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临床试验/NCT00800410
NCT00800410已完成2 期

A Pilot Randomized Diabetes Intervention Among Inner-city African American and Latino Adults

University of Michigan1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2004年9月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
183
试验地点
1
主要终点
Hemoglobin A1c

研究概览

简要总结

The objectives of the proposed study are to determine whether culturally diverse community residents with diabetes are willing to participate in our community health worker intervention using randomized controlled trial (RCT) methods and to explore and document effective processes and protocols for RCT methods in these communities. The investigators will examine retention rates, identify reasons for attrition through interviews and focus groups, and determine strategies for improving recruitment, retention, and intervention methods. As a secondary objective, the investigators will explore the potential impacts of the intervention for improving healthy lifestyles, diabetes self-management, and selected health outcomes of participants.

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
None

入排标准

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

入选标准

  • •At least 18 years of age
  • •Had physician-diagnosed type 2 diabetes
  • •Self-identified as African American or Latino/Hispanic
  • •Lived in the targeted zip codes.

排除标准

  • •Individuals who already had serious diabetes-related complications, such as blindness, amputated limbs, and kidney failure

研究组 & 干预措施

Information on community resources

No Intervention

Participants received information about free and publicly available community resources on healthy lifestyle activities

Community Health Worker services

Experimental

干预措施: Community Health Worker (CHW) services (Behavioral)

结局指标

主要结局

Hemoglobin A1c

时间窗: 6 months

次要结局

  • LDL cholesterol(6 months)
  • Blood pressure(6 months)
  • Diabetes self-management knowledge(6 months)
  • Diabetes Self Management and Self Care Activities (physical activity, healthy eating, glucose testing, medication taking, required screening tests/exams)(6 months)
  • Diabetes specific emotional distress(6 months)

研究者

申办方类型
Other

研究点 (1)

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