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
- 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
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
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
Doyle M. Cummings
Professor of Family Medicine
East Carolina University
