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

NCT04063371 | Completed Results

• 1 other identifier: NEW-33307
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• Number of Participants With a Diagnosis of a Cognitive Impairment Disorder Measured by Pharmacological Interventions for the Management of Cognitive Impairment.

  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.

  60 days

• Number of Participants in the Intervention and Control Groups With Any Referral for Further Evaluation/Management of Potential Cognitive Impairment

  Number of participants in the intervention and the two control groups with any referral for further evaluation/management of potential cognitive impairment.

  60 days

• Number of Participants in the Intervention and the Control Groups With at Least One Follow-up Visit for Additional Investigation of a Cognitive Impairment Disorder.

  Number of participants in the intervention and the two control groups with at least one follow-up visit for additional investigation of a cognitive impairment disorder.

  60 days

Secondary Outcomes (4)

• Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.

  60 days

• Number of Participants With Pharmacological Interventions for the Management of the Cognitive Impairment in the Subgroups of the Intervention Arm With and Without Additional Inputs From Informants

  60 days

• Scoring

  60 days

• Questionnaires

  60 days

Study Arms (3)

Control Group 1

At least one location will serve as the control office and will continue to conduct their visits including screening for cognitive impairment as they normally do using their usual method based on the primary care provider's normal practice.

Intervention Group

At least one different location will serve as the intervention office where all the providers, as their standard of care, use a standardized method for screening for cognitive impairment consisting of using the SAGE or eSAGE test and having a conversation with an individual who knows the patient well (if possible) to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.

Other: Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE); Other: Informant Conversation

Control Group 2

Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE.

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.

Intervention Group

Informant Conversation OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults 65-89 without a known diagnosis of cognitive impairment or dementia who complete a non-acute care office visit will be included in the trial.

You may qualify if:

• Adults 65-89 years of age who complete a non-acute care office visit.

You may not qualify if:

• Diagnosis of mild cognitive impairment or dementia in the medical records.
• Diagnosis of visual loss or conditions causing visual loss in the medical records unless it is clear that the loss would not be sufficient to preclude reading standard medical forms with or without the use of visual aids.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43221, United States

Location

Related Publications (1)

• Scharre DW, Vrettos NE, Nagaraja HN, Wexler RK, Clark AD, Nguyen CM. Self-administered gerocognitive examination (SAGE) aids early detection of cognitive impairment at primary care provider visits. Front Med (Lausanne). 2024 Jun 13;11:1353104. doi: 10.3389/fmed.2024.1353104. eCollection 2024.

  PMID: 38938387 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Douglas Scharre
• Organization: The Ohio State University

Doug.Scharre@osumc.edu

614-293-4969

Study Officials

• Douglas Scharre, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Clinical

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: October 14, 2019
• Primary Completion: April 6, 2020
• Study Completion: July 7, 2020
• Last Updated: May 14, 2024
• Results First Posted: July 19, 2021

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)