Prospective evaluation of digital therapeutic intervention on blood pressure control in Indian patients with uncontrolled primary hypertension
Authors: Patil S , Kalashetti S , Kokane H , Somalaram V , Kaur A , Gupta V 
Published: January 2023

Abstract

Funding Acknowledgements
Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Terrals Technologies Private Limited

Background
Digital therapeutics (DTx) has emerged as a new approach in recent years making use of connected devices, smartphone software and electronic communication tools to help manage chronic cardiovascular diseases such as hypertension. Considering its nascent stage, many questions still remain with respect to its applicability, effectiveness and limitations.

Purpose
Assess the effectiveness of digital therapeutic intervention in controlling blood pressure in Indian patients with primary hypertension

Methods
We conducted a prospective, 12 week, single arm, interventional study, including 125 subjects at multiple sites in India. Subjects with uncontrolled primary hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic) in the age group of 30-65 years who were under routine antihypertensive treatment were enrolled. They were provided supplementary DTx intervention comprising of smartphone application based personalized management of diet, exercise, self monitoring and health education by nutritionists and health coaches. Efficacy endpoints such as blood pressure (BP), body mass index (BMI), lipids, etc. were measured before and after the intervention.

Results
A total of 122 subjects who completed the trial had mean age of 47.44 ± 9.43 years, comprising 58 (48%) male and 64 (52%) female patients and mean BMI of 27.21 ±4.7 kg/m². Post-intervention change in mean systolic BP (SBP) was -25.61 mmHg (95% CI 22.55 - 28.66, 154.98 mmHg vs 129.37 mmHg, P&lt;.001). The post-intervention change in mean diastolic BP (DBP) was -18.62 mmHg (95% CI 16.29 - 20.96, 100.04 mmHg vs 81.42 mmHg, P&lt;.001). Patients with stage 1 hypertension (69.6%) achieved mean systolic reduction of 20.87 ± 13.9 mmHg, (148.54 mmHg vs 127.67 mmHg, P&lt;.001). The patients with stage 2 (27.04%) and stage 3 (3.27%) hypertension achieved a higher mean SBP reduction of 34.67 ± 15.19 mmHg (167.24 mmHg vs 132.58 mmHg, P&lt;.001) and 51.5 ± 40.45 mmHg (190.75 mmHg vs 139.25 mmHg, P=.084), respectively. Male and female patients showed almost similar reduction in systolic BP of 25.47 ± 14.72 and 25.73 ± 19.39 mmHg, respectively. Also, the subjects with other chronic comorbidities (23.9%) achieved a mean systolic BP reduction of 29.51 ± 15.25 mmHg.
A total of 79.51% (n=97) patients achieved the SBP &lt;140 mmHg, while 59.84% (n=73) patients achieved SBP &lt;130 mmHg. Combining both the systolic and diastolic targets together, 65.57% (n=80) patients achieved the target of &lt;140/90 mmHg, while ESC/ESH 2018 recommended BP target of &lt;130/80 mmHg was achieved by 31.15% (n=38) patients.

Conclusion
The implementation of Digital therapeutic application integrated with primary healthcare resulted in significant reduction in blood pressure in participants with uncontrolled hypertension. Greater improvement was observed in participants with higher baseline blood pressure.