VALIDATE: Virtual Agent Linked Intelligent Disease Assessment Tool Engine (VALIDATE)

September 12, 2017 updated by: Stanford University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

All adults above the age of 18

Exclusion Criteria:

Children under the age of 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VALIDATE subjects
Will be invited to interact with VALIDATE to determine if they meet referral indications for cancer predisposition assessment.
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.
No Intervention: Control
Current standard of care will be followed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants satisfied with usage of VALIDATE
Time Frame: 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?
Up to sixteen weeks
Concordance of data collection - identified relatives
Time Frame: 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
Up to sixteen weeks
Concordance of data collection - identified cancers
Time Frame: 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
Up to sixteen weeks
Number of VALIDATE subjects versus Control subjects identified for further cancer predisposition assessment.
Time Frame: Up to sixteen weeks
Up to sixteen weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Baldeep Singh, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

November 30, 2017

Study Completion (Anticipated)

November 30, 2017

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 39175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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