Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial

NCT05607732 | Recruiting DMC

• 1 other identifier: U01NS105562
• Study Type: interventional
• Target: 45,257
• Locations: 1 country
• Sites: 1

Brief Summary

Our study intends to offer 'real world' evidence of a viable, sustainable means to mobilize primary care via a comprehensive strategy for detecting cognitive impairment and dementias, advancing next steps for referral, and participating in the care planning and management of affected patients and caregivers. We will conduct a clinic-randomized, pragmatic trial testing the effectiveness and fidelity of our NIH Toolbox-derived paradigm to improve early detection and management of cognitive impairment/dementia in primary care settings serving health disparate patient populations.

Conditions

Alzheimer Disease; Dementia; Cognitive Impairment; Cognitive Decline

Keywords

Detect; Manage

Outcome Measures

Primary Outcomes (1)

• Rate of detected impairment

  This will be operationalized as either results of an administered cognitive test suggesting impairment ('detected') or having any relevant International Classification of Diseases (ICD) 10 code recorded in a patient's record after the trial launch date and throughout follow-up observation period ('diagnosis').

  3 years

Secondary Outcomes (3)

• Rate of detected cases with mild impairment

  3 years

• Rate of cognition-related referrals

  3 years

• Caregiver Involvement

  3 years

Study Arms (2)

MyCog Paradigm

EXPERIMENTAL

The MyCog paradigm establishes a protocol for implementing our self-administered assessment in the clinic whenever a patient or involved family member reports a concern. The MyCog test can be completed either in the exam room or the waiting room. The MyCog app, on an iPad, can be readily linked to the electronic health record, so once the two tests are completed, results are securely transmitted and will populate within discrete, fields that can be queried found in the patient record; specifically: 1) in a screening tab, under 'cognitive abilities', 2) a flow sheet to capture trend with future repeated tests - informing physicians of a patient's relative vs. normative cognitive decline. Both a binary, objective classification of 'impairment detected or suspected' or 'no impairment detected' will populate in the record, as well as a summary score to further guide the clinician by clarifying the extent to which a patient's performance falls outside a normal threshold.

Diagnostic Test: MyCog

Usual Care Arm

NO INTERVENTION

At Oak Street Health, cognitive assessments included when concerns are reported by patients or family members, if a clinician suspects a concern, or during Annual Wellness Visits (AWVs) are limited to the Mini-Cog©, and are variably administered, particularly outside of AWVs. Oak Street practices vary by clinician in terms of making referrals, how results are documented, what diagnosis code, placement in problem list or visit diagnosis, and any follow-up plans. While we will not make any explicit recommendations to usual care practices regarding their use of a cognitive assessment, we will ensure that 1) any chosen test is linked to a data field that can be queried in the EHR, and 2) providers receive a compiled list of local medical and non-medical referrals for any detected cases of CI. The Alzheimer's Association recommendations for early detection efforts among primary care practices will be provided to each clinical leadership.

Interventions

MyCog DIAGNOSTIC_TEST

MyCog uses well-validated, self-administered, iPad-based measures from the NIH Toolbox for the Assessment of Neurological Behavior and Function Cognition Battery to provide an efficient and sensitive cognitive screen that can be easily implemented in primary care. Preliminary data shows these tests can discriminate between cognitively normal older adults and those with CI (specifically mild cognitive impairment); enabling physicians to assess CI in ways currently not available.

MyCog Paradigm

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• been seen by an Oak Street healthcare provider affiliated with one of the 24 enrolled practices
• had at least one clinic visit (routine or Annual Wellness Visit) during the 3-year study period
• not been diagnosed previously with cognitive deficits, impairments or dementias.

You may not qualify if:

• Children, adolescence, and younger adults are excluded as cognitive impairment in these populations is often due to differences other than age-related changes.

Sponsors & Collaborators

• Northwestern University: lead
• Oak Street Health: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (1)

Oak Street Health

Chicago, Illinois, 60617, United States

RECRUITING

Related Publications (1)

• Lovett R, Bonham M, Yoshino Benavente J, Hosseinian Z, Byrne GJ, Varela Diaz M, Bass M, Yao L, Adin-Cristian A, Batio S, Kim M, Sluis A, Moran M, Buchanan DR, Hunt J, Young SR, Gershon R, Nowinski C, Wolf M. Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm. BMJ Open. 2023 Oct 18;13(10):e080101. doi: 10.1136/bmjopen-2023-080101.

  PMID: 37852774 DERIVED

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases

Central Study Contacts

Michael S Wolf, PhD MPH

CONTACT

312-503-5592; mswolf@northwestern.edu

Morgan R Bonham, BS

CONTACT

312-503-1813; morgan.bonham@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 7, 2022
• Study Start: January 30, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): July 7, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)