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临床试验/NCT02156037
NCT02156037已完成不适用

Case Management for Underserved Hispanic Type 2 Diabetes Populations

Baystate Medical Center2 个研究点 分布在 1 个国家目标入组 399 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
399
试验地点
2
主要终点
HbA1c

研究概览

简要总结

To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard.

详细描述

To compare a usual diabetes care condition (UDC) to a comprehensive diabetes care intervention condition (IC) involving a "diabetes dashboard" clinical decision support tool used by the diabetes team in primary care. The investigators used a parallel-groups randomized design. The diabetes team (i.e., diabetes nurses, diabetes dietitians, and providers) delivered a 5-visit, 6-month intervention to n=199 poorly-controlled (HbA1c >7.5%) Latino T2D patients (mean age=55 years, 60% female) seen at 2 urban community health centers. This intervention was compared to an established, in-house diabetes team care program (n=200) for its impact on blood glucose control and key psychosocial outcomes (diabetes distress, depression, social distress).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • age 18 years or older,
  • self-identified Hispanic ethnicity,
  • diagnosis of T2D,
  • HbA1c >7.5%, and
  • provider approval given for patient participation

排除标准

  • inability to consent,
  • pregnant or planning to become pregnant in the next year,
  • taking glucocorticoid therapy, or
  • having serious psychiatric or medical complications (e.g., late stage diabetes complications, seizures, dementia, psychiatric hospitalization) that would prevent participation in study activities.

结局指标

主要结局

HbA1c

时间窗: 6 months

Change in HbA1c over 6 months

次要结局

  • Depression(6 months)
  • Diabetes distress(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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