The Impact of Telemonitoring in the Management of Hypertension

Les Laboratoires des Médicaments Stériles460 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

460

Conditions

Health Services Administration Telemedicine Hypertension

Interventions

TelemonitoringPROCEDURE

* 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.

Usual Care without TelemonitoringPROCEDURE

* 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.

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Fattouma Bourguiba Hospital

Monastir, Tunisia

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 0 - 180 days

Secondary Outcomes

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

Time frame: 0-180 days

percentage of blood pressure load

The change of blood pressure load's percentages between baseline and 6 months of follow-up

Time frame: 0-180 days

percentage of Dipping

The change of dipping percentages between baseline and 6 months of follow-up

Time frame: 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

Time frame: 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

Time frame: 180 days

Central Contacts

Semir NOUIRA, Prof

CONTACT

0021673106085 semir.nouira@rns.tn

Sonia BEN HAFAIEDH, MD

CONTACT

0021698709311 s.hafaiedh@medis.com.tn

Data from ClinicalTrials.gov

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