Skip to main content
OpenTrials
Completed

NCT Number: NCT07016178

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Cognitive Impairment (MCI) Alzheimer Disease Alzheimer's Disease (Incl Subtypes) Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Primary Care

Indianapolis, Indiana, 46201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 not English; and current diagnosis of ADRD or MCI; and current diagnosis of bipolar disorder or schizophrenia.

Treatment and study plan

Acceptability and Feasibility of Twistle messaging for PDM+ patients

Behavioral

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.

Primary outcomes

  1. Implementation of the PDM to identify at risk patients

    Time frame: 3 months post index visit

    Implement 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. 2.1 Effectiveness of Patient-informed messaging

    Time frame: 3 months post index visit

    Evaluate 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.

  3. 2.2 Effectiveness of Patient-informed messaging

    Time frame: 3 months post index visit

    Evaluate 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.

  4. 2.3 Effectiveness of Patient-informed messaging

    Time frame: 3 months post index visit

    Evaluate 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.

  5. 2.4 Effectiveness of Patient-informed messaging

    Time frame: 3 months post index visit

    Evaluate 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.

Secondary outcomes

  1. Engage in clinical research

    Time frame: 3 months post index visit

    The BHN will refer patients to participate in ADRD clinical trials and will provide them information for the IU clinical research registry. Measured by the percentage of patients who consent to the IU CTSI All IN clinical research registry and/or the IU Biobank repository.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • University of Southern California

Registry information

Acronym: INCLUDE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.