search
Back to results

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

Primary Purpose

Health Services Administration, Telemedicine, Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Telemonitoring
Usual Care without Telemonitoring
Sponsored by
Les Laboratoires des Médicaments Stériles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Health Services Administration focused on measuring Telecommunication, Telecare, Teleconsult, Telemanagement, Telemonitoring

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fattouma Bourguiba HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Telemonitoring

Conventional

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
percentage of blood pressure load
The change of blood pressure load's percentages between baseline and 6 months of follow-up
percentage of Dipping
The change of dipping percentages between baseline and 6 months of follow-up
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
frequency of cardiovascular complications
Clinical outcomes including hospitalization rate, emergency room admissions related to high blood pressure, adverse effects, or other reasons

Full Information

First Posted
October 22, 2020
Last Updated
November 20, 2020
Sponsor
Les Laboratoires des Médicaments Stériles
search

1. Study Identification

Unique Protocol Identification Number
NCT04607239
Brief Title
The Impact of Telemonitoring in the Management of Hypertension
Acronym
HOROSCOPE
Official Title
HOme telemonitoRing of Arterial hypertensiOn With antihypertenSive Treatment Titration: a Randomized COntrolled prosPEctive Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 4, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Les Laboratoires des Médicaments Stériles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Services Administration, Telemedicine, Hypertension
Keywords
Telecommunication, Telecare, Teleconsult, Telemanagement, Telemonitoring

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The interventional group (Telemonitoring) in addition to the usual care group (conventional) will benefit from: a weekly telephone call for collection of home Blood Pressure measurements , therapeutic education & treatment compliance check a monthly call for treatment titration and side effects check
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemonitoring
Arm Type
Experimental
Arm 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.
Arm Title
Conventional
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Telemonitoring
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Usual Care without Telemonitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean of 24h systolic blood pressure (SBP)
Description
The change from baseline of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up
Time Frame
0 - 180 days
Secondary Outcome Measure Information:
Title
Mean of 24h diastolic blood pressure (DBP)
Description
The change from baseline of mean 24 hour diastolic blood pressure (DBP) at 6 months of follow-up
Time Frame
0-180 days
Title
percentage of blood pressure load
Description
The change of blood pressure load's percentages between baseline and 6 months of follow-up
Time Frame
0-180 days
Title
percentage of Dipping
Description
The change of dipping percentages between baseline and 6 months of follow-up
Time Frame
0-180 days
Title
Mean of the Short Form survey (SF-12) scores
Description
The change in the mean of SF-12 scores between baseline and 6 months of follow-up
Time Frame
0-180 days
Title
frequency of cardiovascular complications
Description
Clinical outcomes including hospitalization rate, emergency room admissions related to high blood pressure, adverse effects, or other reasons
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Semir NOUIRA, Prof
Phone
0021673106085
Email
semir.nouira@rns.tn
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia BEN HAFAIEDH, MD
Phone
0021698709311
Email
s.hafaiedh@medis.com.tn
Facility Information:
Facility Name
Fattouma Bourguiba Hospital
City
Monastir
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Semir NOUIRA, Prof
Phone
0021673106085
Email
semir.nouira@rns.tn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35230254
Citation
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.
Results Reference
derived

Learn more about this trial

The Impact of Telemonitoring in the Management of Hypertension

We'll reach out to this number within 24 hrs