Mobility Hypertension Management Study (MHM)

Mobility Hypertension Management - Effect of Telemonitoring on Hypertension Management

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Other: telemonitoring

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ROLAND ASMAR, MD; Phone Number: +33640142239; Email: ra@cmcv.org

Study Locations

• France
  • Paris, France, 75016
    • Recruiting
    • Roland Asmar
    • Contact: ROLAND ASMAR; Phone Number: 640142239; Email: ra@cmcv.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard Care; This group is the usual standard treatment group
OTHER: Telemonitoring group; This group will followed up with telemonitoring	Other: telemonitoring; the follow-up of the patient will be performed with Telemonitoring

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: International Society for Vascular Health
• Investigators: Study Chair: ROLAND ASMAR, MD, Foundation-Medical Research Institutes

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2018
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): December 30, 2019

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (ACTUAL): March 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Hypertension; Telemonitoring; Digital Health
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: FMRIMHM2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the essential documents and the study results will be shared with all the investigators.
• IPD Sharing Time Frame: Study documents: Q1 2018 Study Results: Q2 2019
• IPD Sharing Access Criteria: the request will be reviewed by the scientific committee. Requestors will be required to sign an access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No