Telemedical Algorithm-Supported Care for Hypertension

NCT06722625 | Recruiting

• 1 other identifier: 2/XXI/2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Hypertension; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Assessment of blood pressure values in 24-hour monitoring, home measurements, and office measurements

  Baseline up to approximately six-months of observation

• Assessment of the number of the medical visits

  After completing the presumed six-month follow-up of the last participant

• Assessment of the maintaining blood pressure control

  After completing the presumed six-month follow-up of the last participant

• Assessment of the cost of visits

  After completing the presumed six-month follow-up of the last participant

Study Arms (2)

Control group

NO INTERVENTION

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

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

Interventions

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

Receiving remote care facilitated by a specialized informatic system to support the physician

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences

Poznan, 60-848, Poland

RECRUITING

Related Publications (1)

• Lipski D, Lewandowska K, Zurek S, Wisniewicz M, Pirog P, Tykarski A, Uruski P. Telemedical care system for the treatment of arterial hypertension using recommendation algorithms to support diagnostic and therapeutic decisions-study protocol for a single-center, randomized, controlled, open-label SOT-ART-HT trial. Trials. 2025 Sep 1;26(1):330. doi: 10.1186/s13063-025-09044-w.

  PMID: 40890870 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Central Study Contacts

Paweł Uruski, MD PhD

CONTACT

(+48) 618546274; puruski@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)