Integrating eSAGE With EHR Data Using Machine Learning for the Early Detection and Monitoring of Cognitive Impairment in Individuals

Sponsor
Douglas Scharre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06017505
Collaborator
(none)
1,486
1
24
61.9

Study Details

Study Description

Brief Summary

The goal of this observational trial is to leverage the electronic Self-Administered Gerocognitive Examination (eSAGE), a variety of metadata (a set of data that describes and gives information about other data) collected during eSAGE testing, electronic health records (EHR) information, and advanced machine learning (ML) techniques to develop a new tool that can aid in early-stage prediction of individuals with cognitive impairments.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: electronic self administered gerocognitive examination (eSAGE)

Detailed Description

This is a retrospective and prospective record review trial for patients who are followed at the Center for Cognitive and Memory Disorders.

eSAGE assessment data (including cognitive data, behavioral data, timing data and other metadata) as well as varying amount of electronic health records (EHR) data will be collected on all eligible subjects. Machine learning techniques with feature selection will identify important EHR variables to determine what may be useful for the prediction of cognitive impairment.

Based on the EHR analysis additional questions will be added to the eSAGE to make an enhanced eSAGE version (eSAGE+). The goal of the eSAGE+ is to facilitate the identification of cognition impairment, and ultimately have a translational impact on Alzheimer's disease (AD) identification and management.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1486 participants
Observational Model:
Case-Only
Time Perspective:
Other
Official Title:
Integrating the Electronic Self-administered Gerocognitive Examination (eSAGE) With Electronic Health Records (EHR) Data Using Machine Learning (ML) for the Early Detection and Monitoring of Cognitive Impairment in Individuals
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Subject population

Males and females 50 years of age and over who complete the eSAGE as part of their office visit at the Center for Cognitive and Memory Disorders.

Diagnostic Test: electronic self administered gerocognitive examination (eSAGE)
A self-administered digital assessment that evaluates multiple cognitive domains: orientation, language, memory, executive function, calculations, abstraction, and visuospatial abilities, through multiple questions. Additionally, it includes the collection of six clinical variables: education, gender, race, family history of dementia, stroke, and emotion.

Outcome Measures

Primary Outcome Measures

  1. Area Under the Curve (AUC) for the ROC analysis in predicting subjects with cognitive impairment from cognitively normal subjects. [1 day visit]

    AUC ranges in value from 0 to 1

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Males and females 50 years of age and over who complete the eSAGE as part of their office visit at the Center for Cognitive and Memory Disorders.
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nicole Vrettos Columbus Ohio United States 43123

Sponsors and Collaborators

  • Douglas Scharre

Investigators

  • Principal Investigator: Douglas Scharre, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Douglas Scharre, Professor-Clinical, Ohio State University
ClinicalTrials.gov Identifier:
NCT06017505
Other Study ID Numbers:
  • 2023H0249
First Posted:
Aug 30, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2023