Role of Depression in Blood Pressure Control. Study

NCT ID: NCT05516173

Last Updated: 2022-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-01-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension Depression

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood Pressure Monitoring, Ambulatory

Intervention Type DIAGNOSTIC_TEST

To monitor the blood pressure during 24 hours.

Interventions

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Blood Pressure Monitoring, Ambulatory

To monitor the blood pressure during 24 hours.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* a white coat hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Administration of Military Health, Tunisia

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aymen NOAMEN, MD

Role: PRINCIPAL_INVESTIGATOR

Military Hospital of Tunis

Wafa Fehri, Pr

Role: STUDY_CHAIR

Military Hospital of Tunis

Lilia Zakhama, Pr

Role: STUDY_DIRECTOR

interior security forces hospital

Locations

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Interior Security Forces Hospital

La Marsa, Tunis Governorate, Tunisia

Site Status NOT_YET_RECRUITING

Regional hospital of Ben Arous

Ben Arous, , Tunisia

Site Status RECRUITING

Tahar Sfar regional hospital of Mahdia

Mahdia, , Tunisia

Site Status RECRUITING

Military Hospital of Tunis

Tunis, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Aymen NOAMEN, MD

Role: CONTACT

+21620215773

Yosra Radaoui, fellow

Role: CONTACT

+21695651675

Facility Contacts

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Saousen Antit, Pr

Role: primary

Jamila Habli, MD

Role: primary

Hassen Ibn Hadj Amor, Pr

Role: primary

Aymen NOAMEN, MD

Role: primary

+21620215773

Yosra Radaoui, fellow

Role: backup

+21695651675

References

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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.

Reference Type RESULT
PMID: 26252317 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38545723 (View on PubMed)

Other Identifiers

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santémilitaire10

Identifier Type: -

Identifier Source: org_study_id

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