Integrating eSAGE With EHR Data Using Machine Learning for the Early Detection and Monitoring of … (NCT06017505) | Clinical Trial Compass
By InvitationNot Applicable
Integrating eSAGE With EHR Data Using Machine Learning for the Early Detection and Monitoring of Cognitive Impairment in Individuals
United States1,486 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called eSAGE combined with electronic health record data and machine learning to detect cognitive impairment — can you explain what eSAGE actually involves for me as a participant, and how my personal health data would be used?
2Since this trial is 'enrolling by invitation only,' how would someone like me even be considered for it, and is it something you could refer me to if you thought it was appropriate?
3This study is measuring how accurately the tool can distinguish people with cognitive impairment from those who are cognitively normal — does that mean it's purely a detection and monitoring study, or could taking part lead to any changes in my actual care or treatment?
4Since this appears to be a diagnostic and monitoring technology study rather than a drug or procedure trial, what are the realistic risks or downsides I should think about — for example, around data privacy or the emotional impact of results?
5Given that this tool is still being evaluated for accuracy, would you recommend I also pursue standard cognitive assessments through your clinic, rather than waiting to see if this approach works?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Curve (AUC) for the ROC analysis in predicting subjects with cognitive impairment from cognitively normal subjects.