A Smartphone-Guided Digital Health Application for Hypertension: The Randomized Controlled HELP Trial.

Background: Hypertension is a significant risk factor for cardiovascular disease development. Current guidelines recommend a combination of medication and lifestyle modifications, particularly with regard to diet, exercise, blood pressure monitoring, and therapy adherence. To support this, the digital health application "Vantis Bluthochdruck" (Vantis app) was developed.

Methods: A prospective trial in 98 patients with uncontrolled hypertension at seven German centers tested whether the Vantis app lowers systolic blood pressure. Patients were randomized 1:1 to the app or standard care, with investigators blinded to group allocation at baseline. The primary endpoint was systolic blood pressure after 13 weeks, and the secondary endpoints were therapy adherence, diastolic blood pressure, resting heart rate, body mass index, and unplanned medical visits. The study is registered under DRKS00031923.

Results: The intervention group showed a significantly greater reduction in the primary endpoint, systolic blood pressure, than the control group (difference 5.5 mmHg, 95% confidence interval [1.3; 9.8]; p = 0.011). Systolic blood pressure fell from 151.4 mmHg [149.1; 153.8] to 144.3 mmHg [141.2; 147.3] in the control group and from 152.5 mmHg [149.8; 155.2] to 140.1 mmHg [136.7; 143.5] in the intervention group. Patients in the intervention group exhibited higher therapy adherence with no differences in other secondary endpoints. No app-related adverse events were reported.

Conclusion: The study indicates that the tested digital health application lowers systolic blood pressure in hypertensive patients and increases guideline adherence.