Chronic DiseaseNCT04124224
Unidos: Linking Individuals to Social Determinant and Community Health Services
An observational study of Chronic Disease and Community Health Workers, run by University of Arizona at 7 sites in United States.
Trial summary
For 19 years, the Centers for Disease Control and Prevention-funded Arizona Prevention Research Center (AzPRC) has been engaged in academic community collaborative research to reduce chronic disease health disparities among the Latino border communities in Arizona. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Community Health Workers
- What is being tested?
- Unidos
- How many people
- 400 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Sep 2020to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Arizona counties with significant Latino populations experience underlying social and economic disparities that place them at risk for chronic disease and negative health outcomes. The participating Maricopa, Pima, Yuma, and Santa Cruz counties are where a significant number of the Latino population for the state reside. Compared to the US population, communities in Arizona with a higher percentages of Latinos are more likely to face poverty, be uninsured, and have chronic disease risks.
Who may be able to join
- 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.
Who cannot join
- Excluded will be participants who do not consent to participate.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Not yet recruiting
Mariposa Community Health Center
Nogales, Arizona, 85621
Cassalyn David, MPH, 520-375-6050 ext. 1370, CDavid@mariposachc.net
- Not yet recruiting
Maricopa County Health Department
Phoenix, Arizona, 85012
Mark Gallegos, mark.gallegos@maricopa.gov
- Not yet recruiting
Valle del Sol Community Health
Phoenix, Arizona, 85014
- Recruiting
El Rio Community Health Center
Tucson, Arizona, 85714
Maria Velasco, 520-309-4556, MariaV@elrio.org
Andres Yubeta, (520) 670-3716, AndresY@elrio.org
- Recruiting
Pima County Health Department
Tucson, Arizona, 85714
Nic Cogdall, MPH, MPA, 520-724-7714, nicholas.cogdall@pima.gov
Rebecca O'Brien, Rebecca.O'Brien@pima.gov
- Recruiting
Sunset Community Health Center
Yuma, Arizona, 85364
Lucy Murrieta, 928-627-2051, lmurrieta@sunset-chc.org
Alma Valles, 928-539-3153, AValles@sunset-chc.org
- Recruiting
Yuma County Health District
Yuma, Arizona, 85364
Cynthia Espinoza, MD, 928-317-4572, cynthia.espinoza@yumacountyaz.gov
Gloria Coronado, MA, 928-317-4572, gloria.coronado@yumacountyaz.gov
About this study
For 19 years, the Centers for Disease Control and Prevention-funded Arizona Prevention Research Center (AzPRC) has been engaged in academic community collaborative research to reduce chronic disease health disparities among the Latino border communities in Arizona. Our research project, Unidos: Linking Individuals' to Social Determinant and Community Health Services, will result in a model Community-Clinical Linkage 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 Federally Qualified Health Centers. 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.
Read the 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.
- Conditions
- Chronic Disease, Community Health Workers
- Being tested
- Unidos
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UnidosOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Unidos | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Chronic Disease Risk
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.
Measured: 9 months
Social Networks
Number of Participants with Improved Social Networks as Assessed by the Berkman-Syme Network Index, Change from Baseline to 6 month follow-up.
Measured: 6 months
Unidos Implementation within Local Health Departments
Organizational readiness as assessed through qualitative data collection including focus groups and interviews.
Measured: 2 months
Social Determinant of Health Factors
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start16 Sep 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- El Rio Community Health Center, Pima County Health Department, Yuma County Health District, Sunset Community Health Center, Maricopa County Health Department, Valle del Sol Community Health, Mariposa Community Health Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124224
- Sponsor's protocol ID
- U48DP006413
- Status last verified
- Nov 2020
- First submitted
- 3 Oct 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a community-based participatory research study, the investigators will work with our Community Action Board to determine what data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unidos: Linking Individuals to Social Determinant and Community Health Services
- ClinicalTrials.gov ID
- NCT04124224
- Acronym / sponsor ID
- U48DP006413
- Conditions
- Chronic Disease, Community Health Workers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- El Rio Community Health Center, Pima County Health Department, Yuma County Health District, Sunset Community Health Center, Maricopa County Health Department, Valle del Sol Community Health, Mariposa Community Health Center
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For 19 years, the Centers for Disease Control and Prevention-funded Arizona Prevention Research Center (AzPRC) has been engaged in academic community collaborative research to reduce chronic disease health disparities among the Latino border communities in Arizona. Our research project, Unidos: Linking Individuals' to Social Determinant and Community Health Services, will result in a model Community-Clinical Linkage 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 Federally Qualified Health Centers. 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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unidos Participants | – | Other: UnidosIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Arizona counties with significant Latino populations experience underlying social and economic disparities that place them at risk for chronic disease and negative health outcomes. The participating Maricopa, Pima, Yuma, and Santa Cruz counties are where a significant number of the Latino population for the state reside. Compared to the US population, communities in Arizona with a higher percentages of Latinos are more likely to face poverty, be uninsured, and have chronic disease risks.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Excluded will be participants who do not consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UnidosThe 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. | Other | Unidos Participants |
Primary outcome
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.
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.
Unidos Implementation within Local Health Departments
Time frame: 2 months
Organizational readiness as assessed through qualitative data collection including focus groups and interviews.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: No. As this is a community-based participatory research study, the investigators will work with our Community Action Board to determine what data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and Community Health Workers, run by University of Arizona at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abby M Lohr, MPH (5206263203, abbylohr@email.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Disease Risk (time frame: 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.