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临床试验/NCT05863884
NCT05863884已完成不适用

RADx-UP- Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake

Morehouse School of Medicine2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2022年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
2
主要终点
Blood Glucose Level

研究概览

简要总结

The proposed project will implement and evaluate a brief Community Health Worker (CHW) intervention through the Albany Area Primary Health Care, a rural Federally Qualified Health Center (FQHC). The primary goal of this study is to maximize effective outreach, education, and communication through CHWs in order to facilitate improved COVID-19 vaccine confidence and uptake in underserved and vulnerable communities. CHWs will be deployed to the homes of adults with increased risk of morbidity and mortality (i.e., African Americans or Latinos with uncontrolled diabetes or prediabetes, age <50 years, and non-COVID-19 vaccinated) in order to educate them about diabetes, COVID-19 and related vaccines. Health assessments, including blood glucose measurement, will be conducted on the indexed patient and offered to all other adult family members in the household (i.e., "bubble"). Adults with Type 2 diabetes likely live in households with other adults who have or are at increased risk for diabetes (i.e., prediabetes and obesity).1 It is expected that they will also share similar COVID-19 exposure risk. The specific aims are to: 1) Evaluate a community-driven education program to increase and enhance COVID-19 vaccine confidence and uptake in individuals with uncontrolled diabetes and their families (i.e., their "bubble") and 2) Evaluate a community-driven education program to improve diabetes self-management behaviors and related outcomes (e.g., blood glucose) in individuals with uncontrolled diabetes in rural, Southwest Georgia.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be between18 and 50 years
  • Self-identify as African American/Black or Latino
  • English speaking
  • Have received care for uncontrolled diabetes (HbA1c > 9%) or prediabetes diagnosis within one of the AAPHC 27 community sites
  • Unvaccinated for Phase 1 (vaccinated for Phase 2)

排除标准

  • Not meeting the Inclusion Criteria
  • Enrolled in the parent RADx-UP Project PEACH study
  • Unable or unwilling to provide informed consent to participate in the study (ie: incarcerated individuals and children)
  • Individuals with a terminal cancer diagnosis, have chronic kidney disease (stage 4-5), pregnant women, and people with severe psychological disorders (i.e., dementia,suicide ideation)

结局指标

主要结局

Blood Glucose Level

时间窗: 6 weeks

Change in HbA1c level from using clinical assessment parameters from week 1 to week 6.

次要结局

  • Diabetes Self-Management Score(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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