NCT00961974已完成不适用
Intensive Care Program for Youth With Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Glycemic control, assessed by hemoglobin A1c
研究概览
简要总结
The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with 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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-16 years
- •Type 1 diabetes diagnosed by standard American Diabetes Association criteria
- •Type 1 diabetes duration of at least 6 months
- •Residence in northeastern U.S.
- •Established clinic patient
- •Fluency in English or Spanish
排除标准
- •Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation)
- •Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)
结局指标
主要结局
Glycemic control, assessed by hemoglobin A1c
时间窗: Every 3 months
次要结局
- Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)(Annually)
- Weight, assessed by z-BMI (age- and gender-adjusted body mass index)(Every 3 months)
- Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia(Every 3 months)
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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