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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of detected impairment
Secondary outcome measures
Caregiver Involvement
Rate of cognition-related referrals
Rate of detected cases with mild impairment
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.
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Who is running the clinical trial?
Oak Street HealthUNKNOWN
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
871,830 Total Patients Enrolled
University of Illinois at ChicagoOTHER
609 Previous Clinical Trials
1,514,052 Total Patients Enrolled
3 Trials studying Cognitive Decline
375 Patients Enrolled for Cognitive Decline
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently being enrolled in this ongoing medical study?
"As per information on clinicaltrials.gov, this trial is actively seeking volunteers. The study was first listed on 1/30/2024 and the most recent update was on 2/6/2024."
Answered by AI
What is the current number of individuals receiving treatment within this specific clinical trial?
"Yes, the details on clinicaltrials.gov affirm that this research project is currently seeking suitable participants. The trial was initially publicized on January 30th, 2024 and last revised on February 6th, 2024. A total of 45,257 individuals are sought from a single site for enrollment in this study."
Answered by AI
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