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Trial registered on ANZCTR
Registration number
ACTRN12625000124437
Ethics application status
Approved
Date submitted
8/01/2025
Date registered
4/02/2025
Date last updated
4/02/2025
Date data sharing statement initially provided
4/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Love Your Brain: A Digital Platform for Preventing Stroke [Stage 3: Randomised Controlled Trial]
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Scientific title
Implementation of the Love Your Brain stroke prevention digital platform through an effectiveness Randomised Controlled Trial with process evaluation and economic evaluation in Australians aged 45 years and over without a major cardiovascular event .
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Secondary ID [1]
313646
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Nil known
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Universal Trial Number (UTN)
U1111-1305-2964
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Trial acronym
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Linked study record
This record is a randomised control trial of the feasibility study ACTRN12624000540516.
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Health condition
Health condition(s) or problem(s) studied:
Stroke
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Condition category
Condition code
Cardiovascular
332746
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0
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Other cardiovascular diseases
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Public Health
332745
332745
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0
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Health promotion/education
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Neurological
332905
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The Love Your Brain digital platform comprises access to an online course, text messages (via SMS or email), or a minimal control arm over a period of 12 weeks following a Stroke Foundation StrokeSafe presentation (online or in-person). All participants will complete a survey at baseline to identify risk factors for stroke they would like to learn more about over 12 weeks. Participants will then be randomised to one of the three arms. Following the 12 week intervention period, participants will receive a link to the 12-week completion survey and evaluation survey. Baseline and 12-week surveys should take around 20 minutes to complete.
Participants randomised to one of the two intervention groups (online course or text messages) will receive 12 weeks of information about stroke including definition and epidemiology of stroke, signs of stroke, a general overview of risk factors for stroke, specific information about risk factors for stroke chosen by the participant, and an action plan.
ONLINE COURSE
To complete the online course, participants must complete seven core modules, and at least two (of nine) elective modules over the 12 week intervention period. Modules are self-paced and to be completed within eight weeks of initiating the first module.
Core modules are 1. Introduction, 2. What is Stroke, 3. Stroke Numbers, 4. Signs of stroke - F.A.S.T, 5. Risk factors for stroke, 6. Action Plan, and 7. Completion Module. Each participant will then elect (or be guided based on the baseline survey responses) to complete at least one module based on biomedical risk factors for stroke (specifically either Blood Pressure, Cholesterol, Atrial Fibrillation, Overweight & obesity, Blood sugar & diabetes); and at least one module based on lifestyle-based behavioural risk factors for stroke (specifically Smoking, Diet & Alcohol, Exercise, Sleep & wellbeing). Modules include short videos with transcripts, text, links to further information, and knowledge quizzes. Module duration ranges between 30 minutes to 1 hour, with the complete course being achievable in 4 hours.
Online course initiation, progress and completion will be monitored. Online course analytics include
• Amount (dose) of the intervention delivered (measured by the time spend engaging with the online course, or time spent self-reported in the 12-week survey)
• Number of participants who started, completed or failed to complete the online course
• Metrics pertaining to the intervention arm engagement (e.g. link clicks, online course quiz completions).
TEXT MESSAGES
Participants in the text message arm will receive between 28 and 58 text messages over the 12 week intervention period. The text messages are in plain language with the vast majority (98%) receiving a readability index of Grade 10 or less (79% <=Grade 8). Links to additional resources are provided in some messages. The majority of text messages are the typical length of 160 characters. However, a few are longer and may appear as two messages sent one second after the other. Text message content has two elements: core information and healthier choices.
Core information is received by all participants, and includes administration (Introduction/Completion), Stroke numbers, What is stroke, Signs of stroke, Impact, Risk factors for stroke, and Action plan.
Healthier choices is personalised to the participants. The number of healthier choices the participant chooses in the baseline survey will determine the number of text messages they receive (e.g. participants who choose to learn more about one healthier choice receive messages twice per week). Risk factors will be ranked on a hierarchy of selection based on the population attributable risk. Participants will be offered the opportunity to change their preferences at any time during the 12 weeks. Options include: Control blood pressure, Start exercising and keep active, Control cholesterol, Healthy eating, Achieve and maintain a healthy weight, Quit and stay smoke free, Be informed and manage atrial fibrillation, Drink less alcohol, Control blood sugar, and Improve wellbeing and get enough sleep.
Documentation and metrics will be used to monitor participants, including:
• Amount (dose) of the intervention delivered (measured by the number of text messages received per week, or time spent self-reported in the 12-week survey)
• Number of SMS messages that failed to send
• Metrics pertaining to the intervention arm engagement (e.g. link clicks)
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Intervention code [1]
330243
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Behaviour
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Intervention code [2]
330242
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Lifestyle
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Intervention code [3]
330241
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Prevention
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Comparator / control treatment
Participants randomised to the minimal control arm will receive three administrative emails (welcome, invitation to complete the 12-week survey, and thank you), and five generic emails about risk factors for stroke and links to information on the Stroke Foundation website. These emails will be delivered approximately every fortnight. Following the 12 week trial period, participants will receive a link to the 12-week completion survey and evaluation survey.
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Control group
Active
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Outcomes
Primary outcome [1]
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Visits to a medical practitioner for cardiovascular risk assessment and management from either a GP or specialist
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Assessment method [1]
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Self-report: Self-reported primary outcome data will be obtained via the baseline and 12-week completion surveys for analysis prior to the linked data, which will occur at the end of the trial. Linked medical records: Self-report will be validated using relevant Medical Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) codes.
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Timepoint [1]
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For self-report: Follow-up survey conduced after the three-month intervention period. For linked data: within 3 months of randomisation
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Secondary outcome [1]
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The maintenance and uptake of healthy or risk-modifying behaviours
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Assessment method [1]
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Self-report: Uptake of at least one of the following healthy or risk-modifying behaviours: Physical activity: Physically active is defined as self-reported 30 minutes or more of moderate-intensity physical activity, or 20 minutes or more of vigorous-intensity physical activity, at least 3 times a week. Diet: self-reported Mini-EATS score with healthy eating score of >69 Weight: Not overweight is defined as self-reported body mass index of <25 Smoking cessation: Does not currently smoke tobacco. Alcohol consumption: self-reported <10 standard drinks per week, or <4 standard drinks per day Sleep and wellbeing: self-reported EQ-5D-5L-psychosocial with absence of problems with energy, close relationships, sleep and social isolation.
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Timepoint [1]
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Follow-up survey conduced after the three-month intervention period.
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Secondary outcome [2]
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Adherence to medications
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Assessment method [2]
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Self-report: Measured using the Medication Adherence Report Scale-5 Linked medical records: self-report validated using the PBS data.
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Timepoint [2]
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For self-report: Follow-up survey conduced after the three-month intervention period. For linked data: within 3 months of randomisation
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Secondary outcome [3]
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Cost-effectiveness economic evaluation
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Assessment method [3]
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To determine the potential cost-effectiveness of Love Your Brain we will summarise the program delivery costs and the costs to participants. The costs of providing the project and intervention arms will be based on information collected for the operational costs associated with the delivery of the interventions as tracked in relevant finance reports, and will include the costs of consumables and presenters, as well as the relevant Stroke Foundation staff. Unit prices for resources used by participants will be obtained from the most relevant and contemporary Australian sources.
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Timepoint [3]
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At the conclusion of the study.
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Secondary outcome [4]
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Number of participants that complete the trial
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Assessment method [4]
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Produce complementary evidence from a process evaluation to support replication in other settings/contexts: Sourced from study records in Research Electronic Data Capture - REDCap: - Number of participants who were recruited that completed each intervention arm - Completeness of surveys - Number of withdrawals University of Tasmania's Massive Online Open Course on Stroke (intervention arm): - Online course analytics.
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Timepoint [4]
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Follow-up survey conduced after the three-month intervention period.
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Secondary outcome [5]
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Number of participants satisfied with the digital platform
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Assessment method [5]
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Produce complementary evidence from a process evaluation to support replication in other settings/contexts: Using a study specific questionnaire with a combination of questions seeking responses on a 5 point Likert scale and open ended questions.
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Timepoint [5]
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Follow-up survey conducted after the three-month intervention period.
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Secondary outcome [6]
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"Stroke knowledge" will be assessed as a composite outcome, pertaining to knowledge of signs and risk factors for stroke.
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Assessment method [6]
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Any change in stroke knowledge: knowledge of signs and risk factors for stroke, measured using the Stroke Knowledge Test incorporating stroke risk, warning signs and appropriate behaviour.
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Timepoint [6]
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Follow-up survey conduced after the three-month intervention period.
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Eligibility
Key inclusion criteria
• No history of stroke or other major cardiovascular event (self-reported; includes heart attack/myocardial infarction, coronary artery bypass surgery)
• Aged 45 years and over
• Able to communicate in English
• Residing in Australia
• Able to access the internet and a smartphone
• Have watched a StrokeSafe presentation (in-person or online) in the last three months
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Minimum age
45
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
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer. Allocation concealment will be conducted using the randomisation module in REDCap (https://cri.uchicago.edu/wp-content/uploads/2020/02/REDCap-Randomization-Module.pdf)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into the three intervention arms in 1:1:1 ratio. Randomisation will be undertaken through the REDCap, with stratification balancing by age (45 years to less than 65, 65 years or more) and gender (man, woman, non-binary/gender diverse/prefer not to say).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The statistical analysis plan is intended to be published separately. The primary analysis will use intention to treat analysis and a secondary per-protocol analysis will also be performed. The two intervention arms will each be compared to the one minimal active control arm. A direct comparison between the text message intervention and the online course intervention is not intended, as both will be available concurrently in real-world settings.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/02/2025
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Actual
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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
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Actual
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Sample size
Target
894
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Department of Health and Aged Care: Medical Research Future Fund (MRFF)
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Address [1]
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Country [1]
318113
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
320492
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Other collaborator category [1]
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University
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Name [1]
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The Menzies Institute for Medical Research, University of Tasmania
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Address [1]
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Country [1]
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Australia
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Other collaborator category [2]
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Charities/Societies/Foundations
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Name [2]
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Stroke Foundation
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Address [2]
283348
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Country [2]
283348
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316758
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
316758
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
316758
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Australia
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Date submitted for ethics approval [1]
316758
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19/12/2024
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Approval date [1]
316758
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14/01/2025
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Ethics approval number [1]
316758
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45883
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Summary
Brief summary
Stroke affects approximately 1 in 4 people in their lifetime, but is highly preventable through effective management of risk factors such as smoking, inadequate diet, high blood pressure and physical inactivity. Love Your Brain is a digital platform that aims to help people identify and manage their risk factors for stroke. There are three sequential stages of the Love Your Brain digital platform development and evaluation: Co-design (Stage 1), Implement (Stage 2), and Evaluate (Stage 3). This Stage 3 trial will evaluate whether Love Your Brain helps people identify and manage their risk factors, for example: by seeing a medical practitioner (GP or specialist) for assessment or management of their risk factors; having increased knowledge of risk factors and signs of stroke; and adopting healthy behaviours for controlling risk factors of stroke. We hypothesise that participating in Love Your Brain will improve stroke knowledge, leading to more discussions with healthcare professionals and prevention of stroke in Australia.
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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
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Prof Monique Kilkenny
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Address
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Big Data, Epidemiology and Prevention Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, 631 Blackburn Road, Clayton VIC 3168
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Country
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Australia
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Phone
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+61 3 7511 1861
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Monique Kilkenny
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Address
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Big Data, Epidemiology and Prevention Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, 631 Blackburn Road, Clayton VIC 3168
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Country
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Australia
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Phone
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+61 3 7511 1861
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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
Name
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Monique Kilkenny
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Address
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Big Data, Epidemiology and Prevention Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, 631 Blackburn Road, Clayton VIC 3168
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Country
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Australia
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Phone
138920
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+61 3 7511 1861
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Fax
138920
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Email
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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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