Florida Community-Engaged Research Alliance (FL-CEAL)
3 other identifiers
interventional
900
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2025
CompletedFirst Posted
Study publicly available on registry
February 17, 2025
CompletedStudy Start
First participant enrolled
March 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
September 11, 2025
September 1, 2025
3.7 years
February 11, 2025
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI)
In the PWI, each item is rated on a 0-to-10 scale (0 = No satisfaction at all; 10 = Very satisfied).
Baseline, 6 months
Secondary Outcomes (4)
Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4)
Baseline, 6 months
Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4)
Baseline, 6 months
Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4)
Baseline, 6 months
Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire
Baseline, 6 months
Study Arms (2)
Community Health worker Group
EXPERIMENTALParticipants 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 group
ACTIVE COMPARATORParticipants in this group will be provided with educational material on health resources for up to 6 months
Interventions
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
Participants will receive one time educational materials including information of existing health resources. Participants will be able to review materials at participant discretion.
Eligibility Criteria
You may qualify if:
- 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
- Age 18 and over
- Age 18 and over
- Age 21 and over
- Female minors between the ages 11-14 years
- Black/African American; Hispanic or Non-Hispanic ethnicity
- Women aged 18 and over
- Pregnant and recently post-partum minority women
You may not qualify if:
- 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 Determinants Of Health (SDOH) in the last three years.
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Westatcollaborator
Study Sites (7)
University of Florida
Gainesville, Florida, 32611, United States
Mayo Clinic Florida Comprehensive Cancer Center
Jacksonville, Florida, 32224, United States
Healthy Little Havana
Miami, Florida, 33130, United States
Florida International University
Miami, Florida, 33136, United States
University of Miami
Miami, Florida, 33136, United States
Health Choice Network
Miami, Florida, 33137, United States
Florida A&M University
Tallahassee, Florida, 32307, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olveen Carrasquillo, MD
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
February 11, 2025
First Posted
February 17, 2025
Study Start
March 31, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share