Chatbot Implementation In The Clinical Informed Consent Process
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to determine the feasibility of implementing the chatbot "CoCo" in the IC process for research studies. We hypothesize that implementing a chatbot into the IC process will facilitate accurate information delivery and enhance participant comprehension and process satisfaction compared to traditional remote consent methods.
详细描述
Primary Objectives:
• To determine the feasibility of implementing a chatbot-facilitated remote informed consent (IC) process.
Secondary Objectives
- To identify determinants of patient acceptance and usage of the chatbot.
- To determine the accuracy and completeness of information delivered via the chatbot.
- To determine the quality of the chatbot-facilitated remote IC process.
- To determine the feasibility of using the chatbot for patient eligibility verification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Ability to understand and willingness to provide informed consent.
- •Age ≥18 years.
- •Patients whose preferred language is English.
- •Patients who are being considered for enrollment in selected clinical research studies.
- •Phase I will be initiated using the Clearinghouse protocol PA11-0852, a non-interventional biomarker study.
排除标准
- 未提供
研究组 & 干预措施
Phase I Feasibility Cohort: Remote IC Process for Non-Therapeutic Studies
All participants will be provided with an abbreviated informed consent form describing this study and providing sufficient information for patients to make an informed decision regarding participation.
干预措施: CoCo Chatbot (Other)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点