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Recruiting NCT06829485

Florida Community-Engaged Research Alliance (FL-CEAL)

No phase Interventional Health, Subjective

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Community health workers (CHW), Educational Materials.
Who it may be relevant to
Registry conditions: Health, Subjective. Basic parameters: from 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Community health workers (CHW)
    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
  • Behavioral Educational Materials
    Participants will receive one time educational materials including information of existing health resources. Participants will be able to review materials at participant discretion.

Primary outcome measures

  • Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI) [Time frame: Baseline, 6 months]
Secondary outcome measures (4)
  • Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4) [Time frame: Baseline, 6 months]
  • Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4) [Time frame: Baseline, 6 months]
  • Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4) [Time frame: Baseline, 6 months]
  • Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire [Time frame: Baseline, 6 months]

Eligibility criteria

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 Determinants Of Health (SDOH) in the last three years.
  • Prisoners

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 7 centers
  • University of Florida — Gainesville
  • Mayo Clinic Florida Comprehensive Cancer Center — Jacksonville
  • Healthy Little Havana — Miami
  • Florida International University — Miami
  • University of Miami — Miami
  • Health Choice Network — Miami
  • Florida A&M University — Tallahassee

Identifiers

NCT: NCT06829485 · 20240463 · OT2HL158287 · 6922-03-COVID-S005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗