NCT02544074|CompletedResults
Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)
eSAGE
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eSAGE
Sponsor study identifier
observational
69
1 country
1
Study Start
January 2015
Actual (reported)Primary Completion
November 13, 2024
Actual (reported)Study Completion
November 13, 2024
Actual (reported)The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia. SAGE's self-administered feature, pen and paper format, and four equivalent interchangeable forms allows it to be given in almost any setting, does not require any staff time to administer and makes it practical to rapidly screen large numbers of individuals in the community or in their home.This trial is being conducted to study the validity of SAGE in a digital format (eSAGE) for cognitive screening. The investigators will analyze the data to learn the correlations between eSAGE and gold standard neuropsychological testing designed to differentiate normal cognition from MCI and early dementia. The investigators will also find out whether the paper (SAGE) and electronic (eSAGE) versions of SAGE could be used interchangeably or not. Addendum: The eSAGE was previously validated in an earlier stage of this trial. It was initially designed for tablet use and the exact same test has recently been formatted for smartphone use. This addendum is being conducted to study the validity of the smartphone eSAGE compared to the tablet eSAGE for cognitive screening.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 13, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Actual (reported)March 18, 2015
Actual (reported)September 9, 2015
Actual (reported)November 6, 2017
Actual (reported)November 13, 2024
Actual (reported)November 13, 2024
Actual (reported)eSAGE Score Compared to the Sum of the Neuropsychological Measures.
Analysis will consist of comparing the subject's scores on the SAGE in digital format to their neuropsychological test scores. This will be a composite score of the neuropsychological testing scores. The neuropsychological measures include: * Boston Naming Test * Wisconsin Card Sort Task (WCST) * Hopkins Verbal Learning Test (HVLT) * FAS verbal fluency task * Wechsler Adult Intelligence Scale III (WAIS III) Letter-number and block design subtests Associations will be investigated using Spearman correlations.
3 Hours
eSAGE Score Compared to the Paper SAGE Score
3 hours
eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score
3 hours
eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score
3 hours
eSAGE Score Compared to the Boston Naming Test Score
3 hours
eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score
3 hours
Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.
Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.
standard neuropsychological testing including brief standardized assessments
Subjects will be recruited from a wide variety of community events including senior centers, health fairs, educational talks to lay public, independent and assisted living facilities, and free memory screens as well as from ambulatory Geriatric or Memory Disorders Clinics. The SAGE cognitive screening tool will be given to all subjects willing to take the test.Participants who complete the SAGE test and meet inclusion and exclusion criteria will be divided into groups based on their initial SAGE scores. Each group will be composed of subjects with the same score. Individuals will be randomly selected from each group and asked to further participate in a one-time clinical evaluation. Addendum: Subjects will be recruited from community events and our clinic and research center.
The Ohio State University
Columbus, Ohio, 43221, United States
Scharre DW, Chang SI, Nagaraja HN, Vrettos NE, Bornstein RA. Digitally translated Self-Administered Gerocognitive Examination (eSAGE): relationship with its validated paper version, neuropsychological evaluations, and clinical assessments. Alzheimers Res Ther. 2017 Jun 27;9(1):44. doi: 10.1186/s13195-017-0269-3.
The majority of the subjects were Caucasian and highly educated. Results may be limited based on where the patients were recruited and their range of cognitive abilities. The ADCS-ADL scale was used as self-report in subjects without a study partner.
Douglas Scharre, M.D.
Ohio State University
69 participants (actual enrollment reported by the registry).
First Submitted
March 18, 2015
First Posted
September 9, 2015
Study Start
January 2015
Actual (reported)Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.
Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.
Participants who score a 13 on the smartphone eSAGE. Interventions include neuropsychological testing.
Participants who score a 14 on the smartphone eSAGE. Interventions include neuropsychological testing.
Participants who score a 15 on the smartphone eSAGE. Interventions include neuropsychological testing.
Participants who score a 16 on the smartphone eSAGE. Interventions include neuropsychological testing.
Participants who score a 17 on the smartphone eSAGE. Interventions include neuropsychological testing.
Participants who score a 18 on the smartphone eSAGE. Interventions include neuropsychological testing.
Participants who score a 19 on the smartphone eSAGE. Interventions include neuropsychological testing.
Participants who score a 20 on the smartphone eSAGE. Interventions include neuropsychological testing.
Participants who score a 21 on the smartphone eSAGE. Interventions include neuropsychological testing.
Participants who score a 22 on the smartphone eSAGE. Interventions include neuropsychological testing.
Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 13, 2024
Actual (reported)Study Completion
November 13, 2024
Actual (reported)Last Updated
March 25, 2025
Results First Posted
November 6, 2017
Record last verified: 2025-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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