Self-Monitoring of Blood Pressure and Feed-back Using APP in TReatment of UnconTrolled Hypertension (SMART-BP): A Randomized Clinical Trial

Abstract

Background and objectives: Self-monitoring of blood pressure (SMBP) is a reliable method used to assess BP accurately. However, patients do not often know how to respond to the measured BP value. We developed a mobile application-based feed-back algorithm (SMBP-App) for tailored recommendations. In this study, we aim to evaluate whether SMBP-App is superior to SMBP alone in terms of BP reduction and drug adherence improvement in patients with hypertension.

Methods: Self-Monitoring of blood pressure and Feed-back using APP in TReatment of UnconTrolled Hypertension (SMART-BP) is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App compared with SMBP alone. Patients with uncomplicated essential hypertension will be randomly assigned to the SMBP-App (90 patients) and SMBP alone (90 patients) groups. In the SMBP group, the patients will perform home BP measurement and receive the standard care, whereas in the SMBP-App group, the patients will receive additional recommendations from the application in response to the obtained BP value. Follow-up visits will be scheduled at 12 and 24 weeks after randomization. The primary endpoint of the study is the mean home systolic BP. The secondary endpoints include the drug adherence, the home diastolic BP, home and office BP.

Conclusions: SMART-BP is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App. If we can confirm its efficacy, SMBP-App may be scaled-up to improve the treatment of hypertension.

Trial registration: ClinicalTrials.gov Identifier: NCT04470284.

Keywords: Blood pressure; Hypertension; Medication adherence; Mobile health.