Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Protocol for a Randomized Controlled Prospective Trial (HOROSCOPE Study).

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 control.

Objective: The aim of our study will be to evaluate the effects of telemonitoring with antihypertensive treatment titration on blood pressure control in Tunisian patients with hypertension.

Methods: Our trial 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 enrollment if they are aged over 35 years, are newly diagnosed with hypertension, or are known to be poorly controlled on antihypertensive therapy. Participants will be randomly assigned in a 1:1 ratio to the telemonitoring arm or usual care arm. The telemonitoring arm will involve a weekly telephone call for the collection of the home blood pressure measurements, therapeutic education, and treatment compliance assessment as well as a monthly call for treatment titration and a side effect check. Randomization will be done via the use of an interactive web responsive system, and patients will be stratified by investigation center. Neither participants nor investigators will be masked to the group assignments. The primary outcome will be the change in mean 24-hour systolic blood pressure from baseline to the 6-month follow-up in the 2 groups. All randomized patients who 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 by the end of 2021 and plan to disseminate the results subsequently.

Conclusions: The HOROSCOPE (Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Randomized Controlled Prospective Trial) study will provide important new evidence that could shed some light on the feasibility and impact of telemonitoring and self-monitoring in a Tunisian population of patients with hypertension who consult primary care physicians.

Trial Registration: ClinicalTrials.gov NCT04607239; https://clinicaltrials.gov/ct2/show/NCT04607239.

International Registered Report Identifier (irrid): DERR1-10.2196/26184.