Methods in Neuroepidemiology Neuroepidemiology The Effectiveness of Stroke Riskometer™ in Improving Stroke Risk Awareness in Malaysia: A Study Protocol of a Cluster-Randomized Controlled Trial Zarudin Mat Said a Kamarul Imran Musa a Tengku Alina Tengku Ismail a Anees Abdul Hamid b Ramesh Sahathevan c Zariah Abdul Aziz d Valery Feigin e a Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Health Campus, Kubang Kerian, Malaysia; b Primary Care Unit, Kelantan State Health Department, Kota Bharu, Malaysia; c Department of Medicine and Neurology, Ballarat Health Services, Ballarat, VIC, Australia; d Department of Medicine, Hospital Sultanah Nur Zahirah, Kuala Terengganu, Malaysia; e National Institute for Stroke and Applied Neurosciences, Auckland University of Technology (AUT), Auckland City, New Zealand Received: February 6, 2021 Accepted: August 3, 2021 Published online: September 15, 2021 Correspondence to: Kamarul Imran Musa, drkamarul @usm.my © 2021 S. Karger AG, Basel karger@karger.com www.karger.com/ned DOI: 10.1159/000518853 Keywords Stroke · Risk probability · Awareness · Mobile applications · mHealth Abstract Background: Stroke is considered the second leading cause of mortality and disability worldwide. The increasing burden of stroke is strong evidence that currently used primary pre- vention strategies are not sufficiently effective. The Stroke Riskometer ™ application (app) represents a new stroke pre- vention strategy distinctly different from the conventional high-cardiovascular disease risk approach. Objective: This proposed study aims to evaluate the effectiveness of the Stroke Riskometer ™ app in improving stroke awareness and stroke risk probability amongst the adult population in Ma- laysia. Methods: A non-blinded, parallel-group cluster-ran- domized controlled trial with a 1:1 allocation ratio will be implemented in Kelantan, Malaysia. Two groups with a sam- ple size of 66 in each group will be recruited. The interven- tion group will be equipped with the Stroke Riskometer ™ app and informational leaflets, while the control group will be provided with standard management, including informa- tion leaflets only. The Stroke Riskometer ™ app was devel- oped according to the self-management model of chronic diseases based on self-regulation and social cognitive theo- ries. Data collection will be conducted at baseline and on the third week, sixth week, and sixth month follow-up via tele- phone interview or online questionnaire survey. The primary outcome measure is stroke risk awareness, including the do- mains of knowledge, perception, and intention to change. The secondary outcome measure is stroke risk probability within 5 and 10 years adjusted to each participant’s socio- demographic and/or socio-economic status. An intention- to-treat approach will be used to evaluate these measures. Pearson’s χ 2 or independent t test will be used to examine differences between the intervention and control groups. The generalized estimating equation and the linear mixed- effects model will be employed to test the overall effective- ness of the intervention. Conclusion: This study will evaluate the effect of Stroke Riskometer ™ app on stroke awareness and stroke probability and briefly evaluate participant en-