Pilot Study of A Cell-Phone System to Improve Health of Youth With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 6
- 主要终点
- Change from Baseline in HbA1c at 4 months
研究概览
简要总结
FL3X is an integrated diabetes self-management system that incorporates modern cell phone technology with behavioral modification approaches to improve diabetes self-management in high-risk youth. Utilizing such approaches will increase adherence to diabetes management behaviors and improve glucose control by providing increased autonomy over diabetes care.
详细描述
FL3X utilizes diabetes care providers (diabetes educators) as health coaches to employ behavioral modification techniques including motivational interviewing and problem solving skills training. Coaches help adolescents and their families learn these techniques to improve diabetes self management behaviors and diabetes care.
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
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes with duration at least 12 months
- •between ages 12-16 years at registration
- •poor glycemic control (A1c 8.0-13.0%)
- •parent/guardian willing to also participate
- •minority race/ethnicity
- •low income
排除标准
- •pregnant (if female)
- •diabetes type 2 or gestational
- •no health insurance
- •Pre-existing systemic chronic disease (drug abuse, cancer, psychiatric conditions)
结局指标
主要结局
Change from Baseline in HbA1c at 4 months
时间窗: 4 months
次要结局
- Change from Baseline in Quality of Life measures at 4 months(4 months)
研究者
Elizabeth Mayer-Davis, PhD
Professor
University of North Carolina, Chapel Hill