M.H.M. Study

Mobility Hypertension Management Study - (M.H.M. Study)

Main Sponsor
Foundation-Medical Research Institutes -
FMRI®. Switzerland
Co-Sponsors
International Society of Vascular Health - ISVH®. France
e-CoreLab®. France

ORGANIZATION OF THE STUDY

PARTICIPATING COUNTRIES & CENTERS
COUNTRIESCENTERSCOUNTRIESCENTERS
  • ARMENIA
2
  • THE NETHERLANDS
1
  • BELGIUM
1
  • ROMANIA
1
  • BULGARIA
1
  • RUSSIA
2
  • CROATIA
1
  • SERBIA
1
  • FRANCE
2
  • SPAIN
2
  • ITALY
1
  • SWEDEN
1
  • LATVIA
1
  • SWITZERLAND
1
  • POLAND
2
  • UKRAINE
2
  • PORTUGAL
2

BACKGROUND

Meta-analysis showed that BP telemonitoring improves hypertension control and associated healthcare outcomes. Although, meta-analysis confirms that BP telemonitoring may represent a useful tool to improve hypertension management, the strength of the provided evidence is limited by the high heterogeneity among most of the randomized studies. Recently, it has been highlighted that considering the bias evident of several studies, better reporting of health-related apps interventions is required. Therefore, future well-designed, large-sample, prospective, controlled trials are mandatory to understand the benefit of BP telemonitoring.
Several BP telehealth systems are available on the market, they are characterized by different features. 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.

STUDY OBJECTIVES

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.
Secondary Objectives: Assessment of the compliance to treatment; Timing of reaching the target values (control); Satisfaction of feasibility of Telemedicine.
The primary and secondary objectives will be assessed at W24 and W36 (if available).

STUDY DESIGN AND PROCEDURES

General Study Design Groupe A: Standard Care
Participants will receive standard care per the physician practice. Use of home blood pressure monitoring (HBPM) is allowed.
Groupe B: Standard Care + Hypertension Monitor Solution
Participants will receive standard care with the Hypertension Monitor solution including connected electronic device for HBPM.

CALENDAR

Setup & Implementation: Q4 2017 - End of the study: Q4 2018.