The Impact of Telemonitoring in the Management of Hypertension (HOROSCOPE)

Les Laboratoires des Médicaments Stériles

Status: Unknown

Conditions: Hypertension; Health Services Administration; Telemedicine

Treatments: Procedure: Usual Care without Telemonitoring; Procedure: Telemonitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT04607239

HTA-TELEMED

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

460 participants in 2 patient groups

Telemonitoring

Experimental group

Description:

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.

Treatment:

Procedure: Telemonitoring

Conventional

Other group

Description:

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.

Treatment:

Procedure: Usual Care without Telemonitoring