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SAGE for the Early Detection of Cognitive Impairment at Primary Care Provider Visits

NCT04063371 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-05-14

Study results available
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Summary

Thus far no large randomized trial has demonstrated a correlation between screening and improved outcomes. This would need to be done to gain widespread acceptance of screening and case finding programs. Early detection of cognitive impairment could potentially result in the appropriate treatment of reversible cognitive impairment conditions or earlier initiation of pharmacological interventions for the management of a variety of other dementia or Mild Cognitive Impairment (MCI) conditions. A screening approach that reduces the number of false positive screens would improve the comfort level of physicians and patients with cognitive screening programs.

The investigators propose to use the Self-Administered Gerocognitive Examination (SAGE) and the Electronic Self-Administered Gerocognitive Examination (eSAGE) to identify patients who score in the cognitive impairment range during an office visit with their primary care provider. Conversation with an individual who knows the patient well (if possible) will be performed to ascertain a significant change in the patient's cognitive skills over the previous year. The investigators wish to determine if screening for cognitive impairment in this way leads to new diagnoses and management outcomes compared to a group of primary care providers who use their current usual method in screening for cognitive impairment during office visits.

Conditions

Interventions

OTHER

Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE)

The Self-Administered Gerocognitive Examination (SAGE) is a reliable and valid assessment that is used to detect MCI and early dementia. It is a pen and paper assessment that has 4 interchangeable versions. The digital version of SAGE (eSAGE; commercially known as BrainTest®) is made for tablet use, consists of the identical test questions as SAGE, and is strongly associated with the validated SAGE.

OTHER

Informant Conversation

If possible, the provider will have a conversation with an individual who knows the patient will to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Douglas Scharre, MD · Ohio State University

Eligibility

Min Age
65 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2020-04-06
Completion
2020-07-07

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063371 on ClinicalTrials.gov