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Mobility Hypertension Management Study (MHM)

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
telemonitoring
Sponsored by
International Society for Vascular Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring Hypertension, Telemonitoring, Digital Health

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Roland AsmarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Standard Care

Telemonitoring group

Arm Description

This group is the usual standard treatment group

This group will followed up with telemonitoring

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Timing to reach the blood pressure target
how long we need to reach the Blood pressure normalization

Full Information

First Posted
February 2, 2018
Last Updated
August 7, 2018
Sponsor
International Society for Vascular Health
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1. Study Identification

Unique Protocol Identification Number
NCT03454516
Brief Title
Mobility Hypertension Management Study
Acronym
MHM
Official Title
Mobility Hypertension Management - Effect of Telemonitoring on Hypertension Management
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 3, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Society for Vascular Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Telemonitoring, Digital Health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two randomized parallel groups. one group with standard care and one group with telemonitoring of blood pressure and hypertension.
Masking
Outcomes Assessor
Masking Description
the Data analysis will be performed by an independent team with masking the patients groups
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
This group is the usual standard treatment group
Arm Title
Telemonitoring group
Arm Type
Other
Arm Description
This group will followed up with telemonitoring
Intervention Type
Other
Intervention Name(s)
telemonitoring
Intervention Description
the follow-up of the patient will be performed with Telemonitoring
Primary Outcome Measure Information:
Title
Systolic Blood Pressure (measured in clinic)
Description
Systolic blood pressure will be measured in clinic according to the guidelines of the European Society of Hypertension (ESH).
Time Frame
Primary objective after 3 month
Secondary Outcome Measure Information:
Title
Timing to reach the blood pressure target
Description
how long we need to reach the Blood pressure normalization
Time Frame
Evaluation performed at Month1 and Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ROLAND ASMAR, MD
Phone
+33640142239
Email
ra@cmcv.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROLAND ASMAR, MD
Organizational Affiliation
Foundation-Medical research Institutes
Official's Role
Study Chair
Facility Information:
Facility Name
Roland Asmar
City
Paris
ZIP/Postal Code
75016
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROLAND ASMAR
Phone
640142239
Email
ra@cmcv.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://e-corelab.com/

Learn more about this trial

Mobility Hypertension Management Study

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