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临床试验/NCT02668705
NCT02668705终止不适用

Research Ethics and Safety Promoted by Embodied Conversational Technology

Boston Medical Center1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
101
试验地点
1
主要终点
the quality of the informed consent process

研究概览

简要总结

Both the main and sub-studies 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.

详细描述

The main study in this protocol is a 3 arm (HUMAN vs. ECA vs. ECA + HUMAN), randomized, between-subjects experimental design.

There is one sub-study, the Images study, also included in this protocol. Subjects who are eligible for the main study can choose if they would like to participate in this sub-study. This is a within-subjects design, where subjects will be randomized to different conditions within the system.

One additional sub-study, called Stance, also a within-subjects design, where subjects will be randomized to different conditions within the system, was also included in the original protocol,but has since been closed to enrollment. Data collection for this sub-study was the same as for the current sub study (Images), and the main study (Consent Advocate).

Eligible subjects will be given the option to participate in the sub-study in addition to the main study. Subjects may opt out of this sub-study, but not the main study (as in, a subject cannot do the sub-study and NOT do the main study, unless there is some legitimate reason to stop after the sub-study). Due to the nature of the content, the order of the studies must be:

Images (sub) Consent Advocate (main) In these studies, baseline data is collected by the RA verbally administering the instruments to the subjects. Then, the subject will sit in front of a touch-screen monitor to interact with the character on the screen. A member of the research team will be available at all times to assist with any technical issues, or if the subject needs to take a break. Once the on-screen interaction(s) are complete, the RA will administer any post-system data collection instruments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

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

入选标准

  • •understand spoken and written English (assessed by verbally asking candidates if they "understand spoken and written English")
  • •Must be an established patient in the Boston Medical Center clinics.

排除标准

  • •An issue determined by the patient's physician that would make this study inappropriate.

研究组 & 干预措施

Human RA

No Intervention

A sham research informed consent form will be explained by a research assistant

ECA

Experimental

A sham research informed consent form will be explained by an ECA (embodied conversational agent as presented on a touch screen computer)

干预措施: Embodied Conversational Agent (Other)

ECA + Human RA

Experimental

A sham research informed consent form will be explained by an ECA and then questions will be answered by a research assistant

干预措施: Embodied Conversational Agent (Other)

结局指标

主要结局

the quality of the informed consent process

时间窗: immediately following the study interview

as determined by verbally administering the Brief Informed Consent Evaluation Protocol (BICEP) instrument.

次要结局

  • knowledge of the mock study that was described during study visit(immediately following the study interview)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Paasche-Orlow

BMC Attending Physician

Boston Medical Center

研究点 (1)

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