Telemedical Algorithm-Supported Care for Hypertension
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process.
- Кому может быть актуально
- Состояния в реестре: Arterial Hypertension, Cardiovascular Diseases. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Польша
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Telemedical Care System for the Treatment of Arterial Hypertension Using Recommendation Algorithms to Support Diagnostic and Therapeutic Decisions
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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
Первичные конечные точки
- Assessment of Achieving Arterial Blood Pressure Control [Срок оценки: After completing the presumed six-month follow-up of the last participant]
- Assessment of Achieving Arterial Blood Pressure control at 6 months [Срок оценки: After 6 months of participating]
Вторичные конечные точки (4)
- Assessment of blood pressure values in 24-hour monitoring, home measurements, and office measurements [Срок оценки: Baseline up to approximately six-months of observation]
- Assessment of the number of the medical visits [Срок оценки: After completing the presumed six-month follow-up of the last participant]
- Assessment of the maintaining blood pressure control [Срок оценки: After completing the presumed six-month follow-up of the last participant]
- Assessment of the cost of visits [Срок оценки: After completing the presumed six-month follow-up of the last participant]
Критерии участия
Критерии включения
- 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).
Критерии исключения
- Suspicion or diagnosis of secondary hypertension.
- Pregnant women, breastfeeding women, or those planning pregnancy during the study period.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Польша · 1 центр
- Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medic — Poznan
Публикации
- 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
Идентификаторы
NCT: NCT06722625 · 2/XXI/2023