Objective: Self-monitoring of blood pressure (SMBP) is a reliable method used to assess blood pressure (BP) accurately. However, patients do not often know how to respond to the measured BP value. We developed a mobile application-based feedback for tailored recommendations and aimed to evaluate whether this feedback is superior to SMBP alone in terms of BP reduction and drug compliance improvement in patients with hypertension. Design and method: Self-Monitoring of and Feed-back using APP in TReatment of UnconTrolled Blood Pressure (SMART-BP) is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App compared with SMBP alone. In the SMBP alone group, the patients performed home BP measurement and receive the standard care, whereas in the SMBP-App group, the patients received additional recommendations from the application using feedback algorithm in response to the obtained BP value. The primary endpoints were mean home BP and adherence of antihypertensive medication. Follow-up visits were scheduled at 12 and 24 weeks after randomization. Results: Among total 173 patients (88 for SBMP-app and 85 for SMBP alone) with full-analysis set, 53% were men, and the mean age was 59.8 years. Baseline characteristics including BP were not significantly different between two groups. At 6 months, mean reduction in home systolic BP was significantly higher in SMBP-App group than SBMP alone group (-20.0±13.5 vs. -14.9±12.9, = 0.012). Also, SMBP-app group showed higher drug adherence value and proportion of adherence over 95% than in SMBP alone group (95.2% vs. 90.4%, P = 0.004; 72/88 vs. 46/85, P = 0.010). Reduction in home systolic BP at 3 months and office systolic BP at 3 months were also higher in SBMP-App, similar with primary end point. Conclusions: SMBP-App is superior to SMBP alone in terms of blood pressure reduction and improved drug adherence in patients with hypertension.
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