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临床试验/NCT06541210
NCT06541210招募中不适用

Building Community Living Labs (CoLLab) in Black Communities With the Goal of Advancing Prostate Health Equity and Reducing Prostate Cancer Disparities in Black Men

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
250
试验地点
2
主要终点
Create real-life user centric CoLLab Learning Health System (program production)

研究概览

简要总结

This clinical trial the possibility of establishing a Community Living Labs (CoLLab) Learning Health System to facilitate access to prostate health Risk, Education, and Assessment in the Community with Help (REACH) services in Black men and compares the impact to American Legion Posts with no CoLLab set up at the individual and community levels. Cancer is the second leading cause of death for Black men and Black men are less likely to receive prostate cancer screening. CoLLab Learning Health System utilizes community health workers (CHW) that are well-trained to form a bridge between communities and clinicians. In fact, Black men who work with CHW's typically have better access to health services, gain knowledge about cancer, cancer prevention, treatment and may have better overall health outcomes. Establishing a CoLLab Learning Health System at American Legion Posts may improve access to clinical trials and prostate cancer services in Black men.

详细描述

PRIMARY OBJECTIVES:

I. Co-create real-life user centric CoLLab Learning Health System at three American Legion Posts, compared to an American Legion Post with no CoLLab set-up. American Legion Post 197 will serve as the hub and Post 244 and Post 194 as the spokes.

II. Assess and evaluate the impact of the CoLLab Learning Health Systems compared to the comparison Post at the individual and community levels.

III. Explore the feasibility of replicating the CoLLab Learning Health System in Black communities nationally.

OUTLINE:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AIMS 1 AND 3: Participants must be one of the following key personnel:
  • Community PI (n=1),
  • CoLLab Program Manager (n=1)
  • CoLLab Site Managers (n=3)
  • CoLLab CAB members (n=21)
  • 2 Community Health Workers (CHWs) per Post site (n=6)
  • AIMS 1 AND 3: Between the ages of 21 and
  • AIMS 1 AND 3: Able to complete the survey in English.
  • AIMS 1 AND 3: Reside in the Jacksonville, FL and/or surrounding counties.
  • AIMS 1 AND 3: Willing and able to consent to the study.
  • AIM 2: Black adult of any gender.
  • AIM 2: Must be between the ages of 30 and
  • AIM 2: Able to speak English.
  • AIM 2: Reside in the Jacksonville, FL and/or surrounding counties.
  • AIM 2: Willing and able to consent to the study.

排除标准

  • AIMS 1 AND 3: Younger than 21years or older than 80 years.
  • AIMS 1 AND 3: Not a resident of NE Florida. Unwilling or unable to consent to the study.
  • AIM 2: Younger than 30 years or older than 80 years.
  • AIM 2: Not a resident of NE Florida.
  • AIM 2: Unwilling or unable to consent to the study.

结局指标

主要结局

Create real-life user centric CoLLab Learning Health System (program production)

时间窗: Up to 12 months

Qualitative data collection will be employed during a town hall meeting with the CoLLab Community Advisory Board (CAB) to ensure that we get unbiased and objective feedback from participants.

Impact of the CoLLab Learning Health Systems

时间窗: Baseline; up to 12 months

Will be assessed using pre-test and post-test survey scores from a Prostate Health Resources Questionnaire, which consists of 6 multiple choice questions, 8 true/false/don't know questions, 13 questions answered on a 5-point scale (e.g., very favorable to unfavorable or strongly agree to strongly disagree), and 20 yes/no questions.

Feasibility of Replication - cost analysis

时间窗: Up to 24 months

Will be assessed using cost analysis of direct and indirect costs.

Feasibility of Replication - qualitative

时间窗: Up to 24 months

Will be assessed qualitatively based on interviews of key personnel and users

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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