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

NCT05607732 · Northwestern University
In plain English

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About this study
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.
Eligibility criteria
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 design
Enrollment target: 45257 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-01-30
Estimated completion: 2027-07-07
Last updated: 2026-03-27
Interventions
Diagnostic Test: MyCog
Primary outcomes
  • Rate of detected impairment (3 years)
Sponsor
Northwestern University · other
With: Oak Street Health, University of Illinois at Chicago
Contacts & investigators
ContactMichael S Wolf, PhD MPH · contact · mswolf@northwestern.edu · 312-503-5592
ContactMorgan R Bonham, BS · contact · morgan.bonham@northwestern.edu · 312-503-1813
All locations (1)
Oak Street HealthRecruiting
Chicago, Illinois, United States
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial · TrialPath