Blood pressure control in patients using the elfie self-monitoring and gamified mobile health application: a real-world evidence study involving over 22,000 users from 3 middle-income countries

Abstract Background Hypertension remains the leading global cause of mortality. Despite the availability of effective treatments, many patients fail to achieve adequate blood pressure (BP) control, often due to poor medication adherence. Mobile health (mHealth) applications offer a promising strategy to support hypertension management, yet evidence on their effectiveness across diverse populations and healthcare systems remains limited. Elfie is a comprehensive, self-monitoring, gamified freely available mHealth app that collects anonymized health data since 2021, currently deployed in multiple countries including Brazil, Turkey, and Vietnam, from which the data presented here are drawn. Objective To evaluate BP control and medication adherence among Elfie app users with hypertension in 3 middle-income countries. Methods This study is a multi-country, non-interventional, observational analysis using pooled, user-reported real-world data collected over 12 months. The population analysed met baseline criteria for hypertension with uncontrolled BP as defined by the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines (systolic BP (SBP) 130 mmHg or diastolic BP (DBP) 80 mmHg). Key outcomes included changes in mean SBP and DBP and self-reported adherence to medication over time. Results were analysed descriptively by prespecified timepoint and by absolute change from baseline. In addition, adjusted means of absolute change from baseline were assessed with a Mixed Model for Repeated Measures. Adjustments were performed according to predefined factors. Results A total of 22,901 individuals were included in this study. Half (50.7%) of the population was from Brazil, 37.1% from Vietnam and 12.2% from Turkey. Elfie users had a mean (SD) age of 49.5 (3.4) years and 51.9% were men. Over half (53.6 %) reported at least one concomitant disease, including dyslipidaemia (31.4%), diabetes (26.1%), and angina (12.7%), with a mean number of diseases per user of 1.72 (0.93). Mean reported SBP and DBP at baseline were 136.9 (16.3) mmHg and 86.7 (13.1) mmHg. By Month 1, 34.4% of patients had achieved BP control, and 51.6% by Month 12. Over this period, SBP decreased by 9.5 mmHg and DBP by 6.3 mmHg (p≤0.001) (Figure 1). Among patients with available reported drug data, month-to-month adherence to medication rates increased from 33.9% at Month 1 to 50.8% at Month 12 (p≤0.001) (Figure 2). Additionally, exploratory analyses showed significant association between chronic use of the app and reported adherence to medication over time: OR (CI 95%) 0.12 (0.11 ; 0.13). Conclusion In this real-world analysis involving 3 middle-income countries, significant improvements in BP control and reported adherence trends were observed in Elfie users over time. These findings may support the potential of a chronic use of the app in enhancing hypertension management.