A parallel-arm randomised control trial to study the effects of risk communication methods for prevention of cardiovascular diseases: EFFRICO trial.

ABSTRACT

Introduction: Cardiovascular diseases (CVDs) have many risk factors; few can be modified through health education. Traditional patient counselling methods fail to impact health behaviours to prevent or reduce the risk of CVDs. Objectives: This study was conducted to estimate the effect of various risk communication methods on CVD risk reduction and medication adherence. Design: An open-label superiority randomised control trial was conducted where 159 patients were randomised into three groups Communication of 10-year Framingham CVD risk score, heart age, and routine care. Follow-up was done 3 months after recruitment. The primary outcome was a difference in excess 10-year Framingham CVD risk score in the end-line compared to baseline. The status of modifiable behavioural risk factors at baseline was expressed as 'yes' and 'no', and follow-up was defined as 'action', 'positive maintenance', 'negative maintenance', and 'defaulter'. The trial was registered with the Clinical Trials Registry India (CTRI NO. CTRI/2020/10/028614). Setting: The study setting was screening outpatient department (OPD), General Medicine OPD, and Cardiology OPD of a tertiary care hospital in Central India. Participants: Participants aged >30 years, residing in Bhopal for more than 6 months, diagnosed with hypertension or diabetes mellitus or both, and having any of the four CVD behavioural risk factors tobacco use, alcohol use, physical inactivity, or unhealthy diet. Results: Median excess 10-year Framingham CVD risk scores were 0.945% (CI 1.275-4.297), -0.850% (-3.932-2.075), and -1.300% (-5.100-0.900) (10-year Framingham CVD risk score vs Heart age vs Routine care) and 0.000% (-3.125-5.925), -1.600% (-3.760-1.475), and -1.400% (-6.600-5.900) before and after intervention, respectively (P > 0.05). Positive maintenance was higher in both intervention groups concerning all modifiable behaviours, with a higher proportion reported in the 10-year Framingham risk score. The action phase was reported higher in intervention groups for medication adherence, addiction, and dietary changes. Conclusion: Systematic risk communication methods reduced the probability of contracting CVD in the future, though this finding was statistically insignificant.