JMIR Publications

ABSTRACT

Background:

Despite the availability of effective treatment, the control of hypertension remains insufficient. Telemonitoring in the management of hypertension would be an effective way to improve blood pressure (BP) control.

Objective:

The aim of this study is to evaluate the effects of telemonitoring with anti-hypertensive treatment titration on blood pressure control in Tunisian hypertensive patients.

Methods:

It will be a prospective, rater blinded, randomized, controlled trial carried out with primary care physicians in the Sahel region of Tunisia. Patients will be eligible for enrolment if they are over 35 years of age, newly diagnosed with hypertension, or known to be poorly controlled on antihypertensive therapy. Participants will be randomly assigned in a 1:1 ratio to the telemonitoring or usual care arm. The telemonitoring arm involves of a weekly telephone call for collection of the home BP measurements, therapeutic education, treatment compliance assessment, as well as having a monthly call for treatment titration and side effects check. Randomization will be done by use of interactive web responsive system (IWRS) and will be stratified by investigation centers. Neither participants nor investigators will be masked to groups’ assignment. The primary outcome is the change from baseline in the 2 groups of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up. All randomized patients who will attend the follow-up visit at 6 months and have no missing data for the primary outcome will be included in the analysis.

Results:

Recruitment to the trial started in July 2020. The study was initiated with 17 primary care physicians. We expect the inclusion period to last for approximately 6 months. We expect to complete data collection at the end of 2021 and plan the dissemination of the results subsequently.

Conclusions:

The HOROSCOPE trial will provide important new evidence that could shed some light on the feasibility and impact of telemonitoring along with self-monitoring in a Tunisian hypertensive population consulting in primary care. Clinical Trial: Trial Registration: ClinicalTrials.gov identifier: NCT04607239;