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MyCog for Cognitive Impairment

N/A

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to provide real-world evidence on a sustainable method to identify and manage cognitive impairment and dementias in primary care settings. The study will test a new approach derived from the NIH Toolbox to

Who is the study for?

The MyCog trial is for individuals who have visited an Oak Street healthcare provider at one of the 24 participating practices, had a clinic visit in the last 3 years, and have not been previously diagnosed with cognitive deficits or dementias.

What is being tested?

This study tests a new approach using health technologies to detect early signs of cognitive impairment and dementia in primary care settings. It's a practical trial that randomly assigns clinics to use this NIH Toolbox-derived method.

What are the potential side effects?

Since MyCog is focused on detection rather than treatment, it does not involve medications; therefore, traditional side effects are not applicable. However, there may be psychological impacts from learning about cognitive impairments.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not a child, adolescent, or young adult excluded due to cognitive reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of detected impairment

Secondary study objectives

Caregiver Involvement

Rate of cognition-related referrals

Rate of detected cases with mild impairment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MyCog ParadigmExperimental Treatment1 Intervention

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.

Group II: Usual Care ArmActive Control1 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.

0 / 1Eligibility criteria met