (phase 3).
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Timepoint [3]
451505
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Mid-way through the implementation strategy intervention evaluation period (6-months following roll-out of the implementation strategies, phase 3). At the end of implementation strategy intervention evaluation period (12 months following roll-out of the implementation strategies, phase 3) (survey only conducted at the end and not mid-way).
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Secondary outcome [4]
451507
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Feasibility of the implementation strategies: The extent to which the implementation strategies can be successfully used in existing stroke and cardiac rehabilitation settings.
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Assessment method [4]
451507
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Quantitative survey data from the Feasibility of Intervention Measure (FIM). Data collection will also include qualitative, semi-covert observations of how implementation strategies are used during referral and program delivery, guided by a structured template. In addition, semi-structured interviews will be conducted with clinicians individually via phone or Microsoft Teams, each lasting approximately 30 minutes. These interviews will be audio-recorded and professionally transcribed. Field notes will also be maintained to capture contextual details and researcher reflections throughout the process.
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Timepoint [4]
451507
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Mid-way through the implementation strategy intervention evaluation period (6-months following roll-out of the implementation strategies, phase 3). At the end of implementation strategy intervention evaluation period (12 months following roll-out of the implementation strategies, phase 3) (survey only conducted at the end and not mid-way).
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Secondary outcome [5]
451516
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Fidelity of the implementation strategies: The degree to which the implementation strategies were utilised as intended.
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Assessment method [5]
451516
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Data collection will include qualitative notes recorded in the resources and training log, qualitative, semi-covert observations of how implementation strategies are used during referral and program delivery, guided by a structured template. In addition, semi-structured interviews will be conducted with clinicians individually via phone or Microsoft Teams, each lasting approximately 30 minutes. These interviews will be audio-recorded and professionally transcribed. Field notes will also be maintained to capture contextual details and researcher reflections throughout the process. notes recorded in the resources and training log.
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Timepoint [5]
451516
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During delivery of the implementation strategy intervention to clinicians (over 3-months during phase 2) (only notes recorded in the resources and training log will be collected at this timepoint) Mid-way through the implementation strategy intervention evaluation period (6-months following roll-out of the implementation strategies, phase 3). At the end of implementation strategy intervention evaluation period (12 months following roll-out of the implementation strategies, phase 3)
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Secondary outcome [6]
451517
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Cost of the implementation strategies: The cost of the implementation strategies used to support referral to and delivery of the integrated cardiac rehabilitation program within existing health service structures.
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Assessment method [6]
451517
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Implementation costs will be recorded prospectively using time-driven activity costs recorded in the resources and training log. This will include direct costs of the implementation strategies (i.e. physical resources, room booking) and time to deliver the strategies, converted into monetary values using standard salary rates for attendees and presenters.
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Timepoint [6]
451517
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During delivery of the implementation strategy intervention to clinicians (over 3-months during phase 2) (only notes recorded in the resources and training log will be collected at this timepoint) Throughout the implementation strategy intervention evaluation period (up to 12-months following roll-out of the implementation strategies, phase 3) so as to accurately record any further training costs incurred throughout this period.
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Secondary outcome [7]
451518
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Penetration of the implementation strategies: The integration of the implementation strategies within the stroke service and cardiac rehabilitation clinical settings.
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Assessment method [7]
451518
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Data collection will include qualitative, semi-covert observations of how implementation strategies are used during referral and program delivery, guided by a structured template. In addition, semi-structured interviews will be conducted with clinicians individually via phone or Microsoft Teams, each lasting approximately 30 minutes. These interviews will be audio-recorded and professionally transcribed. Field notes will also be maintained to capture contextual details and researcher reflections throughout the process.
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Timepoint [7]
451518
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Mid-way through the implementation strategy intervention evaluation period (6-months following roll-out of the implementation strategies, phase 3). At the end of implementation strategy intervention evaluation period (12 months following roll-out of the implementation strategies, phase 3)
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Eligibility
Key inclusion criteria
Participants will be recruited during phase 1 and 3 of the study.
Eligibility - Phase 1:
- Eligible clinicians and managers must be employed within the stroke services or outpatient cardiac rehabilitation at either North Canberra Hospital (NCH) or The Canberra Hospital (TCH) during October 2025 – December 2025.
- Eligible consumers must have lived experience of TIA or mild stroke.
Eligibility - Phase 3:
- Eligible clinicians must be employed within the stroke services or outpatient cardiac rehabilitation at either site during the study period (March 2026 – April 2027), and be actively involved in referral or delivery of cardiac rehabilitation for people with TIA or mild stroke.
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Minimum age
18
Years
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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?
Yes
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Key exclusion criteria
None
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 0
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Type of endpoint/s
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Statistical methods / analysis
A mixed-methods evaluation of processes and outcomes will be conducted, involving quantitative and qualitative data analysis.
Quantitative hospital administrative data, implementation intervention cost, demographic characteristics and outcomes from the surveys will be analysed by the two lead investigators using descriptive statistics with appropriate statistical software. Continuous variables will be summarised using means and standard deviations (SD) or medians with interquartile ranges (IQR) or ranges, as appropriate. Categorical variables will be reported as frequencies and percentages. For cost, equipment and materials resources costs, total labour time, labour time per site, and associated monetary values will be calculated.
Qualitative data will be analysed deductively using framework analysis. Throughout phase 1 qualitative data, alongside findings from our previous ACT Health funded type I hybrid trial, will be mapped to the Theoretical Domains Framework (TDF) and the Expert Recommendations for Implementing Change (ERIC) matching tool. Throughout phase 3, qualitative data evaluating the use of the implementation intervention will be deductively mapped to the Consolidated Framework for Implementation Research (CFIR). A priori codebook will developed to guide deductive framework analysis. Data will be analysed by two researchers trained and experienced in qualitative research, following the five stages of framework analysis.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
22/09/2025
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Actual
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Date of last participant enrolment
Anticipated
17/05/2027
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Actual
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Date of last data collection
Anticipated
28/05/2027
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT
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Recruitment postcode(s) [1]
44609
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2617 - Bruce
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Recruitment postcode(s) [2]
44610
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2605 - Garran
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Funding & Sponsors
Funding source category [1]
319797
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Hospital
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Name [1]
319797
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Canberra Health Services
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Address [1]
319797
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Country [1]
319797
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Australia
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Funding source category [2]
319798
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University
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Name [2]
319798
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University of Canberra Health Research Institute
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Address [2]
319798
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Country [2]
319798
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Australia
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Primary sponsor type
Individual
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Name
Lucy Walton, University of Canberra and Canberra Health Services
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Address
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Country
Australia
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Secondary sponsor category [1]
322313
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Individual
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Name [1]
322313
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Nicole Freene, University of Canberra
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Address [1]
322313
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Country [1]
322313
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318356
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ACT Health Human Research Ethics Committee
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Ethics committee address [1]
318356
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https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
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Ethics committee country [1]
318356
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Australia
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Date submitted for ethics approval [1]
318356
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25/08/2025
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Approval date [1]
318356
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03/09/2025
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Ethics approval number [1]
318356
0
Regis reference: 2025/ETH01796, ACT Reference: 2025.LRE.00235
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Summary
Brief summary
One in four strokes in Australia are repeat events. These repeat strokes are more likely to result in death and are costly, for both individuals and the healthcare system. Cardiac rehabilitation is a well-established, evidenced-based and widely available secondary prevention program that reduces disease risk and death from heart disease and could help prevent repeat strokes as both share similar risk factors. This 2-year pilot implementation trial will uses a pre-post trial design, conducted within the Canberra Health Service (Canberra and North Canberra Hospitals). The multi-component implementation strategy intervention will first be developed using implementation frameworks, data from our randomized trial and in consultation with stakeholders (stroke and cardiac rehabilitation clinicians, managers, patients). We will then assess the effectiveness of the implementation strategies (e.g., Digital Health Record (DHR) referral, clinician training) for improving clinician referral and delivery of cardiac rehabilitation to people who have had a TIA or mild stroke over 12-months. Implementation outcome (i.e., number people with TIA or mild stroke referred, commenced and completed the program) and process measures will be collected using hospital administrative data, clinician interviews, surveys, and observations of the clinical context. Results will guide the implementation of this novel program on a larger scale, identifying solutions to address the research-to-practice gap, rarely included in efficacy or effectiveness trials.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
143922
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Miss Lucy Walton
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Address
143922
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University of Canberra, University Drive, Bruce, ACT, 2617
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Country
143922
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Australia
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Phone
143922
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+61 488964402
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Fax
143922
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Email
143922
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[email protected]
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Contact person for public queries
Name
143923
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Lucy Walton
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Address
143923
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University of Canberra, University Drive, Bruce, ACT, 2617
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Country
143923
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Australia
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Phone
143923
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+61 488964402
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Fax
143923
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Email
143923
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[email protected]
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Contact person for scientific queries
Name
143924
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Lucy Walton
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Address
143924
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University of Canberra, University Drive, Bruce, ACT, 2617
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Country
143924
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Australia
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Phone
143924
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+61 488964402
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Fax
143924
0
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Email
143924
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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