Actively Recruiting
Florida Community-Engaged Research Alliance (FL-CEAL) Study Evaluating Community Health Workers Versus Educational Materials For Supporting People with Non-Medical Health Challenges
Led by University of Miami · Updated on 2025-09-11
900
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to learn more about ways to support people facing non-medical challenges that affect their health. It focuses on whether Community Health Workers, who are local members providing basic health and medical assistance, can be more helpful than simply giving people educational materials to manage these issues on their own. Participants will be randomly assigned to one of two groups. One group will be connected with a Community Health Worker for up to six months, meeting at least three times either in person or virtually to receive personalized help with health challenges like food insecurity and accessing care. The other group will receive educational materials about health resources to review at their own pace. During the study, researchers will measure changes in participants' general well-being using the Personal Wellbeing Index at the start and after six months. They will also track changes in health insurance status, access to usual care, delays in medical care, and food insecurity. Participants' progress will be monitored over the six-month period to understand the impact of the support provided.
CONDITIONS
Brief Title
Florida Community-Engaged Research Alliance (FL-CEAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals living in the target community who do not plan to move out within the next six months
- Have at least two unmet social or health-related needs
- Age 18 or over for most sites except:
- Female minors aged 11-14 years at Florida A&M University/Mother Care Network
- Black/African American or Hispanic ethnicity at Florida A&M University/Mother Care Network
- Women aged 18 and over at University of Florida including pregnant and recently postpartum minority women
- Able to consent to participate
You will not qualify if you...
- Unable or unwilling to provide consent
- Plans to move out of the community during the next six months
- Enrolled in a research study addressing social determinants of health in the last three years
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months
Participants receive support through either community health workers or educational materials to help address non-medical health challenges.
At least 3 meetings with a community health worker or one-time receipt of educational materials
Trial Site Locations
Total: 7 locations
1
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
2
Mayo Clinic Florida Comprehensive Cancer Center
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Healthy Little Havana
Miami, Florida, United States, 33130
Actively Recruiting
4
Florida International University
Miami, Florida, United States, 33136
Not Yet Recruiting
5
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
Health Choice Network
Miami, Florida, United States, 33137
Actively Recruiting
7
Florida A&M University
Tallahassee, Florida, United States, 32307
Not Yet Recruiting
Research Team
O
Olveen Carrasquillo, MD
V
Victor Cueto, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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