Skip to content

The Role of Social Determinants in Cardiovascular Health and Vascular Function

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05772221
Acronym
CVRRC
Enrollment
105
Registered
2023-03-16
Start date
2023-06-29
Completion date
2023-11-22
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Major Depressive Disorder, Social Determinants of Health

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.

Interventions

OTHERScreening

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

Sponsors

Baylor Research Institute
Lead SponsorOTHER
The University of Texas at Arlington
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9)1 yearThe 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.
Generalized Anxiety Disorder-7 (GAD-7)1 yearThe 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.
PTSD Checklist for DSM-V (PCL-5)1 yearThe 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.
Perceived Stress Scale1 YearThe 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.
AAFP Social Needs Screening Tool1 yearThis 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 yearThe 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.
Quality of Life (WHOQOL-BREF)1 yearThe 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.
Experiences of Discrimination (EOD)1 yearThe 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.
WHODAS 2.0 (World Health Organization Disability Assessment Schedule)1 yearThe 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.
Social Isolation1 yearIs 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 yearACE 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 yearPSQI 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.
International Physical Activity Questionnaire (IPAQ)1 yearThe 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.
Connor-Davidson Resilience Scale (CD-RISC-10)1 yearCD-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.
Tobacco, Alcohol, Prescription drug, and illicit Substance use Electronic Spanish Platform (TAPS-ESP)1 yearTAPS 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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKatherine Sanchez, PhD

Baylor Scott and White Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026