The Role of Social Determinants in Cardiovascular Health and Vascular Function

Cardiovascular Diseases Clinical Trial

— CVRRC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772221
• Other study ID #: 022-215
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Baylor Research Institute
• Contact: Brittany Meredith, MSW
• Phone: 214-865-2422
• Email: brittany.meredith[@]bswhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Social Determinants of Health

Intervention

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

Locations

Country	Name	City	State
United States	Baylor Scott & White Family Health Center at Juanita J. Craft Recreation Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	University of Texas-Arlington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (PHQ-9)	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.	1 year
Primary	Generalized Anxiety Disorder-7 (GAD-7)	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.	1 year
Primary	PTSD Checklist for DSM-V (PCL-5)	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.	1 year
Primary	Perceived Stress Scale	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.	1 Year
Primary	AAFP Social Needs Screening Tool	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.	1 year
Primary	MacArthur Scale of Subjective Social Status	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.	1 year
Primary	Quality of Life (WHOQOL-BREF)	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.	1 year
Primary	Experiences of Discrimination (EOD)	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.	1 year
Primary	WHODAS 2.0 (World Health Organization Disability Assessment Schedule)	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.	1 year
Primary	Social Isolation	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.	1 year
Primary	Adverse Childhood Experiences (ACE)	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.	1 year
Primary	Pittsburgh Sleep Quality Index (PSQI)	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.	1 year
Primary	International Physical Activity Questionnaire (IPAQ)	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.	1 year
Primary	Connor-Davidson Resilience Scale (CD-RISC-10)	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.	1 year
Primary	Tobacco, Alcohol, Prescription drug, and illicit Substance use Electronic Spanish Platform (TAPS-ESP)	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).	1 year