Clinical trial NCT05772221: The Role of Social Determinants in Cardiovascular Health and Vascular Function
Official title: The Role of Social Determinants in Cardiovascular Health and Vascular Function in a Racial and Ethnic Minority Population at High Risk for Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Determinants of Health
Major Depressive Disorder
Cardiovascular Diseases
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: The University of Texas at Arlington
First posted: 2023-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study aims to identify the influence of social determinants of health domains on vascular function in a low income, racial, and ethnic minority population at risk for disparities. We hypothesize that individuals of a lower social economic position and those struggling with depression are at greater risk of cardiovascular disease.

Detailed description: This study aims to identify the influence of social determinants of health domains on vascular function in a low income, racial, and ethnic minority population at risk for disparities. We hypothesize that individuals of a lower social economic position are at greater risk of impairment in the large organ that is responsible for blood movement in the body and artery stiffness. Additional sims include identifying the influence of depression on vascular function and measure the interaction between depression and social determinants of health. We hypothesize that impairment will be greater in individuals with depression than in individuals without. Finally we will compare a comprehensive metabolic project against the social determinants of health and depression, hypothesizing that more severe social determinants of health and depression will increase the risk of cardiovascular disease.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older and ability to read.

Exclusion Criteria:

* (1) unable to provide informed consent (e.g., due to acute impairment or psychosis), (2) inability to read, (3) previously enrolled in the study.

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 1 year
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 1 year
measure: PTSD Checklist for DSM-V (PCL-5)
timeFrame: 1 year
measure: Perceived Stress Scale
timeFrame: 1 Year
measure: AAFP Social Needs Screening Tool
timeFrame: 1 year
measure: MacArthur Scale of Subjective Social Status
timeFrame: 1 year
measure: Quality of Life (WHOQOL-BREF)
timeFrame: 1 year
measure: Experiences of Discrimination (EOD)
timeFrame: 1 year
measure: WHODAS 2.0 (World Health Organization Disability Assessment Schedule)
timeFrame: 1 year
measure: Social Isolation
timeFrame: 1 year
measure: Adverse Childhood Experiences (ACE)
timeFrame: 1 year
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 year
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 1 year
measure: Connor-Davidson Resilience Scale (CD-RISC-10)
timeFrame: 1 year
measure: Tobacco, Alcohol, Prescription drug, and illicit Substance use Electronic Spanish Platform (TAPS-ESP)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Family Health Center at Juanita J. Craft Recreation Center
state: Texas
Study officials:
affiliation: Baylor Scott and White Research Institute
name: Katherine Sanchez, PhD
role: PRINCIPAL_INVESTIGATOR
References: