Florida Community-Engaged Research Alliance (FL-CEAL)

NCT06829485 — Not applicable, Recruiting, 900 participants, University of Miami

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RegistryNCT06829485
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, supportive care
Enrollment900 (Estimated)
SponsorUniversity of Miami (Other); collaborators: National Heart, Lung, and Blood Institute (NHLBI), Westat
ConditionsHealth, Subjective
InterventionsCommunity health workers (CHW), Educational Materials (Behavioral)
Datesstart 2025-03-31, primary completion 2028-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2025-02-17, last updated 2026-10-01
Locations7 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Health, Subjective All trials of Community health workers (CHW) All trials of Educational Materials

-Summary

The purpose of the study is learn more about ways to help people with non-medical issues that can affect participant health. The study team will examine if Community Health Workers, members of a community who provide basic health and medical care within communities, are more helpful to people with non-medical issues than simple reading materials on how participants can do it themselves.

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+Arms and interventions

ArmTypeInterventionsDescription
Community Health worker GroupExperimentalBehavioral: Community health workers (CHW)Participants in this group will be linked to a community health worker for up to 6 months and also be offered the opportunity to participate in group level activities
Educational material groupActive comparatorBehavioral: Educational MaterialsParticipants in this group will be provided with educational material on health resources for up to 6 months
  • Community health workers (CHW) (Behavioral): Participants will meet with a Community Health Worker (CHW) who will help facilitate and provide personalized navigation to existing resources for addressing health challenges such as food insecurity and access to care. CHW will meet with participants in person or virtually at least three times for approximately 15-60 minutes for over the six month period
  • Educational Materials (Behavioral): Participants will receive one time educational materials including information of existing health resources. Participants will be able to review materials at participant discretion.

+Outcome measures

Primary outcomes

  • Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI) [Baseline, 6 months]: In the PWI, each item is rated on a 0-to-10 scale (0 = No satisfaction at all; 10 = Very satisfied).

Secondary outcomes

  • Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4) [Baseline, 6 months]: Health insurance status will measured by the number of participants who answered yes to the health insurance status
  • Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4) [Baseline, 6 months]: Having a usual source of care will measured by the number of participants who answered yes to having usual source of care
  • Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4) [Baseline, 6 months]: Delayed medical care will measured by the number of participants who answered yes to having delayed medical care due the cost.
  • Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire [Baseline, 6 months]: Food security status is assigned as follows: Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale) Raw score 2-4-Low food security Raw score 5-6-Very low food security

+Eligibility

Sex: All, ages: 13 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Individuals living within the target community who do not plan to move out of the community within the next six months
* Having two un-met SDOH needs

Site Specific Inclusion Criteria:

University of Miami/ Healthy Little Havana Inclusion Criteria

* Age 18 and over

Health Choice Network/ Broward Community Health Center/ Genesis Community Health Center Inclusion Criteria

* Age 18 and over

Florida International University Inclusion Criteria -Latina Women Age 18 and over

Mayo Clinic Florida Inclusion Criteria

-Age 21 and over

Florida A\&M University/ Mother Care Network Inclusion Criteria

* Female minors between the ages 11-14 years
* Black/African American; Hispanic or Non-Hispanic ethnicity

University of Florida Inclusion Criteria

* Women aged 18 and over
* Pregnant and recently post-partum minority women

Exclusion Criteria:

* Are unable or unwilling to consent
* Plans to move out of the community during the next six months
* Enrollment in a research study addressing Social Determinants Of Health (SDOH) in the last three years.
* Prisoners

+Locations (7)

FacilityCityCountryStatus
University of FloridaGainesville, FloridaUnited StatesRecruiting
Mayo Clinic Florida Comprehensive Cancer CenterJacksonville, FloridaUnited StatesRecruiting
Healthy Little HavanaMiami, FloridaUnited StatesRecruiting
Florida International UniversityMiami, FloridaUnited StatesNot yet recruiting
University of MiamiMiami, FloridaUnited StatesRecruiting
Health Choice NetworkMiami, FloridaUnited StatesRecruiting
Florida A&M UniversityTallahassee, FloridaUnited StatesNot yet recruiting

+Investigators

+Funding

NIH grants: OT2HL158287