Digital Detection of Dementia (D Cubed) Studies: D3

NCT06224205 | Recruiting DMC

• 2 other identifiers: 2008372812bR01AG069765-01
• Study Type: interventional
• Target: 3,150
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of the pragmatic trial is to evaluate the practical utility and effect of the PDM, the QDRS, and the combined approach (PDM + QDRS) in improving the annual rate of new documented ADRD diagnosis in primary care practices.

Conditions

Alzheimer Disease and Related Dementias (ADRD)

Outcome Measures

Primary Outcomes (1)

• Incidence of ADRD

  The primary outcome measure will be any new ADRD case identified (documented in the EHR) within 12 months of the Annual Wellness Visit (index visit).

  12 months

Secondary Outcomes (1)

• Incidence of ADRD services

  12 months after index date

Study Arms (3)

Annual Well Visit or any other visit to Primary Care Doctor

NO INTERVENTION

Annual Well Visit or any other visit to Primary Care Doctor: This is the usual care arm. Electronic Health Record Data for patients from the clinics randomized to usual care will be collected for comparison with the other 2 arms. Patients from these primary care clinics must have had a visit to their doctor either as an annual well visit (AWV) or any other type of visit. These clinics will not have to do anything for the study but run their business as usual without altering anything.

Passive Digital Marker (PDM)

EXPERIMENTAL

Passive Digital Marker (PDM): Electronic Health Record Data from those clinics randomized to PDM will be run through the PDM, a machine learning algorithm which can predict ADRD one year and three years prior to its onset.

Other: Passive Digital Marker for screening for ADRD

Passive Digital Marker (PDM) + Quick Dementia Rating Scale (QDRS)

ACTIVE COMPARATOR

Patients in the primary care clinics randomized to PDM+QDRS will have Electronic Health Record Data of their patients run through the PDM, a machine learning algorithm which can predict ADRD one year and three years prior to its onset. In addition, patients from these clinics will have their patients complete the QDRS, a validated patient reported outcome (PRO) tool. This combined approach will assess the value of early detection of ADRD and if the annual well visit can overcome the barriers related to early detection of ADRD.

Other: Passive Digital Marker for screening for ADRD

Interventions

Passive Digital Marker for screening for ADRD OTHER

Patients in the primary care clinics randomized to PDM+QDRS will have Electronic Health Record Data of their patients run through the PDM, a machine learning algorithm which can predict ADRD one year and three years prior to its onset. In addition, patients from these clinics will have their patients complete the QDRS, a validated patient reported outcome (PRO) tool. This combined approach will assess the value of early detection of ADRD and if the annual well visit can overcome the barriers related to early detection of ADRD.

Also known as: Patient reported outcome (QDRS) for screening for ADRD

Passive Digital Marker (PDM); Passive Digital Marker (PDM) + Quick Dementia Rating Scale (QDRS)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years or older
• At least one visit to primary care practice within the past year
• Ability to provide informed consent
• Ability to communicate in English or Spanish
• Available EHR data from at least the past three years

You may not qualify if:

• Prior ADRD or mild cognitive impairment diagnosis as determined by ICD-10 code
• Evidence of any history of prescription for a cholinesterase inhibitors or memantine.
• Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
• Permanent resident of a nursing facility

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Miami School of Medicine

Boca Raton, Florida, 33431 -6437, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Mass Screening; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Health Care Surveys; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Health Services Administration

Study Officials

• Malaz Boustani, MD, MPH

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malaz Boustani, MD, MPH

CONTACT

317-274-8536; mboustan@iu.edu

Katrina Coppedge, BA

CONTACT

317-278-1602; kcoppedg@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Aging Research

Model Details: This is a pragmatic cluster randomized control trial with randomizing clinic and with wavier of consent for human subjects. The data collection is from the EHR. There is no research data collection outside the EHR.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: November 8, 2023
• Primary Completion: November 8, 2025
• Study Completion: November 8, 2025
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)