Mobility Hypertension Management - Effect of Telemonitoring on Hypertension Management
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure (measured in clinic)
研究概览
简要总结
The present prospective study aims to assess the efficacy of using the telehealth solution "Hypertension Monitor" in patients with hypertension by comparison to the standard care.
详细描述
Although, meta-analysis confirms that BP telemonitoring may represent a useful tool to improve hypertension management, the strength of the provided evidence is limited. Therefore, future well-designed, large-sample, prospective, controlled trials are mandatory to understand the benefit of BP telemonitoring.
Recently, a specific telehealth solution for hypertension management has been developed in France (Hypertension Monitor - e-CoreLab®).
The present prospective study aims to assess the efficacy of using the telehealth solution "Hypertension Monitor" in patients with hypertension by comparison to the standard care.
The primary objective: To evaluate whether a home telehealth system can improve BP control and other risk factors in hypertensive individuals, as compared to the standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
the Data analysis will be performed by an independent team with masking the patients groups
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
- •Men or women
- •Age between 18 and 80 years
- •Patients with essential moderate Hypertension
- •untreated or not adequately treated (need for treatment changes)
- •Given written informed consent
排除标准
- •Severe Hypertension (>180/110 mmHg)
- •Difficulties to perform home blood pressure measurements
- •Patients with arm circumference > 42 cm
- •Night shift workers
- •Body mass index > 35 kg/m²
- •Atrial fibrillation and/or another arrhythmia
- •Pregnancy
- •Cardiovascular events (stroke, Myocardial infarction) in the last 6 months
- •Severe Sleep Apnea Syndrome
结局指标
主要结局
Systolic Blood Pressure (measured in clinic)
时间窗: Primary objective after 3 month
Systolic blood pressure will be measured in clinic according to the guidelines of the European Society of Hypertension (ESH).
次要结局
- Timing to reach the blood pressure target(Evaluation performed at Month1 and Month 3)