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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607732
• Other study ID #: U01NS105562
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: July 7, 2027

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: Michael S Wolf, PhD MPH
• Phone: 312-503-5592
• Email: mswolf[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45257
• Est. completion date: July 7, 2027
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Oak Street Health	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Oak Street Health, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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