NCT04607239

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

November 24, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

October 22, 2020

Last Update Submit

November 20, 2020

Conditions

Health Services AdministrationTelemedicineHypertension

Keywords

TelecommunicationTelecareTeleconsultTelemanagementTelemonitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Mean of 24h diastolic blood pressure (DBP)

    0-180 days

  • percentage of blood pressure load

    0-180 days

  • percentage of Dipping

    0-180 days

  • Mean of the Short Form survey (SF-12) scores

    0-180 days

  • frequency of cardiovascular complications

    180 days

Study Arms (2)

Telemonitoring

EXPERIMENTAL

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.

Procedure: Telemonitoring

Conventional

OTHER

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.

Procedure: Usual Care without Telemonitoring

Interventions

TelemonitoringPROCEDURE

* 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.

Telemonitoring
Usual Care without TelemonitoringPROCEDURE

* 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.

Conventional

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Included are patients with:
  • age ≥ 35 years old
  • newly diagnosed hypertention
  • uncontrolled hypertention

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fattouma Bourguiba Hospital

Monastir, Tunisia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35230254DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Semir NOUIRA, Prof

CONTACT

0021673106085semir.nouira@rns.tn

Sonia BEN HAFAIEDH, MD

CONTACT

0021698709311s.hafaiedh@medis.com.tn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 29, 2020

Study Start

July 4, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

November 24, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)