Mobility Hypertension Management Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobility Hypertension Management - Effect of Telemonitoring on Hypertension Management

Conditions
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Hypertension

Intervention / Treatment
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* Other: telemonitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two randomized parallel groups. one group with standard care and one group with telemonitoring of blood pressure and hypertension.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>This group is the usual standard treatment group | |
| Other: Telemonitoring group<br>This group will followed up with telemonitoring | Other: telemonitoring<br>* the follow-up of the patient will be performed with Telemonitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure (measured in clinic) | Systolic blood pressure will be measured in clinic according to the guidelines of the European Society of Hypertension (ESH). | Primary objective after 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing to reach the blood pressure target | how long we need to reach the Blood pressure normalization | Evaluation performed at Month1 and Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Telemonitoring, Digital Health