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NCT04063371 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Ohio State University.

Completed
Registry status
300
Enrollment target

NCT04063371: Completed study, sponsored by Ohio State University.

NCT04063371 is a clinical trial that has completed, run by Ohio State University. The registered enrollment target is 300 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04063371 has completed, sponsored by Ohio State University.

COMPLETED
Registry status
300 participants
Enrollment target

Study 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.

Primary Outcome

Number of participants in the intervention and the two control groups with diagnosis of a cognitive impairment disorder as measured by pharmacological interventions for the management of cognitive impairment.

Interventions

  • OTHER Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE)
  • OTHER Informant Conversation

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2019-10-14
Est. Completion 2020-07-07
Ohio State University

552 total trials

What the finished NCT04063371 record still lists

NCT04063371 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 2 interventions - of which Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE) is the first listed.

NCT04063371 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04063371 about?

NCT04063371 is a clinical study titled "SAGE for the Early Detection of Cognitive Impairment at Primary Care Provider Visits". 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...

What is the current status of trial NCT04063371?

This trial is currently completed. The enrollment target is 300 participants. The study started on 2019-10-14. Estimated completion is 2020-07-07.

What interventions are being tested in trial NCT04063371?

The interventions under investigation include: Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE) (OTHER), Informant Conversation (OTHER).

Who is sponsoring clinical trial NCT04063371?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04063371, the US trial registry maintained by the National Library of Medicine. NCT04063371 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.