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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 University1 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1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
1
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
否

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

研究组 & 干预措施

Integrated Behavioral Intervention

Experimental

Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.

干预措施: Integrated Behavioral Care (Behavioral)

Usual Care

No Intervention

Patients receive usual care

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 (1)

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