Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2018-06-03
2019-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Standard Care
This group is the usual standard treatment group
No interventions assigned to this group
Telemonitoring group
This group will followed up with telemonitoring
telemonitoring
the follow-up of the patient will be performed with Telemonitoring
Interventions
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telemonitoring
the follow-up of the patient will be performed with Telemonitoring
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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International Society for Vascular Health
OTHER
Responsible Party
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Principal Investigators
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ROLAND ASMAR, MD
Role: STUDY_CHAIR
Foundation-Medical research Institutes
Locations
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Roland Asmar
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FMRIMHM2018
Identifier Type: -
Identifier Source: org_study_id
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