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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring | Experimental | 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. |
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| Conventional | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring | Procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Included are patients with:
Exclusion Criteria:
Excluded are patients with:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Semir NOUIRA, Prof | Contact | 0021673106085 | semir.nouira@rns.tn | |
| Sonia BEN HAFAIEDH, MD | Contact | 0021698709311 | s.hafaiedh@medis.com.tn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fattouma Bourguiba Hospital | Recruiting | Monastir | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39695330 | Derived | Saafi M, Bel Haj Ali K, Dhaoui R, Toumia M, Sassi S, Bendaya Y, Bouchoucha M, Hafaeidh SB, Trabelsi I, Sekma A, Bakir A, Jaballah R, Yaakoubi H, Youssef R, Zorgati A, Beltaief K, Mezgar Z, Khrouf M, Sghaier A, Jerbi N, Razgallah R, Bouida W, Grissa MH, Saad J, Boubaker H, Dridi Z, Boukef R, Msolli MA, Nouira S; HOROSCOPE study group. Phone-based telemonitoring of arterial hypertension versus usual care: the HOROSCOPE study. Hypertens Res. 2025 Mar;48(3):1135-1143. doi: 10.1038/s41440-024-02018-6. Epub 2024 Dec 18. | |
| 35230254 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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The interventional group (Telemonitoring) in addition to the usual care group (conventional) will benefit from:
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|
| Usual Care without Telemonitoring | Procedure |
|
|
| 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 |
| Derived |
| 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. |