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The Role of Social Determinants in Cardiovascular Health and Vascular Function

Not Applicable
Recruiting
Conditions
Cardiovascular Diseases
Major Depressive Disorder
Social Determinants of Health
Interventions
Other: Screening
Registration Number
NCT05772221
Lead Sponsor
Baylor Research Institute
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Interviewer-AdministeredScreeningScreening assessments to measure social determinants of health in relation to cardiovascular disease.
Primary Outcome Measures
NameTimeMethod
Generalized Anxiety Disorder-7 (GAD-7)1 year

The GAD-7 is a seven-item self-report scale for identifying the presence of generalized anxiety disorder (GAD) and assessing symptom severity. The items of the GAD- 7 are based on the diagnostic criteria for GAD in the DSM-IV and assess frequency of symptoms over the last two weeks. A score of 10 or greater on the GAD-7 represents a point for identifying cases of GAD. Cut points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety, respectively.

Perceived Stress Scale1 Year

The Perceived Stress Scale is a 10-item questionnaire widely used to assess stress levels in young people and adults aged 12 and above. It evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable, and overloading over the previous month. Higher scores indicate higher levels of perceived stress.

Quality of Life (WHOQOL-BREF)1 year

The WHOQOL-BREF is a 26-item quality of life assessment. It looks at the domains of physical health, psychological, social relationships, and environment. The four domain scores denote an individual's perception of quality of life in each particular domain.

PTSD Checklist for DSM-V (PCL-5)1 year

The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Initial research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD across samples.

Social Isolation1 year

Is a 3-item scale used to assess feelings of loneliness or social isolation. Each item has a minimum score of 1 and a maximum score of 3. The higher scores indicate a greater degree of loneliness.

Adverse Childhood Experiences (ACE)1 year

ACE is a 10-item measure used to measure childhood trauma. This questionnaire assesses 10 types of trauma, 5 being personal, physical abuse, verbal abuse, sexual abuse, physical neglect, and emotional neglect and 5 related to family members.

Pittsburgh Sleep Quality Index (PSQI)1 year

PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a one-month period. This measure assesses the following subcategories, sleep quality, latency, duration, habitual sleep efficiency, disturbances use of sleep medication, and daytime dysfunction.

Patient Health Questionnaire (PHQ-9)1 year

The PHQ-9 is a self-report measure that assesses the frequency of symptoms on each of the nine DSM-IV criteria for depression for "the last two weeks.". Total scores of 5-9 represent mild depression, 10-14 represent moderate depression, 15-19 represent moderately severe depression, and \> 20 represent severe depression.

WHODAS 2.0 (World Health Organization Disability Assessment Schedule)1 year

The WHODAS is a 36-item version, self- administered assessment. This measure assesses disability across dix domains, including understanding and communicating, getting around, self-care, getting along with people, lie activities, and participation in society.

International Physical Activity Questionnaire (IPAQ)1 year

The IPAQ is a 27-item long form, assessing physical activity over the last 7 days. This measure looks at job-related physical activity, transportation physical activity, housework, house maintenance, and caring for family, recreation, sport, and leisure-time physical activity, and time spent sitting.

Tobacco, Alcohol, Prescription drug, and illicit Substance use Electronic Spanish Platform (TAPS-ESP)1 year

TAPS is a two-stage screening and brief assessment tool that first screens the four broad substance abuse categories (tobacco, alcohol, prescription drug misuse, and illicit substances), then branches to the brief assessment in which the individual is assessed for more specific risks related to an expanded array of substances (tobacco, alcohol, cannabis, cocaine, methamphetamines, prescription stimulants, heroin, prescription opioids, sedatives, and other substances).

AAFP Social Needs Screening Tool1 year

This tool is a 15-item questionnaire about a participant's social needs. Social need categories measured by this instrument include housing, food, childcare, employment, education, finances, personal safety, and assistance. Scoring of this instrument highlights areas in an individual's life where there may be a social need.

MacArthur Scale of Subjective Social Status1 year

The MacArthur Scale of Subjective Social Status (MacArthur SSS Scale) is a two-item measure that assesses a person's perceived rank relative to others in their group. Respondents view a drawing of a ladder with 10 rungs, and either read or hear that the ladder represents where people stand in society.

Connor-Davidson Resilience Scale (CD-RISC-10)1 year

CD-RISC-10 is a 10-item self-report scale measuring resilience. This scale measures resilience and how well an individual is equipped to bounce back after stressful events, tragedy, or trauma. Each item has a minimum score of 0 and a maximum score of 4. Total scores range from 0 to 40. A higher score indicates higher resilience.

Experiences of Discrimination (EOD)1 year

The EOD is a short self-report instrument. It looks at individuals self-reported experiences of discrimination. Experiences of discrimination categories measures by this instrument include worry questions, global questions, filed complaints, major discrimination, day-to-day unfair treatment, and response to unfair treatment.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Baylor Scott & White Family Health Center at Juanita J. Craft Recreation Center

🇺🇸

Dallas, Texas, United States

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