ECA vs E-Document Explanation
Embodied Conversational Agent as Consent Advocate Compared to E-Consent Administration
This study will investigate how consent forms and other health care documents are explained to patients. The findings will be used to create a computer program that can successfully explain consent and other health-related forms to individuals who have difficulty reading and understanding consent forms on their own as a supplement to the normal consent process done in research settings.
In a prior study, the investigators delivered a similar protocol, where subjects were first consented and then given a mock consent form (administered in 1 of 3 arms: RA, ECA, or ECA + RA). Subjects in this protocol struggled with the concept of a "mock" consent process, especially after they had just completed a consent process for the study itself. The current protocol, using deception research methods, aims to provide a more pure assessment of ECA consent vs the standard (here, E-consent) by waiving consent and delivering the sham consent as if it were reality. In the context of a protocol that employs deception methods, participants in the current study would be invited as healthy volunteers, and be randomized to 1 of 2 different consent processes to evaluate the relative benefits of different approaches for informed consent. After the knowledge tests have been completed, subjects will undergo a debriefing where they are made fully aware of the deception and its purpose. At that time, subjects will also be given the opportunity to "opt out" and not have their data included in the study results.
研究概览
详细说明
Participants who call in response to the clinic flyers will first confirm eligibility criteria of age (≥21) and language (able to complete a study visit in English). Once eligibility is confirmed, participants will be scheduled to come to BMC for a single study visit that will take approximately 60-90 minutes. Randomization to one study arm or the other will occur when subject arrives for appointment.
The following activities will occur at a single study visit:
- administer sham consent (via e-consent or ECA per randomization result)
- knowledge test
data collection
- socio-demographics
- health literacy assessment (REALM)
- ECA satisfaction (for ECA arm subjects only)
- Emotional connection (adapted PROMIS) (for ECA arm subjects only)
Debriefing
- Describe true study aims
- Opt out option (subject can request that their data not be used)
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02118
- Boston Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- English speaking
- able to come in for a single study visit
Exclusion Criteria:
- Deaf
- Blind
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:E-Consent
This arm is the standard of care, where the consent form is presented to the subject on a computer screen and he/she can scroll ahead and back as needed.
There is also an option to have each screen read aloud.
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实验性的:ECA Consent
In this arm an Embodied Conversational Agent (ECA) which is a computer generated character reads the consent form aloud to the subject, and also describes each section using a pre-loaded script.
In addition, the character performs "teach-back", where she asks the subject a question about the section that was just described, and then repeats the section if the question is answered incorrectly.
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The Embodied Conversational Agent (ECA) is a computer generated character that can interact with study subjects through a touch screen computer.
The ECA is programmed to respond with relevant speech and body language to a subject's responses.
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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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Knowledge of informed consent document
大体时间:immediately following the study interview
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A knowledge test will be given to assess the subjects' level of comprehension of the informed consent form
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immediately following the study interview
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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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Survey of level of satisfaction with the ECA
大体时间:immediately following the study interview
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For subjects in the ECA study arm, satisfaction with the agent will be assessed
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immediately following the study interview
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Amount of time spent on consent process
大体时间:immediately following the study interview
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The amount of time that the subject spent with the consent form, assessed in both arms
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immediately following the study interview
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- H-37101
- R01CA158219-05 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.
Embodied Conversational Agent的临床试验
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Hemoteq AG完全的冠状动脉疾病 | 冠状动脉硬化 | 冠状动脉粥样硬化 | 冠状动脉再狭窄德国, 法国