Telemedical System Using Algorithms to Support Doctors in Treating Arterial Hypertension
A Study Comparing Remote and Standard Care for Adults 18 to 80 with High Blood Pressure
Led by Poznan University of Medical Sciences · Updated on 2024-12-09
200
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Hypertension is a widespread health issue affecting many people worldwide, including around 9 million in Poland. This research aims to evaluate a blood pressure monitoring system that includes an algorithm to assist doctors in managing patients with arterial hypertension. The study compares two care methods to understand if the telemedical system provides better support for decision-making in treating hypertension.
The trial is a randomized, open-label study involving 200 participants aged 18 to 80 with confirmed arterial hypertension and uncontrolled blood pressure at screening. Participants are divided into two groups one receiving standard care through regular clinic visits, initially monthly and then every three months after blood pressure control the other receiving remote care supported by a tele-informatic system with an algorithm that suggests diagnostic and treatment actions to doctors, though final decisions remain with the physician.
Participants will be followed for approximately six months, during which researchers will assess blood pressure control through office, home, and 24-hour monitoring. They will also evaluate the number and cost of medical visits and how well blood pressure control is maintained. The study includes regular assessments to monitor outcomes and is expected to complete after 2026, with safety and progress overseen by relevant committees.
CONDITIONS
Brief Title
Telemedical Algorithm-Supported Care for Hypertension
Research Team
P
Paweł Uruski, MD PhD
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Voluntarily signing an informed consent to participate in the study
Age between 18 and 80 years
Diagnosis of hypertension according to the Polish Society of Hypertension criteria from 2019, either already treated or newly diagnosed
Blood pressure exceeding 140/90 mmHg in office measurements (during the screening visit)
You will not qualify if you...
Suspicion or diagnosis of secondary hypertension
Pregnant women, breastfeeding women, or those planning pregnancy during the study period
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 6 months
Participants receive either standard hypertension care involving regular clinic visits or remote care supported by a telemedical algorithm to assist their doctor’s decisions.
Regular visits following the Polish Society of Hypertension guidelines: initially once a month, then once every 3 months after blood pressure control is achieved
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
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.
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