Skip to main content
Clinical Trials/NCT05772221
NCT05772221
Completed
Not Applicable

The Role of Social Determinants in Cardiovascular Health and Vascular Function in a Racial and Ethnic Minority Population at High Risk for Disparities

Baylor Research Institute1 site in 1 country105 target enrollmentJune 29, 2023

Overview

Phase
Not Applicable
Intervention
Screening
Conditions
Social Determinants of Health
Sponsor
Baylor Research Institute
Enrollment
105
Locations
1
Primary Endpoint
Generalized Anxiety Disorder-7 (GAD-7)
Status
Completed
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 29, 2023
End Date
November 22, 2023
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

Interviewer-Administered

Screening assessments to measure social determinants of health in relation to cardiovascular disease.

Intervention: Screening

Outcomes

Primary Outcomes

Generalized Anxiety Disorder-7 (GAD-7)

Time Frame: 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 Scale

Time Frame: 1 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)

Time Frame: 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)

Time Frame: 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 Isolation

Time Frame: 1 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Tool

Time Frame: 1 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 Status

Time Frame: 1 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)

Time Frame: 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)

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials