- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04124224
Unidos: Linking Individuals to Social Determinant and Community Health Services
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Latinos in Arizona, who are predominantly of Mexican-origin, are disproportionately affected by chronic disease and social conditions that contribute to health disparities. Important social determinants of health (SDH)--conditions where people live, work, and play--include barriers to healthy food, physical activity, poverty, discrimination, and housing instability as well as insufficient access to quality and culturally-responsive services. Such factors are increasingly recognized within primary care and population health as equal drivers of chronic disease and clinical indicators. Latino health is complex with not only disproportionate barriers, but also health advantages compared to other groups.
Recently, federally qualified health centers (FQHCs) have begun to incorporate assessments of their clients' SDH. With their foci on high-level clinical care for underserved populations, however, the capacity of these entities to respond to social and community needs is markedly limited. Community-clinical linkage (CCL) models provide opportunities for FQHCs to work collaboratively with other entities to leverage extant community resources and capacities. County health departments are uniquely positioned to collaborate with primary care partners and other community agencies to address social determinants.
Existing evidence of the effectiveness of CCLs in improving the health status of Latinos and their antecedent social conditions is scarce. The AzPRC will address this gap by executing a practice-based public health research study within four underserved, predominantly Mexican-origin communities. Our core research project, Unidos: Linking Individuals' to Social Determinant and Community Health Services, will result in a model CCL intervention to reduce chronic disease risk among Latinos in Arizona. Further, the investigators expect this intervention model to be applicable in other regions and populations. To execute this research, the AzPRC will implement the intervention in partnership with county health departments and FQHCs. In Unidos the county/community-based CHWs will: 1) support and connect participants to health promotion resources; 2) provide individual and group-based support guided by a novel framework for understanding Latino's health advantages, the sociocultural resiliency model; and, 3) leverage community resources to help individuals address SDH-related needs. The aims of this research study are to
- Implement and evaluate Unidos, a community-delivered, SDH-focused CHW intervention. The core elements of the evaluation will include community-responsive, mixed methodologies. Our hypothesis is that the Unidos intervention will reduce overall chronic disease risk, defined from the biological component from the American Heart Association's Life's Simple 7. A rigorous quasi-experimental design will be employed to determine Unidos' effect from electronic health records extracted 12 months after enrollment, with comparisons of clients participating vs not participating in the 6-month intervention. Exploratory analyses of cost effectiveness will be executed to further inform the scaling and sustainability of the intervention within local and county health department infrastructures.
- To test the sociocultural resilience model of Latino health advantages through the collection and analysis of longitudinal data that includes rich markers of reported health status, health behaviors, and psychosocial factors. The investigators have two hypotheses: a) the CHW-led, culturally embedded, intervention will lead to enhanced social support, social networks, health behaviors, quality of life and general health; and b) social support and social networks will mediate improvements in reported health observed over 6 months.
- A secondary aim is to examine whether our novel, CHW-administered assessments, contribute to the understanding of Latino health risk and advantages beyond a self-administered SDH tool that recently became integrated in the electronic health record (EHR) of two of our four clinical partners. The partners' use of this self-administered SDH tool is part of a national effort where select FQHCs across the country are testing whether it has utility for understanding and better addressing the population health needs of the patients they serve.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Abby M Lohr, MPH
- Phone Number: 5206263203
- Email: abbylohr@email.arizona.edu
Study Contact Backup
- Name: Maia Ingram, MPH
- Phone Number: (520) 626-2267
- Email: maiai@email.arizona.edu
Study Locations
-
-
Arizona
-
Nogales, Arizona, United States, 85621
- Not yet recruiting
- Mariposa Community Health Center
-
Contact:
- Cassalyn David, MPH
- Phone Number: 1370 520-375-6050
- Email: CDavid@mariposachc.net
-
Phoenix, Arizona, United States, 85012
- Not yet recruiting
- Maricopa County Health Department
-
Contact:
- Mark Gallegos
- Email: mark.gallegos@maricopa.gov
-
Phoenix, Arizona, United States, 85014
- Not yet recruiting
- Valle del Sol Community Health
-
Tucson, Arizona, United States, 85714
- Recruiting
- El Rio Community Health Center
-
Contact:
- Maria Velasco
- Phone Number: 520-309-4556
- Email: MariaV@elrio.org
-
Contact:
- Andres Yubeta
- Phone Number: (520) 670-3716
- Email: AndresY@elrio.org
-
Tucson, Arizona, United States, 85714
- Recruiting
- Pima County Health Department
-
Contact:
- Nic Cogdall, MPH, MPA
- Phone Number: 520-724-7714
- Email: nicholas.cogdall@pima.gov
-
Contact:
- Rebecca O'Brien
- Email: Rebecca.O'Brien@pima.gov
-
Yuma, Arizona, United States, 85364
- Recruiting
- Sunset Community Health Center
-
Contact:
- Lucy Murrieta
- Phone Number: 928-627-2051
- Email: lmurrieta@sunset-chc.org
-
Contact:
- Alma Valles
- Phone Number: 928-539-3153
- Email: AValles@sunset-chc.org
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Yuma, Arizona, United States, 85364
- Recruiting
- Yuma County Health District
-
Contact:
- Cynthia Espinoza, MD
- Phone Number: 928-317-4572
- Email: cynthia.espinoza@yumacountyaz.gov
-
Contact:
- Gloria Coronado, MA
- Phone Number: 928-317-4572
- Email: gloria.coronado@yumacountyaz.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult participants 18 years or older;
- Adults of Latino origin;
- Participants who speak either English or Spanish; and
- Participants who consent to participate in the study.
Exclusion Criteria:
- Excluded will be participants who do not consent to participate.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Unidos Participants
In the Unidos intervention the county/community-based CHWs will: 1) support and connect participants to health promotion resources; 2) provide individual and group-based support guided by a novel framework for understanding Latino's health advantages, the sociocultural resiliency model; and, 3) leverage community resources to help individuals address SDH-related needs.
|
The investigators will collaborate with our community partners to implement and evaluate a Community-Clinical Linkage (CCL) model in which Community Health Workers (CHWs) connect individuals to social determinant and community health services and build sociocultural resilience through CHW-facilitated individual and group support.
As a public health practice-based study that incorporates evidence-based strategies, the investigators seek to establish Unidos effectiveness in Arizona counties with the highest percentage of Latinos of Mexican origin (Yuma, Pima, Santa Cruz, and Maricopa).
Unidos CHWs, based in local health departments, will use evidence-based strategies to address three elements that are important in addressing chronic disease risk: 1) health promotion resources and programs; 2) individual and group-based social support; and 3) leveraging community resources to address social determinants of health.
|
Non-Unidos Participants: Comparison Group
Using propensity score matching, the investigators will use the medical records of Unidos participants and the electronic health record comparison group to compare health outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic Disease Risk
Time Frame: 9 months
|
Number of Participants with Chronic Disease Risk as Assessed by the American Heart Association Simple 7 (smoking, nutrition, physical activity, weight, blood pressure, cholesterol, and blood sugar) Change from Baseline in Simple 7 score at 3, 6, and 9 months.
|
9 months
|
Social Networks
Time Frame: 6 months
|
Number of Participants with Improved Social Networks as Assessed by the Berkman-Syme Network Index, Change from Baseline to 6 month follow-up.
|
6 months
|
Unidos Implementation within Local Health Departments
Time Frame: 2 months
|
Organizational readiness as assessed through qualitative data collection including focus groups and interviews.
|
2 months
|
Social Determinant of Health Factors
Time Frame: 6 months
|
Number of participants with improved Social Determinant of Health Factors as assessed by the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), change from baseline to 6 month follow-up.
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U48DP006413 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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