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

November 20, 2020 updated by: Les Laboratoires des Médicaments Stériles

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

460

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Monastir, Tunisia
        • Recruiting
        • Fattouma Bourguiba Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

  • 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.
Other: Conventional

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.

  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of 24h systolic blood pressure (SBP)
Time Frame: 0 - 180 days
The change from baseline of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up
0 - 180 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2020

Primary Completion (Anticipated)

July 30, 2021

Study Completion (Anticipated)

July 30, 2021

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTA-TELEMED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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