Identification and Treatment of Diabetes In Solid Organ Transplant Recipients
2020年12月7日 更新者：Jee-Young Nina Ham、Emory University
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
65
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- Emory Children's Center
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Atlanta、Georgia、美国、30322
- Children's Healthcare of Atlanta-Egleston
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients of Children's Healthcare of Atlanta who have received a kidney, liver, or heart transplant
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：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.
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Participants will complete several psychological questionnaires that are intended to cover a broad spectrum of physical, mental, and emotional aspects of the health of participants; the Behavior Assessment System for Children (BASC) ,the Children Depression Inventory (CDI 2), the Pediatric Quality of Life Inventory Transplant Module (PedsQL), and the Wechsler Abbreviated Scale of Intelligence II (WASI-II).
Data gathered from this testing will be used to guide the provision of psychological care to address psychosocial challenges inherent to the care of children with transplant related diabetes.
Pediatric Certified Diabetes Educators (CDEs) are specially trained to teach diabetes self-management to children and their families.
Participants who are diagnosed with diabetes will receive individualized support from a CDE in conjunction with their routine transplant care.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)
大体时间：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.
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Baseline, interval, and end of participation (Up to 18 years of age)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Transplant Rejection Rate Post Diabetes Diagnosis
大体时间：Up to three years
|
Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of transplant rejection after being diagnosed with diabetes.
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Up to three years
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Rate of Vascular Disease Post Diabetes Diagnosis
大体时间：Up to three years
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Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of vascular disease after being diagnosed with diabetes.
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Up to three years
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Mortality Rate Post Diabetes Diagnosis
大体时间：Up to three years
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Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of mortality after being diagnosed with diabetes.
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Up to three years
|
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Change in the Wechsler Abbreviated Scale of Intelligence II (WASI-II) Score
大体时间：Baseline, interval, and end of participation (Up to 18 years)
|
The Wechsler Abbreviated Scale of Intelligence II (WASI-II) is intended to determine cognitive ability for use in educational, as well as clinical and research settings.
The WASI-II is ideal for any subject over the age of six, and takes approximately one hour to complete.
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Baseline, interval, and end of participation (Up to 18 years)
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Change in the Children Depression Inventory (CDI 2) Score
大体时间：Baseline, interval, and end of participation (Up to 18 years)
|
The Children Depression Inventory (CDI 2) is a short ten minute self-reported survey intended to aid in the assessment of signs of depression in children ages seven through 17.
This test helps determine negative mood, poor self-esteem, a loss of interest in activities, interpersonal problems, and feelings of ineffectiveness, the common traits of depression.
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Baseline, interval, and end of participation (Up to 18 years)
|
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Change in the Behavior Assessment System for Children (BASC) Score
大体时间：Baseline, interval, and end of participation (Up to 18 years)
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The Behavior Assessment System for Children (BASC) takes approximately 15 minutes to complete and is intended to determine emotional and behavioral change in children, as well as to indicate risks to their health and development
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Baseline, interval, and end of participation (Up to 18 years)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nina Ham, MD、Emory University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年7月7日
初级完成 (实际的)
2018年11月14日
研究完成 (实际的)
2018年11月14日
研究注册日期
首次提交
2015年10月6日
首先提交符合 QC 标准的
2015年11月12日
首次发布 (估计)
2015年11月16日
研究记录更新
最后更新发布 (实际的)
2020年12月9日
上次提交的符合 QC 标准的更新
2020年12月7日
最后验证
2020年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.