Telemedical care system for the treatment of arterial hypertension using recommendation algorithms to support diagnostic and therapeutic decisions-study protocol for a single-center, randomized, controlled, open-label SOT-ART-HT trial.
Dawid Lipski, Katarzyna Lewandowska, Sebastian Żurek, Mateusz Wiśniewicz, Przemysław Piróg, Andrzej Tykarski, Paweł Uruski
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引用次数: 0
Abstract
Background: Arterial hypertension is a global issue and achieving the blood pressure control is a challenge. It has been suggested that telemonitoring benefits these patients but there is a lack of research evaluating tools to assist doctors in caring for patients with arterial hypertension. Herein, we detail a protocol for a single-center, randomized, open-label study with a control group to develop a blood pressure monitoring system with a built-in algorithm supporting the physician's decisions.
Methods: Two hundred patients aged 18-80 with a confirmed diagnosis of arterial hypertension and uncontrolled blood pressure during the screening visit will be recruited for the study. Patients with suspected or diagnosed secondary hypertension and pregnant/breast-feeding women will be excluded. In the initial study phase, a system will be developed for remote blood pressure monitoring, recording measurements, and detecting situations requiring medical assessment and potential intervention to identify patients needing urgent medical attention through innovative analysis of blood pressure measurements and co-morbidity data. Next, telemetric and algorithm-supported care will be compared to the standard care of hypertensive patients. Patients will be randomized 1:1 to each group and be observed for 6 months. Pharmacotherapy will be modified, office blood pressure, home blood pressure, and 24-h ambulatory blood pressure will be measured, and the presence of organ complications will be checked during visits.
Discussion: The primary endpoints include the time from study enrollment to the day of achieving blood pressure control and achieving blood pressure control within 6 months. Secondary endpoints involve some other parameters of blood pressure control and the costs analyses. The results are expected after 2026 and are anticipated to increase patient-to-physician ratios, allow the remote identification of urgent cases, reduce outpatient appointments, and achieve faster blood pressure control through telemetric observation with the algorithm compared to standard care.
Trial registration: Clinical Trials NCT06722625, December 6, 2024.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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