NCT00745342已完成不适用
Optimizing Adherence and Glycemia in Youth With New IDDM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Glycemic control, assessed by hemoglobin A1c
研究概览
简要总结
This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.
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
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8 to 17 years old
- •Duration of type 1 diabetes between 2 months and 6 years
- •Residence in New England or New York
- •At least 1 outpatient visit in the past year
排除标准
- •Major co-morbid psychiatric or medical illness in youth
- •Diagnosis of an active major psychiatric disorder in either parent
- •Diagnosis of a life-threatening medical illness in either parent
结局指标
主要结局
Glycemic control, assessed by hemoglobin A1c
时间窗: 2 years
Change in A1c from baseline to 2 years, measured every 3 months
次要结局
- Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey(2 years)
- Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions)(2 years)
- Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions)(2 years)
研究者
Lori Laffel
Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section
Joslin Diabetes Center
研究点 (2)
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