The Impact of Telemonitoring in the Management of Hypertension

Hypertension Clinical Trial

— HOROSCOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04607239
• Other study ID #: HTA-TELEMED
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: October 2020
• Source: Les Laboratoires des Médicaments Stériles
• Contact: Semir NOUIRA, Prof
• Phone: 0021673106085
• Email: semir.nouira[@]rns.tn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Services Administration
• Hypertension
• Telemedicine

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba Hospital	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
Les Laboratoires des Médicaments Stériles

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	percentage of blood pressure load	The change of blood pressure load's percentages between baseline and 6 months of follow-up	0-180 days
Secondary	percentage of Dipping	The change of dipping percentages between baseline and 6 months of follow-up	0-180 days
Secondary	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
Secondary	frequency of cardiovascular complications	Clinical outcomes including hospitalization rate, emergency room admissions related to high blood pressure, adverse effects, or other reasons	180 days