NCT05516173

Brief Summary

Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients.

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
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 23, 2022

Last Update Submit

August 24, 2022

Conditions

Keywords

Patient Health QuestionnaireBlood Pressure Monitoring, Ambulatoryhypertensiondepression

Outcome Measures

Primary Outcomes (1)

  • prevalence of depression in uncontrolled hypertensive patients.

    The prevalence of depression evaluated by PHQ9 in Tunisian dialect in hypertensive patients with abnormal ambulatory 24 hours blood pressure monitoring

    on inclusion

Study Arms (1)

Ambulatory patients

Patient with a high blood pressure during regular visit will undertake an ambulatory blood pressure monitoring. Before wearing the device , they will be asked to answer to the questionnaire and the investigators will gather their demographic,clinical characteristics and dietary habits data. Ethical considerations will be undertaken and respected.

Diagnostic Test: Blood Pressure Monitoring, Ambulatory

Interventions

To monitor the blood pressure during 24 hours.

Ambulatory patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

outpatients consulting in the cardiology department in the different participating centers .

You may qualify if:

  • Patients consulting for high blood pressure
  • Patients older than 18 years.
  • Patients able to give informed consent.
  • Patients followed for depression under treatment.
  • Hospitalized patients

You may not qualify if:

  • a white coat hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Interior Security Forces Hospital

La Marsa, Tunis Governorate, Tunisia

NOT YET RECRUITING

Regional hospital of Ben Arous

Ben Arous, Tunisia

RECRUITING

Tahar Sfar regional hospital of Mahdia

Mahdia, Tunisia

RECRUITING

Military Hospital of Tunis

Tunis, 1009, Tunisia

RECRUITING

Related Publications (2)

  • Li Z, Li Y, Chen L, Chen P, Hu Y. Prevalence of Depression in Patients With Hypertension: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2015 Aug;94(31):e1317. doi: 10.1097/MD.0000000000001317.

  • Raddaoui Y, Ben Amara A, Noamen A, Antit S, Hajri Y, Habli J, Ibn Hadj Amor H, Ben Youssef Y, Zakhama L, Fehri W. Role of depression in blood pressure control. A cross-sectional multicentric study. Tunis Med. 2024 Jan 5;102(1):7-12. doi: 10.62438/tunismed.v102i1.4723. French.

MeSH Terms

Conditions

HypertensionDepression

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Blood Pressure DeterminationDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Aymen NOAMEN, MD

    Military Hospital of Tunis

    PRINCIPAL INVESTIGATOR
  • Wafa Fehri, Pr

    Military Hospital of Tunis

    STUDY CHAIR
  • Lilia Zakhama, Pr

    interior security forces hospital

    STUDY DIRECTOR

Central Study Contacts

Aymen NOAMEN, MD

CONTACT

Yosra Radaoui, fellow

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 25, 2022

Study Start

August 15, 2022

Primary Completion

November 15, 2022

Study Completion

January 15, 2023

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations