- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03153618
VALIDATE: Virtual Agent Linked Intelligent Disease Assessment Tool Engine (VALIDATE)
Study Overview
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
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All adults above the age of 18
Exclusion Criteria:
Children under the age of 18
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Baldeep Singh, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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