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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Dementia; Alzheimer Disease; Cognitive Decline
• Intervention / Treatment: Diagnostic test: MyCog

Detailed Description

Practical, scalable strategies are needed to help primary care practices better detect and manage cognitive impairment (CI), especially those caring for medically underserved, low socioeconomic status (SES) communities. Since 2017, our team has been a member of the Consortium for Detecting Cognitive Impairment, Including Dementia (DetectCID); a network dedicated to improving clinical paradigms for early detection of CI and Alzheimer's disease-related dementias (ADRD) and its subsequent management in everyday clinical settings. Having developed the NIH Toolbox for Assessment of Neurological and Behavioral Function and with expertise in health system re-design for patient-centered care, we validated our clinical paradigm, known as MyCog. This includes a brief, iPad-based, self-administered, electronic health record (EHR)-linked strategy to assess for CI during primary care visits when concerns are identified, and 'turnkey' recommendations to address them.

We will partner with a national primary care provider (Oak Street Health) and conduct a 2-arm, clinic-randomized, 'real world' pragmatic trial comparing MyCog to usual care. We will focus on populations experiencing CI/ADRD disparities: Black, H/L, and low SES older adults.

Our specific aims and hypotheses (H) are to:

Aim 1: Test the effectiveness of the MyCog paradigm to improve early detection of cognitive impairment and dementias among low SES, Black and Hispanic/Latino older adults.

Compared to usual care, primary care practices implementing MyCog will demonstrate:

H1: higher rates of detected and/or diagnosed cases of cognitive decline and impairment

Among detected and/or diagnosed cases of cognitive impairment, primary care practices implementing MyCog - compared to usual care - will have:

H2: a greater proportion of early stage (mild) cognitive impairments H3: more referrals for related medical and non-medical services H4: greater caregiver involvement in subsequent patient visits

Aim 2: Investigate the presence of disparities in early detection of cognitive impairment, its diagnosis, and rate of referrals by race and ethnicity.

H5: Disparities in early detection of CI, diagnosis, and referrals by race and ethnicity will be reduced among those primary care practices implementing MyCog compared to usual care.

Aim 3: Determine the fidelity and reliability of MyCog and identify any patient, caregiver, clinician, and/or health system barriers to its optimal, sustained implementation.

Aim 4: Assess the cost-effectiveness of the MyCog paradigm from a primary care perspective.

• Study Type: Interventional
• Enrollment (Estimated): 45257
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael S Wolf, PhD MPH; Phone Number: 312-503-5592; Email: mswolf@northwestern.edu
• Study Contact Backup: Name: Morgan R Bonham, BS; Phone Number: 312-503-1813; Email: morgan.bonham@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60617
      • Recruiting
      • Oak Street Health
      • Contact: Justin Hunt, MD; Email: justin.hunt@oakstreethealth.com
      • Contact: Maggie Moran, MPH; Email: maggie.moran@oakstreethealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MyCog Paradigm; 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; 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.
No Intervention: Usual Care Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of detected cases with mild impairment	Mild vs. other impairment rates will be compared across trial arms, operationalized by ICD code groupings.	3 years
Rate of cognition-related referrals	Extraction from the electronic data warehouse for whether or not a cognitive-related referral was made (medical or non-medical) following a "detected" cognitive screen	3 years
Caregiver Involvement	Text search of clinic note from any follow-up visit post AWV, wellness visit mention of accompanying family member/caregiver; extraction from Enterprise Data Warehouse to determine if proxy access to patient's MyChart portal has been shared.	3 years

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of Illinois at Chicago; Oak Street Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): July 7, 2027

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Detect; Manage
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease; Dementia
• Other Study ID Numbers: U01NS105562 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No