Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06722625

Telemedical Care System for Arterial Hypertension Using Algorithms to Support Doctor Decisions

Led by Poznan University of Medical Sciences · Updated on 2024-12-09

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • Suspicion or diagnosis of secondary hypertension
  • Pregnant women, breastfeeding women, or those planning pregnancy during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 1 location

1

Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences

Poznan, Poland, 60-848

Actively Recruiting

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Research Team

P

Paweł Uruski, MD PhD

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.

Dawid Lipski, Katarzyna Lewandowska, Sebastian Żurek...

https://pubmed.ncbi.nlm.nih.gov/40890870