A cluster-randomised controlled trial evaluating the effectiveness of stroke riskometer in improving stroke risk awareness in adults: a preliminary study.

Abstract

Background: Stroke is a global public health problem with significant burden, especially to the low- and middle-income countries. The Stroke Riskometer application (app) represents a new stroke prevention strategy that is distinctly different from the conventional high-cardiovascular disease (CVD) risk approach. Objectives: 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. Methods: The study was designed as a parallel-group non-blinded cluster-randomised controlled trial (RCT). It was conducted in Kelantan, Malaysia, with 6-months follow-up. A total of 116 participants were randomised to either the interventional group (n = 58, who received free Stroke Riskometer app and stroke informational leaflets) or the control group (n = 58, receive standard management). Results: The mean age of participants was 31.97 (SD 9.89). There were no significant differences in the baseline characteristics except for the household income (p-value = 0.023) and the body mass index (BMI) (p-value = 0.038). The interventional group showed significant improvement in the stroke risk awareness level within 3-weeks of study duration (64.4% vs 72.5%; 95% CI, 4.45 to 13.05). Over the 6-weeks study period, the mean stroke risk probability of the interventional group has been significantly lower than that of the control group (1.62% vs 1.95%; 95% CI, 0.119 to 0.888). Conclusion: The preliminary study suggests that the Stroke Riskometer app resulted in more favourable impact on both the stroke risk awareness level as well as the stroke risk probability. If implemented on a larger scale - as a primary preventive modality - in Malaysia, the proposed intervention can potentially benefit the control and prevention of stroke and other similar non-communicable diseases.