Translating Telephonic Diabetes Self-management Support to Primary Care Practice: The NYC Care Calls Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 812
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout New York City. The program will be implemented by the New York City Department of Health, through their Primary Care Improvement Project.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age and older
- •Receiving treatment for diabetes at selected primary care practices throughout New York City
- •Most recent HbA1c ≥ 7.5% (max 3 months prior to randomization)
- •Ability to speak and read English or Spanish (or someone in the household who will read to them)
- •Access to a telephone
- •Willing to give informed consent to participate and accept random assignment.
排除标准
- •Stated intention to move out of the New York City area during the next year
- •Mental incapacity (e.g., confusion) evident on first telephone contact by Department of Health staff
- •Treatment provider deems that the patient is inappropriate for the trial
研究组 & 干预措施
Telephonic Diabetes Self-Management Support
This group receives all the Educational Print Materials received by the comparison condition plus telephone calls from a health educator to provide tailored diabetes self-management training and support. Participants with significant emotional distress at baseline also receive additional calls focused on distress management.
干预措施: Telephonic Diabetes Self-Management Support (Behavioral)
Educational Print Materials
Participants randomized to this arm will receive print materials on diabetes, glycemic control, self-management, and distress/depression.
干预措施: Educational Print Materials (Other)
结局指标
主要结局
HbA1c
时间窗: Change from baseline at 12 months
Obtained from electronic medical record.
次要结局
- Medication Adherence(Change from baseline at 12 months)
- Diabetes-related distress(Change from baseline at 12 months)
- Depressive symptoms(Change from baseline at 12 months)
- Cholesterol(Baseline and 12 months)
- Diabetes Self-Management(Change from baseline at 12 months)
- Blood pressure(Baseline and 12 months)
研究者
Jeffrey Gonzalez
Associate Professor
Albert Einstein College of Medicine