Role of Depression in Blood Pressure Control. Study (TUN-BP-BLUE)

August 24, 2022 updated by: General Administration of Military Health, Tunisia

Role of Depression in Blood Pressure Control. A Cross-sectional Multicentric Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Research Problem: Hypertension is a multifactorial disease that affects approximately one quarter of the adult population. It is a major risk factor for stroke and cardiovascular disease.

Environmental and psychosocial factors play an important role in hypertension onset and control. The prevalence of depression among hypertensive patients is 26, 8% and its presence is associated with increased risk of cardiovascular-related morbi-mortality. Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients. Investigative process: This study is a cross-sectional, multicentric and descriptive study. the investigators intend to include three hundred and two patients. After obtaining their consent, a 24 hour ambulatory blood pressure monitor will be used to evaluate blood pressure control.

Depression was assessed by the 9-item-Patient Health Questionnaire (PHQ-9) in Tunisian dialect. Clinical, socio-environmental, psychosocial and therapeutic and prognosis data will be collected from medical records.

Study Type

Observational

Enrollment (Anticipated)

302

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

  • Tunisia
      • Ben Arous, Tunisia
        • Recruiting
        • Regional hospital of Ben Arous
        • Contact:
          • Jamila Habli, MD
      • Mahdia, Tunisia
        • Recruiting
        • Tahar Sfar regional hospital of Mahdia
        • Contact:
          • Hassen Ibn Hadj Amor, Pr
        • Sub-Investigator:
          • youssef ben youssef
      • Tunis, Tunisia, 1009
        • Recruiting
        • Military Hospital of Tunis
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yosra Raddaoui, fellow
    • Tunis
      • La Marsa, Tunis, Tunisia
        • Not yet recruiting
        • Interior Security Forces Hospital
        • Contact:
          • Saousen Antit, Pr
        • Sub-Investigator:
          • Yasmine Hajri

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients consulting for high blood pressure
  • Patients older than 18 years.
  • Patients able to give informed consent.

Non inclusion Criteria :

  • Patients followed for depression under treatment.
  • Hospitalized patients

Exclusion Criteria:

  • a white coat hypertension

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
To monitor the blood pressure during 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of depression in uncontrolled hypertensive patients.
Time Frame: on inclusion
The prevalence of depression evaluated by PHQ9 in Tunisian dialect in hypertensive patients with abnormal ambulatory 24 hours blood pressure monitoring
on inclusion

Collaborators and Investigators

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

Sponsor

General Administration of Military Health, Tunisia

Investigators

  • Principal Investigator: Aymen NOAMEN, MD, Military Hospital of Tunis
  • Study Chair: Wafa Fehri, Pr, Military Hospital of Tunis
  • Study Director: Lilia Zakhama, Pr, Interior Security Forces Hospital

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.

General Publications

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)

August 15, 2022

Primary Completion (Anticipated)

November 15, 2022

Study Completion (Anticipated)

January 15, 2023

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • santémilitaire10

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

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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