Diabetes Management Program for Hispanic/Latino
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.
详细描述
The investigators propose a multiphase mixed method, Comparative Effectiveness Research Randomized Control Trial (CER RCT) to:
Specific Aim 1: Assess usability of an evidence-based DTM intervention utilizing a Community Based Participatory Research (CBPR) approach and adapt it to facilitate acceptability and feasibility in a population of H/L patients with T2D, and their caregivers and providers.
Specific Aim 2: Assess whether H/L patients receiving DTM attain significantly improved patient-centered outcomes compared to COM, through a CER RCT. Expected outcomes include improved diabetes quality of life (QoL), glucose management (GM), blood pressure (BP), cholesterol, medication adherence, and diabetes self-efficacy (SE), and reduced diabetes distress, problem areas in diabetes (PAID), inpatient utilization, unscheduled T2D physician visits and sick days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hispanic patients with a diagnosis of diabetes
- •Speaks English or Spanish
排除标准
- •Patient is not Hispanic
- •Patient does not have a diagnosis of diabetes
结局指标
主要结局
Hemoglobin A1C
时间窗: 6 months
HbA1c
次要结局
- Blood Pressure(6 months)
- Adherence(6 months)
- Weight(6 months)
- Cholesterol(6 months)
- Diabetes Quality of life(6 months)
- HbA1c(12 months)
- Hypoglycemia episodes(6 months)
- Diabetes self-efficacy(6 months)
- PAID(6 months)