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Love Your Brain: A Digital Platform for Preventing Stroke [Stage 3: Randomised Controlled Trial]

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 .

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000124437
Enrollment
941
Registered
2025-02-04
Start date
2025-02-18
Completion date
2025-09-17
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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)

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
Yes

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

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026