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

NCT ID: NCT07016178

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2026-01-15

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

PDM+

Patients at participating clinics identified through the Passive Digital Marker (PDM) as at risk will be contacted for clinical follow up via Twistle, a secure text message platform prior to their next schedule primary care visit. Patients identified as at risk, PDM+, who confirm a cognitive concern via Twistle will be referred to the IU Health Brain Health Navigator (BHN), a clinical nurse embedded in primary care. . The BHN will deliver the IUH Brain Health Protocol to assess for reversible causes, initiate shared decision-making processes for care and treatment, assess for treatment eligibility, and complete a warm hand-off when appropriate. Additionally, the BHN will facilitate patient enrollment in the Indiana CTSI ALL IN research registry and/or the IU Biobank.

Group Type: EXPERIMENTAL

Acceptability and Feasibility of Twistle messaging for PDM+ patients

Intervention Type: 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.

Interventions

Acceptability 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

University of Southern California

OTHER

Sponsor Role: collaborator

Responsible Party

Nicole R. Fowler, PhD

Scientist, Indiana University Center for Aging Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicole Fowler, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

IU Health Primary Care

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

25818

Identifier Type: -

Identifier Source: org_study_id