CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04063371
NCT04063371N/ACompleted

Self-Administered Gerocognitive Examination (SAGE) for the Early Detection of Cognitive Impairment at Primary Care Provider Visits

Ohio State University·observational·Posted Aug 21, 2019·Updated May 14, 2024

In Brief

An observational study evaluating Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE) and Informant Conversation for Cognitive Impairment. Completed, enrolled 300 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 21, 2019
Enrollment StartOct 14, 2019
Primary CompletionApr 6, 2020
Study CompletionJul 7, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.9 years ago

Interventions

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

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.

Informant Conversationother

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.