Evaluation of cardiovascular risk scores after implementation of digital therapeutic intervention in patients with uncontrolled primary hypertension

Abstract

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Terrals Technologies Private Limited Background Cardiovascular risk scores serve as a useful tool to reinforce the importance of lifestyle modifications and treatment compliance. Yet, there remains a gap between advice by the physician and its implementation by the patient. Digital therapeutics (DTx) as a technology based approach can help bridge this gap. In this context, knowing the quantum of change in disease outcomes and long term cardiovascular risk after DTx implementation can be helpful in persuading the patients for lifestyle interventions. Purpose To evaluate the change in cardiovascular risk scores in hypertensive patients after a digital therapeutic intervention. Method We conducted a prospective, single arm, 12-week intervention trial at two primary care sites in India. A total of 125 subjects within the age group of 30-65 years with primary hypertension (≥ 140/90 mmHg) were enrolled. They were provided DTx intervention which consisted of modification in diet, physical activities, self-monitoring and health education superimposed on behavior science theories. Atherosclerotic Cardiovascular Disease (ASCVD) risk scores from Pooled Cohort Equation were calculated for all subjects before & after the DTx intervention and the change in score was assessed. Results We received the data of 116 patients having a mean age of 47.66 ± 9.47 years and mean BMI of 27.20 ± 4.77 Kg/m². After DTx intervention, the change in mean systolic blood pressure, among other ASCVD equation parameters, was -26.38 mmHg (154.77 vs 128.39 mmHg, P<0.001). The corresponding post-intervention 10-year mean ASCVD risk score for the sample population decreased by 4.74% (11.86% vs 7.12%, P<0.001). The 10-year mean relative risk of ASCVD decreased by 39.95 %. Similarly ASCVD lifetime risk score decreased by 3.04% (49.54% vs 46.50%, P<0.001), amounting to mean relative risk reduction of 6%. Female subjects (n=60) showed higher 10-year mean ASCVD risk reduction of 5.70% (11.70% vs 6.00%, P<0.001), compared to male subjects (n=56) who showed 10-year mean ASCVD risk reduction of 3.76% (12.06% vs 8.30%, P<0.001). This amounted to a relative risk reduction of 48.69% and 30.71% for female & male subjects, respectively. Patients with stage 1 hypertension (n=82) showed a reduction in 10-year mean ASCVD risk of 2.86% (9.90% vs 7.04%, P<0.001). Patients with stage 2 (n=30) & stage 3 hypertension (n=4) achieved higher 10-year mean ASCVD risk reduction of 8.67% (16.07% vs 7.40%, P<0.001) & 13.6% (20.88% vs 7.20%, P=.006). Conclusion Digital therapeutics enabled intervention has caused a significant decrease in 10-year & lifetime ASCVD risks which can eventually lead to a decrease in cardiovascular complications, morbidity and mortality. Therefore, such intervention programs should be further explored and studied.