Telemedical Care System for the Treatment of Arterial Hypertension Using Recommendation Algorithms to Support Diagnostic and Therapeutic Decisions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Assessment of Achieving Arterial Blood Pressure Control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Suspicion or diagnosis of secondary hypertension.
- •Pregnant women, breastfeeding women, or those planning pregnancy during the study period.
结局指标
主要结局
Assessment of Achieving Arterial Blood Pressure Control
时间窗: After completing the presumed six-month follow-up of the last participant
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
Assessment of Achieving Arterial Blood Pressure control at 6 months
时间窗: After 6 months of participating
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
次要结局
- 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)