Clinical trial NCT02544074: Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)
Official title: Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Dementia
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Brain Test, Inc.
First posted: 2015-09-09
Enrollment: 69
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Addendum:

Subjects will be recruited from community events and our clinic and research center.

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.

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: 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.

Eligibility 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

Primary outcomes:
measure: eSAGE Score Compared to the Sum of the Neuropsychological Measures.
timeFrame: 3 Hours
Secondary outcomes:
measure: eSAGE Score Compared to the Paper SAGE Score
timeFrame: 3 hours
measure: eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score
timeFrame: 3 hours
measure: eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score
timeFrame: 3 hours
measure: eSAGE Score Compared to the Boston Naming Test Score
timeFrame: 3 hours
measure: eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score
timeFrame: 3 hours
measure: eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score
timeFrame: 3 hours
measure: eSAGE Score Compare to the FAS Verbal Fluency Task Score
timeFrame: 3 hours
measure: eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score
timeFrame: 3 hours
measure: eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score
timeFrame: 3 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Douglas Scharre, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.