Effect of a digital blood pressure coach on hypertension management in primary care practices—a pragmatic, randomised controlled trial
Abstract
Importance Smartphone medical applications (apps) may improve blood pressure (BP) control in the primary care setting in patients with hypertension. However, real-world evidence from primary care is largely lacking. Objective To analyse, in primary care practices in Germany, the effect of a smartphone app on systolic BP compared to standard of care. Design A pragmatic, non-blinded randomized controlled trial with patients with a diagnosis of hypertension was conducted across 23 general practices in Germany, with a follow-up period of 3 months. Recruitment occurred from January 2022 to May 2023. Intervention The intervention group received access to the Manoa app, a smartphone coach integrating guideline-compliant home BP monitoring and lifestyle-coaching. All study participants received standard treatment for arterial hypertension at the discretion of the treating physician. Main Outcomes The primary outcome was office systolic BP (oSBP) after 90–150 days in participants with uncontrolled hypertension (oSBP ≥140 mmHg). Secondary outcomes included changes in systolic and diastolic BP, BP control and adherence to home blood pressure monitoring. Results A total of 606 participants from 23 general practices were randomized, after data clearance and review, 249 participants were assigned to the control group and 259 to the intervention group for analysis. The mean age (SD) of participants in the intervention group was 55.9 (12.9) years. At baseline, participants with uncontrolled…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 606 participants or records.
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