The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes (Edu4U)
2018年12月13日 更新者：Gwendolyn Pierce、University of Louisville
The purpose of this study is to determine whether a simple text message reminder sent to the parent of an child/adolescent with Type 1 Diabetes(or parent and adolescent) is effective in helping the individual(or parent) become more compliant with self-managing the Type 1 Diabetes (T1D).
There will be 5 arms: text message sent to parents of children age 8-12 years old with T1D, text messages sent to parents of adolescents ,age 13-18 years old, with T1D,text messages sent to parents of adolescents with T1D as well as the adolescent with T1D,no text message sent to parents of children age 8-12 years, and no text message sent to adolescents or parents of adolescents age 13-18 years old.
研究概览
详细说明
Managing Type 1 Diabetes requires daily checks of blood glucose and medication adjustments.
Children and adolescents are known to have more difficulty with this than adults.
Parents/legal guardians also face the task of helping with this self-management.
A weekly text message regarding Type 1 Diabetes, sent to the parent or the parent and adolescent, may help to remind and motivate an individual to perform the daily tasks needed to manage their Type 1 Diabetes.
研究类型
介入性
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
-
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Kentucky
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Louisville、Kentucky、美国、40202
- University of Louisville
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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
8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:
- Be willing to agree to participate(assent) in the study and have the permission of the parent to do so.
- Have a diagnosis of Type 1 diabetes for ≥ one year.
- Be aged 8 to 18 years old.
- Be on insulin therapy for ≥ one year.
- Have a parent/legal guardian with access to a working cell phone or have a parent/legal guardian with access to a working cell phone and have a working cell phone (if 13 years of age or older).
- Utilize one of the following mobile carriers: T-Mobile, Sprint, Verizon, AT&T, or Virgin Mobile.
- The parent/legal guardian must express intent to maintain a carrier plan for the duration of the study.
- The parent/legal guardian must be able to read English OR the parent/legal guardian and the adolescent must be able to read English.
Exclusion Criteria:
- Participants, who in the opinion of the investigator, have any contraindication to tight glycemic control.
- Individuals who are unable to undertake blood glucose testing during the study period
- Individuals who are deemed unable or unlikely to comply with the protocol.
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：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：8-12 years old, parent receiving text
text message to parent only
|
A weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year
其他名称：
|
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有源比较器：13-18 years old, parent receiving text
text message to parent only
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A weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year
其他名称：
|
|
有源比较器：13-18 years, both receiving text
Text message to parent and adolescent
|
A weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year
|
|
无干预：No text
No text will be sent
|
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 |
|---|---|---|
|
glycemic control assessed by HbA1C level.
大体时间：up to one year after randomization occurs
|
review of lab value
|
up to one year after randomization occurs
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
number of episodes of Diabetic Ketoacidosis (DKA)
大体时间：up to one year after randomization occurs
|
chart review of self reported episodes of Diabetic Ketoacidosis and chart review of hospitalizations related to DKA
|
up to one year after randomization occurs
|
|
number of episodes of severe hypoglycemia
大体时间：up to one year after randomization occurs
|
chart review of reported episodes of severe hypoglycemia and chart review of hospitalizations related to hypoglycemia
|
up to one year after randomization occurs
|
|
number of patient contacts to the diabetes educator
大体时间：up to one year after randomization occurs
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chart review of educator documentation of communication with subject
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up to one year after randomization occurs
|
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number of hospitalizations related to T1D
大体时间：up to one year after randomization occurs
|
chart review of hospitalizations related to T1D
|
up to one year after randomization occurs
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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：Gwendolyn S Pierce, MSN、University of Louisville
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 (预期的)
2019年3月1日
初级完成 (预期的)
2019年12月13日
研究完成 (预期的)
2019年12月13日
研究注册日期
首次提交
2015年6月8日
首先提交符合 QC 标准的
2015年11月30日
首次发布 (估计)
2015年12月2日
研究记录更新
最后更新发布 (实际的)
2018年12月17日
上次提交的符合 QC 标准的更新
2018年12月13日
最后验证
2018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.