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临床试验/NCT02799407
NCT02799407撤回不适用

Electronic Consent of Numerous Subjects Employing Novel Techniques Trial

Duke University0 个研究点开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Participant comprehension, as measured by Qualtrics survey

研究概览

简要总结

The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form.

详细描述

The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form. Through this two-arm randomized controlled trial (RCT) 120 participants will be asked to read through either a ResearchKit multi-tiered consent form administered on an iPod Touch device or a standard long-form consent form administered via paper and give their informed consent for a sham research study on health tracking apps. The participants will then be asked to answer a short series of questions (5 minutes) about the consent process in order to measure their subjective and objective comprehension. The main risk from this study is loss of confidentiality of responses, however this risk should be minimal given that protected health information (PHI) will only be collected on the consent document and all information will be stored on Duke Box in a private folder only accessible by the study team.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Able to read and understand study materials which are presented in English
  • Owns or has access to a smartphone or other smart device such as a tablet or iPod

排除标准

  • Any physical limitations which prevent the participant from using mobile and/or touch screen technologies
  • Employed in a research position, clinical care position, or position which has regular exposure to clinical research

结局指标

主要结局

Participant comprehension, as measured by Qualtrics survey

时间窗: at study conclusion, an average of 15 minutes

Participants will complete a questionnaire about the consent form after reading through the consent which will assess their comprehension of the contents of the consent process.

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

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