The Role of Social Determinants in Cardiovascular Health and Vascular Function (CVRRC)

January 23, 2026 updated by: Baylor Research Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75210
        • Baylor Scott & White Family Health Center at Juanita J. Craft Recreation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Interviewer-Administered
Screening assessments to measure social determinants of health in relation to cardiovascular disease.
Other: Screening
Screening assessments to measure social determinants of health in relation to cardiovascular disease.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year
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.
1 year
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.
1 Year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Texas at Arlington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine Sanchez, PhD, Baylor Scott and White Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 022-215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

One year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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