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Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And Research

Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And Research

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07016178
Acronym
INCLUDE
Enrollment
3454
Registered
2025-06-11
Start date
2025-10-13
Completion date
2026-01-15
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Alzheimer's Disease (Incl Subtypes), Cognitive Decline, Dementia, Mild Cognitive Impairment (MCI)

Keywords

Brain Health Navigator, Passive Digital Marker (PDM), early detection, MCI, Alzheimer's disease

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.

Interventions

BEHAVIORALAcceptability and Feasibility of Twistle messaging for PDM+ patients

PC patients identified by the PDM as high risk for developing or having undetected MCI or ADRD will receive the patient-informed message developed in Aim 2. The patient-informed message will include instructions for completing validated questions about subjective memory concerns. In addition, interested patients will have the option to schedule a visit with the BHN, or enroll in research opportunities.

Sponsors

Indiana University
Lead SponsorOTHER
University of Southern California
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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; Patients with less than 2 years of available EHR data; individuals whose primary language is not English; and current diagnosis of ADRD or MCI; and current diagnosis of bipolar disorder or schizophrenia.

Design outcomes

Primary

MeasureTime frameDescription
Implementation of the PDM to identify at risk patients3 months post index visitImplement the PDM, using IUH EHR data, to identify primary care patients aged 65 or older who a have undetected MCI or ADRD or who are at risk. Measured by the number of patients identified as high-risk by the PDM.
2.1 Effectiveness of Patient-informed messaging3 months post index visitEvaluate the effectiveness of the patient-informed message using IUH's patient facing application, Twistle, in engaging PDM positive patients to complete a cognitive assessment with the BHN as measured by the percentage of patients who open the message.
2.2 Effectiveness of Patient-informed messaging3 months post index visitEvaluate the effectiveness of the patient-informed message using IUH's patient facing application, Twistle, in engaging PDM positive patients to complete a cognitive assessment with the BHN as measured by the percentage that engage with the message.
2.3 Effectiveness of Patient-informed messaging3 months post index visitEvaluate the effectiveness of the patient-informed message using IUH's patient facing application, Twistle, in engaging PDM positive patients to complete a cognitive assessment with the BHN as measured by the percentage of patients who answer the Subjective Cognitive Concerns questions.
2.4 Effectiveness of Patient-informed messaging3 months post index visitEvaluate the effectiveness of the patient-informed message using IUH's patient facing application, Twistle, in engaging PDM positive patients to complete a cognitive assessment with the BHN as measured by the percentage of patients who schedule a BHN appointment.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNicole Fowler, PhD

Indiana University School of Medicine, and Regenstrief Institute; IU Center for Aging Research

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026