None listed
Conditions
Brief summary
The PERKS-International trial, which has received funding from the Australian National Health and Medical Research Council (application ID APP1182071), will be of 4 years (2021-2024) duration and involve 790 participants who will be recruited and followed for at least 12 months. The Menzies Institute for Medical Research, University of Tasmania will be responsible for co-ordination of the PERKS-International trial. This is a Phase III, prospective, pragmatic, open-label, single blinded endpoint 2 arm randomised controlled trial (RCT) including 790 participants across Australia and New Zealand. Participants will be adults aged >35 and <=75 years with two or more modifiable risk factors (smoking, overweight, low physical activity, poor diet, high blood pressure, high total cholesterol or high blood glucose). Participants will be randomised using a stratified block approach to either the intervention or usual care group. After undergoing a detailed health assessment, participants will be randomised to receive feedback on their risk factors for stroke in one of two ways. Our hypothesis is that those who receive feedback using one method (intervention group - IG) will have better improvements in their risk factors as compared to people who receive the information about their risk factors using the other method (usual care group - UCG). Blinded assessments will be conducted face-to-face at baseline and 6 months and by online or telephone assessment at 3 and 12 months. The primary outcome is the change in the total combined cardiovascular risk factor score (LS7 score) from baseline to 6 months post-randomisation in the intervention group compared to usual care group.
Interventions
Participants in the intervention group (IG) will be provided with written information on their risk factors and provided with the links to download the Stroke Riskometer App. The written information is structured around Life's Simple Seven - (i) blood pressure, (ii) cholesterol, (iii) blood sugar, (iv) being active, (v) eating well, (vi) BMI and (vii) smoking. Individual indicators for each factor will be measured by online questionnaire and face-to-face health assessment. The written materials
Participants in the intervention group (IG) will be provided with written information on their risk factors and provided with the links to download the Stroke Riskometer App. The written information is structured around Life's Simple Seven - (i) blood pressure, (ii) cholesterol, (iii) blood sugar, (iv) being active, (v) eating well, (vi) BMI and (vii) smoking. Individual indicators for each factor will be measured by online questionnaire and face-to-face health assessment. The written materials have been developed for this study specifically. The Stroke Riskometer App guides users to input their personal risk factors and uses an in-built validated algorithm to show the users' relative and absolute risk of stroke in the next 5 or 10 years. Information on risk factors is saved within the App to allow tracking over time. The App provides personalised feedback on a user's modifiable (e.g. lifestyle and biomedical) and unmodifiable (e.g. age and sex) risk factors for stroke including evidence-based information on how to manage these risk factors in text and video format. There is also information on the signs and symptoms of stroke based on the Face, Arm, Speech, Time (FAST) acronym. The App uses 'push notifications' that automatically communicate with the user about the App at a decreasing frequency from first app use (e.g. daily, then weekly, then monthly). The App can be used to set specific goals to change risk factors including monitoring of change. Participants in the IG will complete a brief online questionnaire at 1 week after randomisation to confirm they have downloaded and entered their information into the app. The unblinded Project Manager will check-in with participants that do not complete the 1 week post-randomisation questionnaire or indicate that they are having issues with downloading or using the App. The App will be available to the Participants for the full 12 month duration of the trial, then indefinitely should they wish to continue to use the App.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged between 35 years to 75 years; 2. with 2 or more ‘poor’ risk factors on the LS7 scale; 3. no cognitive impairment (as determined by MoCA, score >26) 4. own a Smartphone and are familiar with the use of mobile phone applications; 5. give informed consent to participate in the trial; 6. Speak English and able to understand requirements of the study and information provided through a mobile phone application.
Exclusion criteria
1. History of stroke or myocardial infarction (self-report or verification through medical records when needed) 2. life-threatening conditions with a life-expectancy <5 years 3. participation in another RCT 4. family members of existing participants (or peers who reside in the same house).
Outcome results
None listed