The Impact of Telemonitoring in the Management of Hypertension
NCT ID: NCT04607239
Last Updated: 2020-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
460 participants
INTERVENTIONAL
2020-07-04
2021-07-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 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
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Telemonitoring
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.
Telemonitoring
* 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.
Conventional
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.
Usual Care without Telemonitoring
* 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.
Interventions
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Telemonitoring
* 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 Telemonitoring
* 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 Criteria
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Inclusion Criteria
* age ≥ 35 years old
* newly diagnosed hypertention
* uncontrolled hypertention
Exclusion Criteria
* 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
35 Years
ALL
No
Sponsors
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Les Laboratoires des Médicaments Stériles
INDUSTRY
Responsible Party
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Locations
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Fattouma Bourguiba Hospital
Monastir, , Tunisia
Countries
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Central Contacts
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Facility Contacts
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Semir NOUIRA, Prof
Role: primary
References
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Ben Hafaiedh S, Ben Daya Y, Radoui AH, Bouchoucha M, Razgallah R, Nouira S. Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Protocol for a Randomized Controlled Prospective Trial (HOROSCOPE Study). JMIR Res Protoc. 2022 Mar 1;11(3):e26184. doi: 10.2196/26184.
Other Identifiers
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HTA-TELEMED
Identifier Type: -
Identifier Source: org_study_id