The Impact of Telemonitoring in the Management of Hypertension

Not Applicable

• Conditions: Telemedicine; Hypertension; Health Services Administration
• Interventions: Procedure: Telemonitoring; Procedure: Usual Care without Telemonitoring

• Registration Number: NCT04607239
• Lead Sponsor: Les Laboratoires des Médicaments Stériles

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-04
• Status Verified: 2020-10
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-29
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-24
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 460

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring	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.
Conventional	Usual Care without Telemonitoring	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.

Primary Outcome Measures

Name	Time	Method
Mean of 24h systolic blood pressure (SBP)	0 - 180 days	The change from baseline of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up

Secondary Outcome Measures

Name	Time	Method
Mean of 24h diastolic blood pressure (DBP)	0-180 days	The change from baseline of mean 24 hour diastolic blood pressure (DBP) at 6 months of follow-up
percentage of blood pressure load	0-180 days	The change of blood pressure load's percentages between baseline and 6 months of follow-up
percentage of Dipping	0-180 days	The change of dipping percentages between baseline and 6 months of follow-up
frequency of cardiovascular complications	180 days	Clinical outcomes including hospitalization rate, emergency room admissions related to high blood pressure, adverse effects, or other reasons
Mean of the Short Form survey (SF-12) scores	0-180 days	The change in the mean of SF-12 scores between baseline and 6 months of follow-up

Trial Locations

Locations (1)

Fattouma Bourguiba Hospital; 🇹🇳 Monastir, Tunisia