Combined Diabetes Education/Skills Training and Social Needs Resolution Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (DM Social Needs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Glycemic Control (Hemoglobin A1C [HbA1C])
研究概览
简要总结
This study will test the preliminary efficacy of a nurse case-manager, telephone-delivered intervention that provides diabetes self-management education and skills training and resolves the unmet social needs of older African Americans with poorly controlled type 2 diabetes by randomizing 100 African Americans aged 50 years and older with poorly controlled type 2 diabetes to the Combined Diabetes Education/Skills Training and Social Needs Resolution (DM Social Needs) Intervention (n=50) and usual care (n=50) arms.
The aims of this study are:
Aim 1: Test the preliminary efficacy of the DM Social Needs intervention on clinical outcomes in older AAs with uncontrolled type 2 diabetes.
Aim 2: Test the preliminary efficacy of the DM Social Needs intervention on patient reported outcomes in older AAs with uncontrolled type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 and older;
- •self-identified as African American or Black;
- •self-reported diagnosis of T2DM;
- •HbA1C >=8% at the screening visit.
排除标准
- •self-reported participation in other diabetes clinical trials;
- •alcohol or drug abuse or dependency as assessed by the CAGE-AID;
- •Mental confusion at screening assessment suggesting significant dementia;
- •life expectancy < 6 months at screening assessment.
研究组 & 干预措施
DM Social Needs Intervention
A trained health educator will deliver the manualized DM Social Needs intervention. Participants will receive 6-monthly sessions of diabetes education and skills training, and problem solving and resolution of social needs via telephone.
干预措施: DM Social Needs (Behavioral)
Usual Care
Participants in the usual care arm will receive mailed diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) monthly
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Glycemic Control (Hemoglobin A1C [HbA1C])
时间窗: Change in baseline HbA1C at 6 months post intervention follow-up
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for testing.
次要结局
未报告次要终点
研究者
Aprill Z. Dawson, PhD, MPH
Assistant Professor
Medical College of Wisconsin