Florida Community-Engaged Research Alliance (FL-CEAL)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Miami
- Enrollment
- 900
- Locations
- 14
- Primary Endpoint
- Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: Community health workers (CHW) (Behavioral)
Educational material group
Participants in this group will be provided with educational material on health resources for up to 6 months
Intervention: Educational Materials (Behavioral)
Outcomes
Primary Outcomes
Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI)
Time Frame: 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)
- 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)
Investigators
Olveen Carrasquillo
Professor of Medicine
University of Miami