Clinical trial NCT06722625: Telemedical Algorithm-Supported Care for Hypertension
Official title: Telemedical Care System for the Treatment of Arterial Hypertension Using Recommendation Algorithms to Support Diagnostic and Therapeutic Decisions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arterial Hypertension
Cardiovascular Diseases
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Achieving Arterial Blood Pressure Control
timeFrame: After completing the presumed six-month follow-up of the last participant
measure: Assessment of Achieving Arterial Blood Pressure control at 6 months
timeFrame: After 6 months of participating
Secondary outcomes:
measure: Assessment of blood pressure values in 24-hour monitoring, home measurements, and office measurements
timeFrame: Baseline up to approximately six-months of observation
measure: Assessment of the number of the medical visits
timeFrame: After completing the presumed six-month follow-up of the last participant
measure: Assessment of the maintaining blood pressure control
timeFrame: After completing the presumed six-month follow-up of the last participant
measure: Assessment of the cost of visits
timeFrame: After completing the presumed six-month follow-up of the last participant
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences
Study officials:
References: