SIMPLIFIED REGIMEN FOR THE MANAGEMENT OF HYPERTENSION WITH TELEMEDICINE AND BLOOD PRESSURE SELF-MONITORING (SIMPLE): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL

Abstract

Objective: Telemedicine and blood pressure (BP) self-monitoring conduces to management of hypertension. Recent hypertension guidelines highly recommended single-pill-combination (SPC) for the initial treatment of essential hypertension. Based on this fact, an SPC-based telemedicine titration regimen with BP self-monitoring could be a better way in managing hypertension. This trial aims to elucidate whether telemedicine combined with BP self-monitoring is superior to self-monitoring alone during hypertension management. Design and method: This study will be a multi-centered, open-labelled, randomized controlled trial. A minimum sample of 358 hypertensive patients with uncontrolled BP from four centers will be included. The intervention group will include BP self-monitoring and tele-monitoring plus a free SPC-based telemedicine titration therapy for 6 months, they will be recommended to take BP measurements at least once every seven days, in the meantime, researchers will call to give a consultation on lifestyle or titration advice once a fortnight. The control group will be required to self-monitor BP at the same time interval as intervention group, without any therapy change. Primary outcome of the trial will be the difference in SBP at 6-month follow-up between intervention and control group, adjusted for baseline variables. Secondary outcomes such as BP control rate, major adverse cardiovascular events, medication adherence, quality of life will be investigated. Results: Ongoing study, no further results to share at this time. Conclusions: Ongoing study, no further results to share at this time.