Evaluation Study of Web-based Resource for Youth
2019年4月29日 更新者：Alison Parker、Innovation Research & Training
Web-based Resource for Youth About Clinical Research
This study will evaluate DigiKnowIt News, a web-based resource to educate youth about pediatric clinical research.
Youth will be randomly assigned to one of three groups (1.
Intervention Version A; 2) Intervention Version B; 3) Wait-list control).
研究概览
详细说明
Compared to the high numbers of clinical trials with adults, there are far fewer clinical trials with children and adolescents; highlighting the need for more clinical trials with pediatric populations.
Lacking in the area of pediatric clinical research are resources to educate children and adolescents about clinical research in fun, interactive, and developmentally appropriate ways.
Thus, a web-based resource, DigiKnowIt News, was developed for youth aged 8 to 14 years to educate youth about participating in pediatric clinical trials.
The web-based resource includes video spotlights, investigations, and electronic comic books.
The purpose of this study is to conduct a randomized controlled trial to determine the effectiveness of the web-based resource and examine its impact on youths' knowledge about pediatric clinical trials, self-efficacy about making decisions about participation in clinical research, and positive attitudes towards participation.
研究类型
介入性
注册 (实际的)
91
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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North Carolina
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Durham、North Carolina、美国、27713
- innovation Research & Training
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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 14年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Within the ages of 8 and 14 years of age
Exclusion Criteria:
- Does not speak English fluently, does not have access to a computer or tablet with internet connection, and or has participated in a clinical trial after kindergarten.
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention Version A
Youth will be asked to complete a version of DigiKnowIt News that includes investigations, comics, and spotlight videos that focus on four topic areas related to participating in clincial trials.
Version A will include an additional topic area.
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DigiKnowIt News is an online, interactive, multimedia web-based resource designed to educate youth about participating in clinical trials.
Youth will learn general information about clinical trials, their rights in a clinical trial, the good and not so good of participating in clinical trials, communication with others during a clinical trial, and specific types of procedures used in clinical trials (i.e., needles, scans).
DigiKnowIt News is web-based and youth can complete it at home, on their own time.
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实验性的：Intervention Version B
Youth will be asked to complete a version of DigiKnowIt News that includes investigations, comics, and spotlight videos that focus on four topic areas related to participating in clincial trials.
Version B will include an additional topic area (different than in Version A).
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DigiKnowIt News is an online, interactive, multimedia web-based resource designed to educate youth about participating in clinical trials.
Youth will learn general information about clinical trials, their rights in a clinical trial, the good and not so good of participating in clinical trials, communication with others during a clinical trial, and specific types of procedures used in clinical trials (i.e., needles, scans).
DigiKnowIt News is web-based and youth can complete it at home, on their own time.
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无干预：Wait-List Control
Youth will not have access to DigiKnowIt News until after the post-test timepoint.
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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 |
|---|---|---|
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Change in Knowledge about Clinical Research
大体时间：2 weeks
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Questions will assess youth's factual knowledge about clinical research using a multiple choice format.
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2 weeks
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Change in Attitudes toward Clinical Research
大体时间：2 weeks
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Questions will assess youth's attitudes toward pediatric clinical research on a 3-point Likert rating scale.
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2 weeks
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Change in Self-Efficacy for Making Decisions
大体时间：2 weeks
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Questions will assess youth's self-efficacy for making decisions using a 5-point Likert scale.
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2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Initiative-Taking
大体时间：2 weeks
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Questions will assess youth's initiative-taking using a 5-point Likert scale.
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2 weeks
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Changes in Hope
大体时间：2 weeks
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Questions will assess youth's perceptions of hope using a 6-point Likert scale.
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2 weeks
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Changes in Parent-Child Communication
大体时间：2 weeks
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Questions will assess youth's perceptions about the quality of communication in their parent-child relationship using a 5-point Likert scale.
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2 weeks
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Consumer Satisfaction
大体时间：1 day
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Questions will ask youth to reflect on their experiences with the web-based resource using 5-point Likert scales.
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1 day
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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。
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)
2018年5月24日
初级完成 (实际的)
2018年8月17日
研究完成 (实际的)
2018年8月17日
研究注册日期
首次提交
2018年5月7日
首先提交符合 QC 标准的
2018年5月18日
首次发布 (实际的)
2018年5月22日
研究记录更新
最后更新发布 (实际的)
2019年5月1日
上次提交的符合 QC 标准的更新
2019年4月29日
最后验证
2019年4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.
DigiKnowIt News的临床试验
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University Hospital, Angers尚未招聘
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Association pour la Formation l'Enseignement et...Collège de Médecine d'Urgence de la Région PACA (COPACAMU)完全的
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Aseer Central HospitalArmed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM); King Khalid University (KKU)完全的