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A parallel-arm randomised control trial to study the effects of risk communication methods for prevention of
Kritika Singhal1, Pankaj Prasad1, Deb Kumar Pal2
1Department of Community and Family Medicine, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India.
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.
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