VALIDATE: Virtual Agent Linked Intelligent Disease Assessment Tool Engine

Cancer Clinical Trial

— VALIDATE  

Official title:

VALIDATE: Virtual Agent Linked Intelligent Disease Assessment Tool Engine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03153618
• Other study ID #: 39175
• Status: Withdrawn
• Phase: N/A
• First received: May 11, 2017
• Last updated: September 12, 2017
• Start date: September 1, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: September 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All adults above the age of 18

Exclusion Criteria:

Children under the age of 18

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• VALIDATE system
Will be invited to interact with VALIDATE to answer questions about Family Cancer history and some personal medical and lifestyle history. Based on responses, VALIDATE will determine if they meet referral indications for cancer predisposition assessment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants satisfied with usage of VALIDATE	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?	Up to sixteen weeks
Primary	Concordance of data collection - identified relatives	Accuracy rates will be calculated by dividing the number of VALIDATE identified relatives by the number identified by a trained Clinician	Up to sixteen weeks
Primary	Concordance of data collection - identified cancers	Accuracy rates will be calculated by dividing the number of VALIDATE identified cancers by the number identified by a trained Clinician	Up to sixteen weeks
Primary	Number of VALIDATE subjects versus Control subjects identified for further cancer predisposition assessment.		Up to sixteen weeks