Clinical trial NCT05516173: Role of Depression in Blood Pressure Control. Study
Official title: Role of Depression in Blood Pressure Control. A Cross-sectional Multicentric Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Depression
Keywords: Patient Health Questionnaire
Blood Pressure Monitoring, Ambulatory
hypertension
depression
Lead sponsor: General Administration of Military Health, Tunisia
Sponsor class: NETWORK
First posted: 2022-08-25
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients consulting in the cardiology department in the different participating centers .

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of depression in uncontrolled hypertensive patients.
timeFrame: on inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Interior Security Forces Hospital
state: Tunis
city: Ben Arous
country: Tunisia
facility: Regional hospital of Ben Arous
city: Mahdia
country: Tunisia
facility: Tahar Sfar regional hospital of Mahdia
city: Tunis
country: Tunisia
facility: Military Hospital of Tunis
Study officials:
affiliation: Military Hospital of Tunis
name: Aymen NOAMEN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Military Hospital of Tunis
name: Wafa Fehri, Pr
role: STUDY_CHAIR
affiliation: interior security forces hospital
name: Lilia Zakhama, Pr
role: STUDY_DIRECTOR
References:
citation: 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.