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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Arterial Hypertension
• Intervention / Treatment: Other: Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paweł Uruski, MD PhD; Phone Number: (+48) 618546274; Email: puruski@ump.edu.pl

Study Locations

• Poland
  • Poznań, Poland, 60-848
    • Recruiting
    • Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences
    • Contact: Paweł Uruski, MD PhD; Phone Number: (+48)618546274; Email: puruski@ump.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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.
Experimental: Study group; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment 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	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	After 6 months of participating

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	After completing the presumed six-month follow-up of the last participant

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Hypertension; Cardiovascular Diseases
• Other Study ID Numbers: 2/XXI/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No