PS-C03-9: A COMPARATIVE STUDY OF SELF-VITAL MEASUREMENTS AND TELEMEDICINE IN THE TREATMENT OF HYPERTENSION: RATIONALE AND PROTOCOL

Abstract

Background: There has been a series of reports on the effectiveness of ICT-based telemedicine in the treatment of hypertension. However, sufficient evidence has not been obtained in Japan. In this study, we will clarify how push-type communication through the combination of vital data measurements including home blood pressure (HBP) obtained by IoT devices and online visits (telemedicine) affects blood pressure management. Setting: Multicenter, open-label, randomized, prospective intervention study Methods: This study (Fukushima Medical University Ethics Committee Permission no. 2021–292, now registering in jRCT) is an investigator-initiated 6-month clinical trial, which will recruit 234 patients to be randomized in Aizuwakamatsu area, Fukushima, Japan. During the whole study, HBP, body weight and physical activity data will be collected through the internet using smartphone App (OMRON CONNECT and TELEMEDEASE). This study includes 3 arms; 1: Vital data measurement without any feedback (control), 2: Vital data measurement with telemonitoring and feedback from health care professionals such as registered nurse, 3: In addition to telemonitoring and feedback, patients can engage in consulting physicians through telemedicine and receive prescription via mail when needed. Eligible patients are asymptomatic patients with hypertension who are aged 40–75 years old and can measure HBP and use smartphone App. The primary endpoint is percentage of patients achieving antihypertensive goal (mean morning and night systolic HBP < 125 mmHg). Examples of secondary endpoints include medical economics and safety of telemedicine for treatment of hypertension. Anticipated Medical Contributions: The expected outcome is that application of telemedicine on self-measurement of vital data including HBP will be superior to vital data monitoring alone in the treatment of hypertension to improve cardiovascular outcome.