Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000540516
Ethics application status
Approved
Date submitted
28/03/2024
Date registered
30/04/2024
Date last updated
30/04/2024
Date data sharing statement initially provided
30/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Love Your Brain: A Digital Platform for Preventing Stroke [Stage 2: Pilot]
Scientific title
Implementation of the Love Your Brain stroke prevention digital platform through a feasibility pilot trial in healthy adults
Secondary ID [1] 311612 0
Nil known
Universal Trial Number (UTN)
U1111-1305-2964
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 333033 0
Condition category
Condition code
Public Health 329716 329716 0 0
Health promotion/education
Cardiovascular 330136 330136 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this feasibility pilot trial we aim to test the feasibility and acceptability of implementing the Love Your Brain digital platform for stroke prevention, through a randomised controlled trial. The Love Your Brain digital platform comprises access to a massive open online course (MOOC), text messages (via email or SMS), or a minimal control arm over a period of 12 weeks following attendance at a Stroke Foundation StrokeSafe presentation. 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. The 12 week survey will additionally ask about the benefits of participation, ease of use, facilitators and barriers, engagement (12-week duration, timing of communication, time allocated, linked resources), and satisfaction. Baseline and 12-week surveys should take around 25-30 minutes to complete.
Participants randomised to one of the two intervention groups (MOOC and 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.
MOOC
To complete the MOOC, participants must complete seven core modules, and at least two (of nine) elective modules over the 12 week intervention period. 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.
TEXT MESSAGES
Participants in the text message arm will receive between 28 and 58 text messages over the 12 week intervention period, and these will be sent via email or SMS based on the preference indicated in the baseline survey. Participants will be offered the opportunity to change their preferences at any time during the 12 weeks.
Intervention code [1] 328063 0
Prevention
Intervention code [2] 328064 0
Lifestyle
Intervention code [3] 328065 0
Behaviour
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, with one reminder message sent one week later,
Control group
Active

Outcomes
Primary outcome [1] 337525 0
Number of participants that complete the trial
Timepoint [1] 337525 0
12 weeks post randomisation
Primary outcome [2] 337526 0
Number of participants satisfied with the digital platform
Timepoint [2] 337526 0
12 weeks post randomisation
Secondary outcome [1] 432206 0
Group differences in General Practitioner attendance for a comprehensive risk factor assessment, or Heart Health Check
Timepoint [1] 432206 0
12 weeks post randomisation
Secondary outcome [2] 432207 0
Group differences in medication adherence
Timepoint [2] 432207 0
12 weeks post randomisation
Secondary outcome [3] 432208 0
Group differences in uptake of healthy or risk-modifying behaviours
Timepoint [3] 432208 0
12 weeks post randomisation
Secondary outcome [4] 432209 0
Group differences in knowledge of signs of stroke and risk factors of stroke
Timepoint [4] 432209 0
12 weeks post randomisation

Eligibility
Key inclusion criteria
The Love Your Brain digital platform will be offered to people completing the Stroke Foundation’s nationwide StrokeSafe presentations.
Inclusion criteria:
• No history of stroke or other major cardiovascular event (self-reported; includes heart attack/myocardial infarction, coronary artery bypass surgery)
• Aged at least 18 years
• Able to communicate in English
• Residing in Australia
• Able to access the internet (via home device or phone)
• Have an email address and are familiar with using the internet.
Minimum age
18 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)
Simple randomisation (1:1:1 ratio to each arm) stratified by age (<65, or >=65 years), and sex (male, female, or non-binary/gender diverse/prefer not to say) will be conducted using a randomisation table created by Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We have nominated a pragmatic sample size (n<150, with approximately equal in each arm) suitable for a feasibility study and similar to that used in other pilot work in this area. It is anticipated that we will be able to obtain sufficient information from this sample size to determine if our intervention is acceptable and feasible whilst also providing some early signals for effectiveness related to behaviour change for stroke prevention.
Primary analysis will use intention to treat analysis i.e. participants will be analysed in the treatment group to which they were randomised regardless of whether or not they received the intervention. A secondary per-protocol analysis will also be performed in which only those who completed the treatment to which they were originally allocated will be analysed. Success in visiting a GP for evaluation of stroke risk factors, achieving positive health related changes, and adherence to stroke prevention medication between intervention and minimal control groups will be assessed to provide preliminary evidence for a larger, fully powered RCT.
Descriptive statistics will be used to describe the trial population at baseline. Within group changes will be examined using McNemar’s test and between group differences will be examined using parametric or non-parametric methods appropriate to the distribution of the data. Where feasible, multivariable statistical models will also be used to adjust for baseline differences between the intervention and control groups for baseline variables with a p-value of <0.2.
The intervention engagement of participants (e.g. the number of times web-links were clicked, completion of MOOC modules) will also be assessed.
The quantitative and qualitative data will be used to fine-tune the intervention. As part of this process the findings from each aspect of the project will be triangulated as part of the interpretative process. Triangulation is the combination of at least two or more theoretical perspectives, methodological approaches, data sources, investigators, or data analysis methods. The intent of using triangulation is to decrease, negate, or counterbalance the deficiency of a single strategy, thereby increasing the ability to interpret the findings. This is particularly useful in pilot studies whereby formative program evaluation techniques as outlined in this study are being used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2024
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
3/11/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316030 0
Government body
Name [1] 316030 0
Department of Health and Aged Care: Medical Research Future Fund (MRFF)
Country [1] 316030 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318183 0
None
Name [1] 318183 0
Address [1] 318183 0
Country [1] 318183 0
Other collaborator category [1] 282973 0
University
Name [1] 282973 0
The Menzies Institute for Medical Research, University of Tasmania
Address [1] 282973 0
Country [1] 282973 0
Australia
Other collaborator category [2] 282974 0
Charities/Societies/Foundations
Name [2] 282974 0
Stroke Foundation
Address [2] 282974 0
Country [2] 282974 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314765 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314765 0
https://www.monash.edu/researchoffice/ethics
Ethics committee country [1] 314765 0
Australia
Date submitted for ethics approval [1] 314765 0
19/12/2023
Approval date [1] 314765 0
03/01/2024
Ethics approval number [1] 314765 0
2023-41176-102019

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 to improve the knowledge of Australians in stroke prevention, by helping people identify and manage their risk factors for stroke. We will determine the feasibility and acceptance of the implementation of the proposed intervention in a sample of attendees of Stroke Foundation StrokeSafe presentations and obtain data to inform the design of a fully powered randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132658 0
A/Prof Monique Kilkenny
Address 132658 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 132658 0
Australia
Phone 132658 0
+61 3 7511 1861
Fax 132658 0
Email 132658 0
monique.kilkenny@monash.edu
Contact person for public queries
Name 132659 0
Monique Kilkenny
Address 132659 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 132659 0
Australia
Phone 132659 0
+61 3 7511 1861
Fax 132659 0
Email 132659 0
monique.kilkenny@monash.edu
Contact person for scientific queries
Name 132660 0
Monique Kilkenny
Address 132660 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 132660 0
Australia
Phone 132660 0
+61 3 7511 1861
Fax 132660 0
Email 132660 0
monique.kilkenny@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.