Trial Review

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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]
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 .
Secondary ID [1] 313646 0
Nil known
Universal Trial Number (UTN)
U1111-1305-2964
Trial acronym
Linked study record
This record is a randomised control trial of the feasibility study ACTRN12624000540516.

Health condition
Health condition(s) or problem(s) studied:
Stroke 336213 0
Condition category
Condition code
Cardiovascular 332746 332746 0 0
Other cardiovascular diseases
Public Health 332745 332745 0 0
Health promotion/education
Neurological 332905 332905 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 330243 0
Behaviour
Intervention code [2] 330242 0
Lifestyle
Intervention code [3] 330241 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 340278 0
Visits to a medical practitioner for cardiovascular risk assessment and management from either a GP or specialist
Timepoint [1] 340278 0
For self-report: Follow-up survey conduced after the three-month intervention period. For linked data: within 3 months of randomisation
Secondary outcome [1] 443581 0
The maintenance and uptake of healthy or risk-modifying behaviours
Timepoint [1] 443581 0
Follow-up survey conduced after the three-month intervention period.
Secondary outcome [2] 443582 0
Adherence to medications
Timepoint [2] 443582 0
For self-report: Follow-up survey conduced after the three-month intervention period. For linked data: within 3 months of randomisation
Secondary outcome [3] 444047 0
Cost-effectiveness economic evaluation
Timepoint [3] 444047 0
At the conclusion of the study.
Secondary outcome [4] 443585 0
Number of participants that complete the trial
Timepoint [4] 443585 0
Follow-up survey conduced after the three-month intervention period.
Secondary outcome [5] 443587 0
Number of participants satisfied with the digital platform
Timepoint [5] 443587 0
Follow-up survey conducted after the three-month intervention period.
Secondary outcome [6] 443580 0
"Stroke knowledge" will be assessed as a composite outcome, pertaining to knowledge of signs and risk factors for stroke.
Timepoint [6] 443580 0
Follow-up survey conduced after the three-month intervention period.

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
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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)
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
894
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318113 0
Government body
Name [1] 318113 0
Department of Health and Aged Care: Medical Research Future Fund (MRFF)
Country [1] 318113 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320492 0
None
Name [1] 320492 0
Address [1] 320492 0
Country [1] 320492 0
Other collaborator category [1] 283347 0
University
Name [1] 283347 0
The Menzies Institute for Medical Research, University of Tasmania
Address [1] 283347 0
Country [1] 283347 0
Australia
Other collaborator category [2] 283348 0
Charities/Societies/Foundations
Name [2] 283348 0
Stroke Foundation
Address [2] 283348 0
Country [2] 283348 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316758 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 316758 0
Ethics committee country [1] 316758 0
Australia
Date submitted for ethics approval [1] 316758 0
19/12/2024
Approval date [1] 316758 0
14/01/2025
Ethics approval number [1] 316758 0
45883

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138918 0
Prof Monique Kilkenny
Address 138918 0
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
Country 138918 0
Australia
Phone 138918 0
+61 3 7511 1861
Fax 138918 0
Email 138918 0
[email protected]
Contact person for public queries
Name 138919 0
Monique Kilkenny
Address 138919 0
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
Country 138919 0
Australia
Phone 138919 0
+61 3 7511 1861
Fax 138919 0
Email 138919 0
[email protected]
Contact person for scientific queries
Name 138920 0
Monique Kilkenny
Address 138920 0
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
Country 138920 0
Australia
Phone 138920 0
+61 3 7511 1861
Fax 138920 0
Email 138920 0
[email protected]

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.