Florida Community-Engaged Research Alliance (FL-CEAL)

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (4)

• Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4) [Срок оценки: Baseline, 6 months]
• Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4) [Срок оценки: Baseline, 6 months]
• Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4) [Срок оценки: Baseline, 6 months]
• Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire [Срок оценки: Baseline, 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 7 центров

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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