Mobility Hypertension Management Study
- Conditions
- Hypertension
- Interventions
- Other: telemonitoring
- Registration Number
- NCT03454516
- Lead Sponsor
- International Society for Vascular Health
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemonitoring group telemonitoring This group will followed up with telemonitoring
- Primary Outcome Measures
Name Time Method Systolic Blood Pressure (measured in clinic) Primary objective after 3 month Systolic blood pressure will be measured in clinic according to the guidelines of the European Society of Hypertension (ESH).
- Secondary Outcome Measures
Name Time Method Timing to reach the blood pressure target Evaluation performed at Month1 and Month 3 how long we need to reach the Blood pressure normalization
Trial Locations
- Locations (1)
Roland Asmar
🇫🇷Paris, France