The Impact of Telemonitoring in the Management of Hypertension

Study Overview
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Brief Summary
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Rater blinded, multi-center, prospective, randomized controlled study comparing mean 24 hour systolic blood pressure of eligible hypertensive patients in the TELEMONITORIN group versus the USUAL CARE group, at 6 months after inclusion.

Official Title
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HOme telemonitoRing of Arterial hypertensiOn With antihypertenSive Treatment Titration: a Randomized COntrolled prosPEctive Trial

Conditions
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Health Services Administration, Telemedicine, Hypertension

Intervention / Treatment
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* Procedure: Telemonitoring
* Procedure: Usual Care without Telemonitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Included are patients with: age ≥ 35 years old newly diagnosed hypertention uncontrolled hypertention Exclusion Criteria: Excluded are patients with: orthostatic hypotension chronic renal failure (serum creatinine > 200 micromol / L) acute coronary syndrome coronary revascularization or stroke within the past 3 months known secondary causes of hypertension pregnancy New York Heart Association Class III or IV heart failure or left ventricular ejection fraction < 30% dementia or another cause that prevents the application of remote monitoring

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The interventional group (Telemonitoring) in addition to the usual care group (conventional) will benefit from: a weekly telephone call for collection of home Blood Pressure measurements , therapeutic education & treatment compliance check a monthly call for treatment titration and side effects check
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring<br>In addition to the usual care, this group benefits from a weekly telephone call by the Clinical Research Associate (CRA) for the collection of home blood pressure measurements (which the patient measures twice a day everyday), for therapeutic education, and for treatment compliance assessment. This group will also benefit from a monthly call by the attending physician for treatment titration and side effects check. | Procedure: Telemonitoring<br>* A weekly telephone call by the CRA for the collection of home blood pressure measurements (which the patient measures twice a day everyday), for therapeutic education, and for treatment compliance assessment. A monthly call by the attending physician for treatment titration and side effects check.<br>|
| Other: Conventional<br>This group will benefit form the usual care without any phone calls for therapeutic education, treatment compliance assessment, treatment titration or side effects check. The usual care includes attending the follow up visits after inclusion at Day 90 (D-90) & Day 180 (D-180) for face to face consultation with the attending physician. | Procedure: Usual Care without Telemonitoring<br>* Attending the follow up visits after inclusion at Day 90 (D-90) & Day 180 (D-180) for face to face consultation with the attending physician. Usual care without any phone calls for therapeutic education, treatment compliance assessment, treatment titration or side effects check.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of 24h systolic blood pressure (SBP) | The change from baseline of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up | 0 - 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of 24h diastolic blood pressure (DBP) | The change from baseline of mean 24 hour diastolic blood pressure (DBP) at 6 months of follow-up | 0-180 days | 
| percentage of blood pressure load | The change of blood pressure load's percentages between baseline and 6 months of follow-up | 0-180 days | 
| percentage of Dipping | The change of dipping percentages between baseline and 6 months of follow-up | 0-180 days | 
| Mean of the Short Form survey (SF-12) scores | The change in the mean of SF-12 scores between baseline and 6 months of follow-up | 0-180 days | 
| frequency of cardiovascular complications | Clinical outcomes including hospitalization rate, emergency room admissions related to high blood pressure, adverse effects, or other reasons | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telecare, Telecommunication, Teleconsult, Telemanagement, Telemonitoring