VALIDATE: Virtual Agent Linked Intelligent Disease Assessment Tool Engine
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percentage of participants satisfied with usage of VALIDATE
研究概览
简要总结
The collection and analysis of family, medical, lifestyle, and environmental exposure history (a Comprehensive Health History or "CHH") can identify critical risk factors for many chronic and life-threatening conditions, including cancer. Despite its importance, CHH is infrequently documented and analyzed in primary-care medical practice due to numerous hurdles, and currently available tools have proven inadequate to address this critical problem. This study will evaluate the Virtual Agent Linked Intelligent Disease Assessment Tool Engine ("VALIDATE") system as an easy to administer, accurate, cost-effective, and clinically useful tool for collecting and analyzing structured CHH data.
详细描述
Our study's objective is to evaluate the Virtual Agent Linked Intelligent Disease Assessment Tool Engine ("VALIDATE") system as a means to improve the affordability and ease, while maintaining the validity and feasibility, of collecting, assessing, and acting on Comprehensive Health History data.
Virtual Agents (VAs) are fully autonomous and embodied software agents that use both verbal (e.g. speech) and non-verbal modalities (e.g., gaze, gesturing) to simulate a clinician-patient encounter. These agents have already successfully shown advantages to patients for: entering family history data on their own, facilitating medication adherence, providing behavioral health information, serving as clinical interviewers, promoting breastfeeding, and educating about and motivating exercise and weight loss. The VALIDATE system has been developed to be a fully automated alternative to the currently extremely labor-intensive process of collecting and transcribing CHH data. VALIDATE will be evaluated for its capability to significantly diminish clinician time and cost to collect, review, analyze, and document accurate and complete certain CHH data directly from patients at home using their own personal desktop computers. VALIDATE will also be evaluated for its capability to identify valid clinical action, e.g. referral indications for familial cancer assessment based on American College of Medical Genetics and Genomics (ACMG)/National Society of Genetic Counselors (NSGC) and National Comprehensive Care Network (NCCN) Guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 是
入选标准
- •All adults above the age of 18
排除标准
- •Children under the age of 18
研究组 & 干预措施
VALIDATE subjects
Will be invited to interact with VALIDATE to determine if they meet referral indications for cancer predisposition assessment.
干预措施: VALIDATE system (Other)
Control
Current standard of care will be followed
结局指标
主要结局
Percentage of participants satisfied with usage of VALIDATE
时间窗: Up to sixteen weeks
At the end of the session, participants will be asked if 1. they enjoyed the process d 2. if they prefer this process versus completing a web or paper form and 3. would they recommend the process to others?
Concordance of data collection - identified relatives
时间窗: Up to sixteen weeks
Accuracy rates will be calculated by dividing the number of VALIDATE identified relatives by the number identified by a trained Clinician
Concordance of data collection - identified cancers
时间窗: Up to sixteen weeks
Accuracy rates will be calculated by dividing the number of VALIDATE identified cancers by the number identified by a trained Clinician
Number of VALIDATE subjects versus Control subjects identified for further cancer predisposition assessment.
时间窗: Up to sixteen weeks
次要结局
未报告次要终点
