跳至主要内容
临床试验/NCT03153618
NCT03153618撤回不适用

VALIDATE: Virtual Agent Linked Intelligent Disease Assessment Tool Engine

Stanford University0 个研究点开始时间: 2017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
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

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

Experimental

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

No Intervention

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

研究者

申办方类型
Other
责任方
Sponsor

相似试验