Hypertension
Conditions
Keywords
Hypertension, Telemonitoring, Digital 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.
Interventions
OTHERtelemonitoring
the follow-up of the patient will be performed with Telemonitoring
Sponsors
International Society for Vascular Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
the Data analysis will be performed by an independent team with masking the patients groups
Intervention model description
two randomized parallel groups. one group with standard care and one group with telemonitoring of blood pressure and hypertension.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Timing to reach the blood pressure target | Evaluation performed at Month1 and Month 3 | how long we need to reach the Blood pressure normalization |
Countries
France
Contacts
Primary ContactROLAND ASMAR, MD
Outcome results
None listed