Identification and Treatment of Diabetes In Solid Organ Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)
研究概览
简要总结
The purpose of this study is to determine the influence of post-transplant diabetes on medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to 18 years of age and their families.
详细描述
This study seeks to understand how organ transplant patients are affected by the development of diabetes, and to test whether early diagnosis of diabetes and comprehensive professional support will:
- facilitate the adjustment of children and their families to the rigors of diabetes care
- improve adherence to medication regimens
- reduce acute complications of diabetes and organ rejection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of Children's Healthcare of Atlanta who have received a kidney, liver, or heart transplant
排除标准
- •Received a transplant after 18 years of age
- •Cognitively unable to participant as determined by the study team psychologist
- •Not receiving a solid organ transplant for kidney, liver, or heart
- •Declines participation invitation
研究组 & 干预措施
Participants
Participants will complete tests of glucose tolerance and psychosocial assessments, and will undergo medical history screening. Those children identified with diabetes and/or abnormal glucose tolerance will receive both diabetes self-management education and psychosocial support from a pediatric Certified Diabetes Educator (CDE) and a psychologist, respectively.
干预措施: Psychologist Support (Behavioral)
Participants
Participants will complete tests of glucose tolerance and psychosocial assessments, and will undergo medical history screening. Those children identified with diabetes and/or abnormal glucose tolerance will receive both diabetes self-management education and psychosocial support from a pediatric Certified Diabetes Educator (CDE) and a psychologist, respectively.
干预措施: Pediatric Certified Diabetes Educators (CDEs) Support (Behavioral)
结局指标
主要结局
Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)
时间窗: Baseline, interval, and end of participation (Up to 18 years of age)
The Pediatric Quality of Life Inventory Transplant Module (PedsQL) is a 15 minute survey intended to measure emotional and physical function in children and determine state of wellbeing.
次要结局
- Rate of Vascular Disease Post Diabetes Diagnosis(Up to three years)
- Transplant Rejection Rate Post Diabetes Diagnosis(Up to three years)
- Change in the Children Depression Inventory (CDI 2) Score(Baseline, interval, and end of participation (Up to 18 years))
- Mortality Rate Post Diabetes Diagnosis(Up to three years)
- Change in the Wechsler Abbreviated Scale of Intelligence II (WASI-II) Score(Baseline, interval, and end of participation (Up to 18 years))
- Change in the Behavior Assessment System for Children (BASC) Score(Baseline, interval, and end of participation (Up to 18 years))
研究者
Jee-Young Nina Ham
Assistant Professor
Emory University