Background: The Stroke Riskometer mobile phone app (the App) uses individual demographic, health, and lifestyle data to provide personalised information to modify stroke risk factors. The PERKS-International RCT is testing the App, compared to usual care group not informed about the App, to explore its effectiveness in reducing a stroke risk factor score at 6 months after randomisation.
Aim: To report on progress of recruitment, characteristics of participants and follow-up in this ongoing RCT.
Methods: This Phase III single-blinded endpoint 2 arm RCT is recruiting 790 participants across Australia and New Zealand (5 sites). Inclusion criteria: >35 and ≤75 years, 2+ modifiable risk factors, no history of stroke/CVD/dementia and owns a smartphone. Participants are recruited via social media (Australia + NZ) and primary care (NZ) with self-screening online for eligibility with minimal contact with study staff. Assessments are conducted face-to-face at baseline and 6 months. The primary outcome is a combined behaviour and biomedical stroke risk score (range 0 [no healthy risk factors] to 7 [all healthy risk factors]) at 6 months. We examined (n, %) the completeness of screening, eligibility, randomisation and primary outcome assessment to date.
Results: Recruitment began in Australia in August 2021 and in New Zealand in March 2022. The COVID-19 pandemic has impacted recruitment several times. The screening website has been visited by 2,564 people, with 80% completing screening and 48% eligible to participate. Of those eligible, 504 (41%) people have been randomised with mean (SD) age 58.4 (10.8), 62% women, 65% tertiary educated, and 75% white/European ethnicity. The 6-month primary outcome assessment has been completed by 97% of participants.
Conclusion: Online self-screening requires minimal staff input but only 40% of eligible participants have continued to randomisation. Recruitment will conclude in September 2023 with primary outcome data available in May 2024.