Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)

NCT ID: NCT02544074

Last Updated: 2025-03-25

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2024-11-13

Brief Summary

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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.

Detailed Description

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Participants will be recruited based on their eSAGE scores and evaluated with neuropsychological testing and medical history to determine their status as normal, mild cognitive impairment, or dementia.

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:

Subjects will be scheduled for a one time visit where they will be administered both the tablet eSAGE and the smartphone eSAGE. eSAGE tablet scores will be compared to eSAGE smartphone scores to determine if the two formats are equivalent to each other.

Conditions

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Mild Cognitive Impairment Dementia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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eSAGE score of 10

Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 11

Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 12

Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 13

Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 14

Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 15

Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 16

Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 17

Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 18

Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 19

Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 20

Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 21

Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 22

Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 9

Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 8

Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 6

Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 7

Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 5

Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 4

Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 3

Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 2

Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.

neuropsychological testing

Intervention Type BEHAVIORAL

standard neuropsychological testing including brief standardized assessments

Smartphone eSAGE score of 13

Participants who score a 13 on the smartphone eSAGE. Interventions include neuropsychological testing.

eSAGE testing

Intervention Type BEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Smartphone eSAGE score of 14

Participants who score a 14 on the smartphone eSAGE. Interventions include neuropsychological testing.

eSAGE testing

Intervention Type BEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Smartphone eSAGE score of 15

Participants who score a 15 on the smartphone eSAGE. Interventions include neuropsychological testing.

eSAGE testing

Intervention Type BEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Smartphone eSAGE score of 16

Participants who score a 16 on the smartphone eSAGE. Interventions include neuropsychological testing.

eSAGE testing

Intervention Type BEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Smartphone eSAGE score of 17

Participants who score a 17 on the smartphone eSAGE. Interventions include neuropsychological testing.

eSAGE testing

Intervention Type BEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Smartphone eSAGE score of 18

Participants who score a 18 on the smartphone eSAGE. Interventions include neuropsychological testing.

eSAGE testing

Intervention Type BEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Smartphone eSAGE score of 19

Participants who score a 19 on the smartphone eSAGE. Interventions include neuropsychological testing.

eSAGE testing

Intervention Type BEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Smartphone eSAGE score of 20

Participants who score a 20 on the smartphone eSAGE. Interventions include neuropsychological testing.

eSAGE testing

Intervention Type BEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Smartphone eSAGE score of 21

Participants who score a 21 on the smartphone eSAGE. Interventions include neuropsychological testing.

eSAGE testing

Intervention Type BEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Smartphone eSAGE score of 22

Participants who score a 22 on the smartphone eSAGE. Interventions include neuropsychological testing.

eSAGE testing

Intervention Type BEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Interventions

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neuropsychological testing

standard neuropsychological testing including brief standardized assessments

Intervention Type BEHAVIORAL

eSAGE testing

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults over 49 years old of either gender
* Vision and hearing sufficient for compliance with tests

Exclusion Criteria

* Diagnosis by a physician of moderate or severe dementia
* Intellectual disability
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brain Test, Inc.

INDUSTRY

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Douglas Scharre

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas Scharre, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28655351 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2014H0039

Identifier Type: -

Identifier Source: org_study_id

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