Florida Community-Engaged Research Alliance (FL-CEAL)

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Miami
Study ID
NCT06829485
Status
Recruiting

Conditions

  • Health, Subjective

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Sep 2025
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Community Health worker Group
    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
  • Active Comparator: Educational material group
    Participants in this group will be provided with educational material on health resources for up to 6 months

Primary Outcome Measure

Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI) [ Time Frame: Baseline, 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611
Elizabeth Shenkman, PhD
352-265-7220
Carrasquillo, MD
(305) 243-5096
Elizabeth Shenkman, PhD (SUB_INVESTIGATOR)
Mayo Clinic Florida Comprehensive Cancer CenterJacksonvilleFlorida32224
Odedina Folakemi, PhD
904-953-0853
Olveen Carrasquillo, MD
3052435096
Odedina Folakemi, PhD (SUB_INVESTIGATOR)
Florida International UniversityMiamiFlorida33136
Patria Rojas, PhD
305-348-7352
Olveen Carrasquillo, MD
(305) 243-5096
Patria Rojas, PhD (SUB_INVESTIGATOR)
Health Choice NetworkMiamiFlorida33137
Katherine Chung-Bridges, MD, MPH
305-392-8065
Olveen Carrasquillo, MD
(305) 243-5096
Katherine Chung-Bridges, MD, MPH (SUB_INVESTIGATOR)
Healthy Little HavanaMiamiFlorida33130
Islara X Souto
786-391-4061
Olveen Carrasquillo, MD MPH
3052439765
Islara X Souto (SUB_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Ana Riccio
305-243-4480
Victor Cueto (SUB_INVESTIGATOR)
Olveen Carrasquillo (PRINCIPAL_INVESTIGATOR)
Florida A&M UniversityTallahasseeFlorida32307
Cynthia Harris, PhD
850-599-3301
Olveen Carrasquillo, MD
(305) 243-5096
Cynthia Harris, PhD (SUB_INVESTIGATOR)
Sandra Suther, PhD (SUB_INVESTIGATOR)

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