Primary Care Detection and Management of Cognitive Impairment Leveraging Mobile Digital Technologies: The MyCog Mobile Trial
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We will test the effectiveness + fidelity of a primary care strategy for the early detection / diagnosis / management of cognitive impairment, including dementia, that leverages mobile and in-clinic digital assessments linked to electronic health records. More than 7 million U.S. adults have Alzheimer’s disease (AD) or Alzheimer’s disease related dementias (ADRD). Early identification / diagnosis of AD/ADRD is a critical public health priority, as it benefits patients and families through earlier care partner involvement, improved treatment decision making and access, more opportunities for care coordination and planning, and sustained independence and quality of life. Yet an estimated half of AD/ADRD cases in the U.S. remain undetected, and 90% of Mild Cognitive Impairment (MCI) cases, often a prodrome to AD/ADRD, are missed or not diagnosed in a timely manner. Practical, scalable strategies are needed to better detect, diagnose and manage AD/ADRD, specifically in ‘frontline’ primary care settings that manage the health of most older adults. As members of our team previously developed the NIH Toolbox for Assessment of Neurological and Behavioral Function, we used this to validate a primary care paradigm for early AD/ADRD detection, known as MyCog (UH3NS105562). This includes a brief, iPad-based, self-administered, electronic health record (EHR)-linked strategy to assess for cognitive impairment (CI) during primary care visits as required with Medicare Annual Wellness Visits or when concerns are identified. ‘Turnkey’ recommendations also provide guidance in the EHR to assist care teams with addressing test results. Our learnings to date via two implementation studies (R01AG069762; U01NS105562) have revealed a need by primary care teams to have a mobile MyCog platform for patients to remotely complete cognitive testing prior to an in-person visit. Thus, we developed and validated MyCog Mobile (R01AG074245), a smartphone app version of MyCog tests that can be shared with patients via the patient portal and auto-populate results within the EHR. Our coordinated MyCog Mobile Strategy first invites patients to complete cognitive testing remotely via the MyCog Mobile app. Those that do not - or cannot adequately use the mobile app are given the in-person, clinic- based, iPad version. Our team now proposes to conduct a 2-arm, clinic-randomized, type 2 hybrid effectiveness- implementation trial to evaluate both the MyCog Mobile strategy’s effectiveness for the early detection of CI and AD/ADRD, and fidelity of its implementation. Primary care practices (N=20) will be randomized and followed for 18+ months. Our specific aims are to: 1) test the effectiveness of MyCog Mobile to improve early detection and diagnosis of CI and AD/ADRD in primary care settings compared to usual care, 2) evaluate its fidelity and identify patient, care partner, and care team barriers and facilitators to implementation, 3) assess for heterogeneity of treatment effects, 4) determine the costs of implementing MyCog Mobile from a primary care perspective.
