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Trial record 1 of 1 for:    NCT02544074
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Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE) (eSAGE)

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ClinicalTrials.gov Identifier: NCT02544074
Recruitment Status : Completed
First Posted : September 9, 2015
Results First Posted : November 6, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Brain Test, Inc.
Information provided by (Responsible Party):
Douglas Scharre, Ohio State University

Brief Summary:

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.


Condition or disease Intervention/treatment
Mild Cognitive Impairment Dementia Behavioral: neuropsychological testing

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)
Study Start Date : January 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
eSAGE score of 10
Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 11
Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 12
Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 13
Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 14
Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 15
Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 16
Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 17
Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 18
Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 19
Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 20
Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 21
Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 22
Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 9
Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 8
Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 6
Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 7
Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 5
Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 4
Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 3
Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments

eSAGE score of 2
Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
standard neuropsychological testing including brief standardized assessments




Primary Outcome Measures :
  1. eSAGE Score Compared to the Sum of the Neuropsychological Measures. [ Time Frame: 3 Hours ]

    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.



Secondary Outcome Measures :
  1. eSAGE Score Compared to the Paper SAGE Score [ Time Frame: 3 hours ]
    The investigators will compare the subject's scores on the SAGE in digital format to their paper SAGE scores to determine if these two formats are equivalent to each other. Associations will be investigated using Spearman correlations.

  2. eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score [ Time Frame: 3 hours ]
    The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.

  3. eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score [ Time Frame: 3 hours ]
    The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.

  4. eSAGE Score Compared to the Boston Naming Test Score [ Time Frame: 3 hours ]
    The investigators will compare the eSAGE scores to the Boston Naming Test score. The Boston Naming Test consists of 60 pictures of nouns that subjects must try to name. Associations will be investigated using Spearman correlations.

  5. eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score [ Time Frame: 3 hours ]
    The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.

  6. eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score [ Time Frame: 3 hours ]
    The investigators will compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) total learning scores. Associations will be investigated using Spearman correlations. The investigators will also compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) delayed recall scores. Associations will be investigated using Spearman correlations.

  7. eSAGE Score Compare to the FAS Verbal Fluency Task Score [ Time Frame: 3 hours ]
    The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.

  8. eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score [ Time Frame: 3 hours ]
    The investigators will compare the eSAGE scores to the WAIS III Letter-number scores. The WAIS III Letter-number test asks subjects to recall a series of numbers in increasing order and letters in alphabetical order. Associations will be investigated using Spearman correlations.

  9. eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score [ Time Frame: 3 hours ]
    The investigators will compare the eSAGE scores to the WAIS III Block Design scores. The WAIS III Block Design requires the replication of red and white designs using three-dimensional colored blocks. Associations will be investigated using Spearman correlations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544074


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Douglas Scharre
Brain Test, Inc.
Investigators
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Principal Investigator: Douglas Scharre, M.D. Ohio State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Douglas Scharre, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02544074    
Other Study ID Numbers: 2014H0039
First Posted: September 9, 2015    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: March 20, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders
Cognition Disorders