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临床试验/NCT02863523
NCT02863523已完成不适用

COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes

East Carolina University2 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2014年9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
139
试验地点
2
主要终点
Change From Baseline in Glycosylated Hemoglobin (%)

研究概览

简要总结

The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression.

详细描述

The investigators plan to implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression. The investigators approach will combine practice-based medical and cognitive behavioral treatment with strong community-based support to immediately place the patient at the right level of intervention based on disease and severity and to step-up treatment intensity and follow-up if the initial response is inadequate. The practice-based component will use a care manager linked to medical, pharmacologic, and behavioral colleagues. The community based component will utilize community health workers to provide support and facilitate access to resources. Goals include: 1) implementing and evaluating the effectiveness of this intervention; 2) examining the impact of this approach on psychological mediators of improved glycosylated hemoglobin (HbA1c); and 3) building, sustaining, and disseminating a cost-effective care model.

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
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical Diagnosis of Type 2 diabetes mellitus
  • Glycosylated Hemoglobin (HbA1c) > 7.0 = Uncontrolled
  • Positive score on diabetes related distress 2 question screener and/or
  • Positive score on Patient Health Questionnaire (PHQ-2) 2 question screener

排除标准

  • a diagnosis [from billing records using International Classification of Disease, 9th Edition (ICD-9) codes] of:
  • advanced disease (e.g., end stage renal disease, advanced heart failure, blindness, metastatic cancer and including those who are in active treatment for cancer), or
  • alcoholism or
  • cognitive impairment, or
  • major psychiatric disease or
  • any type of physical or mental impairment that would preclude active participation

结局指标

主要结局

Change From Baseline in Glycosylated Hemoglobin (%)

时间窗: Baseline to 12 months

Change from baseline in HbA1c or glycosylated hemoglobin (%)

次要结局

  • Change From Baseline in Diabetes Regimen-Related Distress(Baseline to 12 months)

研究者

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

Doyle M. Cummings

Professor of Family Medicine

East Carolina University

研究点 (2)

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