Telemedical Algorithm-Supported Care for Hypertension (SOT-ART-HT)

Poznan University of Medical Sciences (PUMS)

Status: Enrolling

Conditions: Arterial Hypertension; Cardiovascular Diseases

Treatments: Other: Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process

Study type: Interventional

Funder types: Other

Identifiers

NCT06722625

2/XXI/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntarily signing an informed consent to participate in the study.
2. Age between 18 and 80 years.
3. Diagnosis of hypertension according to the Polish Society of Hypertension criteria from 2019, either already treated or newly diagnosed.
4. Blood pressure exceeding 140/90 mmHg in office measurements (during the screening visit).

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Control group

No Intervention group

Description:

Standard care involving regular visits to a hypertension clinic. Patients in the control group will receive standard care. They will have appointments according to the guidelines of the Polish Society of Hypertension -initially once a month and, after achieving control (i.e., blood pressure in office measurement \< 140/90 mmHg), once every 3 months.

Study group

Experimental group

Description:

In the intervention group, a care model using a system implementing an algorithm that supports therapeutic and diagnostic decisions made by the doctor in the care of patients with AH will be applied. The algorithm identifies patients who have or have not achieved therapeutic goals and suggests actions for specific patients, but the final therapeutic and diagnostic decisions are always made by the doctor. It is emphasized that the treating physician is not bound by the algorithm's recommendations.

Treatment:

Other: Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process