Clinical trial NCT07016178: Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And Research
Official title: Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And Research
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Alzheimer Disease
Alzheimer's Disease (Incl Subtypes)
Dementia
Cognitive Decline
Keywords: Brain Health Navigator
Passive Digital Marker (PDM)
early detection
MCI
Alzheimer's disease
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2025-06-11
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Recent studies have highlighted the potential use of electronic health record (EHR) data for scalable and less biased identification of people who may have or be at risk of developing MCI or ADRD at the population level.8,9 Using data from the EHR in advance of PC visits can systematically identify patients with undetected MCI and ADRD. At Indiana University (IU), researchers developed a Passive Digital Marker (PDM) to enable early detection of ADRD with an 80% accuracy for one-year and three-year prediction horizons.8,9 Despite the accuracy of the PDM, the feasibility, acceptability, and overall effectiveness of its use for early detection of ADRD in PC remains unclear.

Building on this innovative tool and the ongoing engagement in IUH PC for early detection of ADRD, we propose a project to test the acceptability and feasibility of implementing the PDM in IUH PC to identify people with and at risk of MCI and ADRD and measure if we can increase patient engagement in research and evidence-based follow-up care with the IUH Brain Health Navigator (BHN). The BHN, is primary care based registered nurse with special training to conduct additional assessments of patients following a positive ADRD screen to identify possible underlying causes of cognitive impairment and assist the PCP to facilitate the patient's next steps for diagnostic assessment.


Eligibility criteria: Inclusion Criteria:

* 65 years and older; established patients of 12 selected clinics at IU Health PC who are identified by the PDM as high risk for developing or having undetected MCI or ADRD.

Exclusion Criteria:

* Patients younger than 65 years; new patients to IUH (less than 12 months); individuals whose primary language is neither English nor Spanish; and current diagnosis of ADRD or MCI.

Primary outcomes:
measure: Implementation of the PDM to identify at risk patients
timeFrame: 3 months post index visit
measure: 2.1 Effectiveness of Patient-informed messaging
timeFrame: 3 months post index visit
measure: 2.2 Effectiveness of Patient-informed messaging
timeFrame: 3 months post index visit
measure: 2.3 Effectiveness of Patient-informed messaging
timeFrame: 3 months post index visit
measure: 2.4 Effectiveness of Patient-informed messaging
timeFrame: 3 months post index visit
Secondary outcomes:
measure: Engage in clinical research
timeFrame: 3 months post index visit
Other outcomes:
Locations:
Study officials:
References: