COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
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
- 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
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
Doyle M. Cummings
Professor of Family Medicine
East Carolina University
