NCT06722625

Telemedical Algorithm-Supported Care for Hypertension

Telemedical Care System for the Treatment of Arterial Hypertension Using Recommendation Algorithms to Support Diagnostic and Therapeutic Decisions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Poznan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Hypertension is a major global health issue, affecting around 9 million people in Poland. While some studies indicate that telemonitoring benefits patients with hypertension, there is a lack of research evaluating tools that assist doctors in managing these patients. The objective of this study is to assess a blood pressure monitoring system with an integrated algorithm that aids doctors in the decision-making process.

Detailed description

The SOT-ART-HT study is a single-center, randomized, open-label trial aimed at comparing two strategies for managing arterial hypertension. Patients in the control group will receive standard care, which includes regular visits to a hypertension clinic, while those in the intervention group will receive remote care through a specialized tele-informatic system designed to assist the physician. The trial will involve 200 participants, aged 18-80, with confirmed arterial hypertension and uncontrolled office blood pressure at the screening visit. Both primary and secondary outcomes will be evaluated, with the study expected to be completed after 2026. However, early termination could occur if required by regulatory bodies, an Ethics Committee, or the Scientific Research Committee.

Conditions

• Arterial Hypertension
• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process	Receiving remote care facilitated by a specialized informatic system to support the physician

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-12-09
• Last updated: 2024-12-09

Locations

1 site across 1 country: Poland