- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04607239
The Impact of Telemonitoring in the Management of Hypertension (HOROSCOPE)
HOme telemonitoRing of Arterial hypertensiOn With antihypertenSive Treatment Titration: a Randomized COntrolled prosPEctive Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Semir NOUIRA, Prof
- Phone Number: 0021673106085
- Email: semir.nouira@rns.tn
Study Contact Backup
- Name: Sonia BEN HAFAIEDH, MD
- Phone Number: 0021698709311
- Email: s.hafaiedh@medis.com.tn
Study Locations
-
-
-
Monastir, Tunisia
- Recruiting
- Fattouma Bourguiba Hospital
-
Contact:
- Semir NOUIRA, Prof
- Phone Number: 0021673106085
- Email: semir.nouira@rns.tn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
|
Other: 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. |
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean of 24h systolic blood pressure (SBP)
Time Frame: 0 - 180 days
|
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)
Time Frame: 0-180 days
|
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
Time Frame: 0-180 days
|
The change of blood pressure load's percentages between baseline and 6 months of follow-up
|
0-180 days
|
percentage of Dipping
Time Frame: 0-180 days
|
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
Time Frame: 0-180 days
|
The change in the mean of SF-12 scores between baseline and 6 months of follow-up
|
0-180 days
|
frequency of cardiovascular complications
Time Frame: 180 days
|
Clinical outcomes including hospitalization rate, emergency room admissions related to high blood pressure, adverse effects, or other reasons
|
180 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTA-TELEMED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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