Mobility Hypertension Management Study (MHM)

International Society for Vascular Health

Status: Unknown

Conditions: Hypertension

Treatments: Other: telemonitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03454516

FMRIMHM2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Standard Care

No Intervention group

Description:

This group is the usual standard treatment group

Telemonitoring group

Other group

Description:

This group will followed up with telemonitoring

Treatment:

Other: telemonitoring