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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
Receiving remote care facilitated by a specialized informatic system to support the physician
Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences
Poznan, Poland
RECRUITINGAssessment of Achieving Arterial Blood Pressure Control
Time from study initiation to the day of achieving arterial blood pressure control, defined as a 7-day mean of home blood pressure measurements below 135/85 mmHg
Time frame: After completing the presumed six-month follow-up of the last participant
Assessment of Achieving Arterial Blood Pressure control at 6 months
The time from study initiation to 6 months of participation, achieving arterial blood pressure control, defined as a 7-day average of home blood pressure measurements below 135/85 mmHg
Time frame: After 6 months of participating
Assessment of blood pressure values in 24-hour monitoring, home measurements, and office measurements
Analysis of Blood Pressure Values: 24-Hour Monitoring, Home Measurements, and Office Measurements
Time frame: Baseline up to approximately six-months of observation
Assessment of the number of the medical visits
The number of medical visits from study initiation to completion
Time frame: After completing the presumed six-month follow-up of the last participant
Assessment of the maintaining blood pressure control
Total time maintaining blood pressure control, defined as the number of days with a 7-day mean of home measurements below 135/85 mmHg
Time frame: After completing the presumed six-month follow-up of the last participant
Assessment of the cost of visits
Cost of visits incurred by the medical institution and the patient
Time frame: After completing the presumed six-month follow-up of the last participant
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