Supplementary Material for: The Effectiveness of Stroke Riskometer™ in Improving Stroke Risk Awareness in Malaysia: A Study Protocol of a Cluster-Randomized Controlled Trial

<b><i>Background:</i></b> Stroke is considered the second leading cause of mortality and disability worldwide. The increasing burden of stroke is strong evidence that currently used primary prevention strategies are not sufficiently effective. The Stroke Riskometer^™ application (app) represents a new stroke prevention strategy distinctly different from the conventional high-cardiovascular disease risk approach. <b><i>Objective:</i></b> 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 Malaysia. <b><i>Methods:</i></b> A non-blinded, parallel-group cluster-randomized controlled trial with a 1:1 allocation ratio will be implemented in Kelantan, Malaysia. Two groups with a sample size of 66 in each group will be recruited. The intervention group will be equipped with the Stroke Riskometer^™ app and informational leaflets, while the control group will be provided with standard management, including information leaflets only. The Stroke Riskometer^™ app was developed according to the self-management model of chronic diseases based on self-regulation and social cognitive theories. Data collection will be conducted at baseline and on the third week, sixth week, and sixth month follow-up via telephone interview or online questionnaire survey. The primary outcome measure is stroke risk awareness, including the domains 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 χ² or independent <i>t</i> 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 effectiveness of the intervention. <b><i>Conclusion:</i></b> This study will evaluate the effect of Stroke Riskometer^™ app on stroke awareness and stroke probability and briefly evaluate participant engagement to a pre-specified trial protocol. The findings from this will inform physicians and public health professionals of the benefit of mobile technology intervention and encourage more active mobile phone-based disease prevention apps. <b><i>Trial Registration:</i></b> ClinicalTrials.gov Identifier NCT04529681.

背景：脑卒中被认为是全球范围内第二大致死与致残病因。脑卒中负担日益加重，充分印证了当前主流的一级预防策略尚未达到足够理想的防控效果。脑卒中风险计算器（Stroke Riskometer™）应用程序代表了一种区别于传统心血管疾病高危风险防控模式的新型脑卒中预防策略。
目的：本拟开展的研究旨在评估脑卒中风险计算器（Stroke Riskometer™）应用程序在提升马来西亚成年人群脑卒中认知水平与脑卒中风险概率认知方面的防控效果。
方法：本研究将在马来西亚吉兰丹州开展一项设1:1随机分组比例的非盲平行整群随机对照试验。拟招募两组受试者，每组样本量均为66例。干预组将配备脑卒中风险计算器（Stroke Riskometer™）应用程序与健康宣传手册，对照组则仅接受标准健康管理服务，仅发放健康宣传手册。脑卒中风险计算器（Stroke Riskometer™）应用程序的开发基于自我调节与社会认知理论构建的慢性病自我管理模式。数据采集将在基线、随访第3周、第6周及第6个月时，通过电话访谈或线上问卷调查的方式完成。主要结局指标为脑卒中风险认知水平，涵盖知识储备、认知感知与行为改变意愿三个维度。次要结局指标为经受试者社会人口学及/或社会经济状况校正后的5年与10年脑卒中发生风险概率。本研究将采用意向性治疗分析法评估上述结局指标。将采用Pearson卡方检验或独立样本t检验比较干预组与对照组间的组间差异，并运用广义估计方程与线性混合效应模型评估干预措施的整体防控效果。
结论：本研究将评估脑卒中风险计算器（Stroke Riskometer™）应用程序对脑卒中认知水平及脑卒中风险概率的影响，并简要评估受试者对预先设定的试验方案的依从性。本研究结果将为临床医师及公共卫生专业人员阐明移动技术干预的获益价值，并推动更多基于移动设备的疾病预防类应用程序的开发与应用。
试验注册：ClinicalTrials.gov注册号为NCT04529681。