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临床试验/NCT06829485
NCT06829485招募中不适用

Florida Community-Engaged Research Alliance (FL-CEAL)

University of Miami14 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2025年3月31日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
14
主要终点
Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI)

时间窗: Baseline, 6 months

In the PWI, each item is rated on a 0-to-10 scale (0 = No satisfaction at all; 10 = Very satisfied).

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olveen Carrasquillo

Professor of Medicine

University of Miami

研究点 (14)

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