Digital Detection of Dementia (D Cubed) Studies: D2

NCT05231954 | Completed Results DMC

• 2 other identifiers: 2008372812aR01AG069765-01
• Study Type: interventional
• Target: 5,325
• 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)

• 12-Month Cumulative Incidence of ADRD Diagnoses

  Any new ADRD case identified (documented in the EHR) within 12 months of the Annual Wellness Visit (index visit).

  12 months after index visit

Secondary Outcomes (1)

• 12-Month Cumulative Incidence of ADRD Services

  12 months after index visit

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)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Boustani MA, Ben Miled Z, Owora AH, Fowler NR, Dexter P, Puster E, Grout RW, Summanwar D, Erazo SF, Disla S, Coppedge K, Galvin JE. Digital Detection of Dementia in Primary Care: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2542222. doi: 10.1001/jamanetworkopen.2025.42222.

  PMID: 41212562 DERIVED

• Kleiman MJ, Plewes AD, Owora A, Grout RW, Dexter PR, Fowler NR, Galvin JE, Miled ZB, Boustani M. Digital detection of dementia (D3): a study protocol for a pragmatic cluster-randomized trial examining the application of patient-reported outcomes and passive clinical decision support systems. Trials. 2022 Oct 11;23(1):868. doi: 10.1186/s13063-022-06809-5.

  PMID: 36221141 DERIVED

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

Limitations and Caveats

We had a delay in releasing the second cohort of the PDM by about 3 months due to enabling an HL7 process. This made it possible for Epic to run a program to flag PDM and PDM+QDRS automatically. For the first cohort, we manually entered the data.

Results Point of Contact

• Title: Katrina Coppedge
• Organization: Indiana University

kcoppedg@iu.edu

317-278-1602

Study Officials

• Malaz Boustani, MD, MPH

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 28, 2022
• First Posted: February 9, 2022
• Study Start: July 5, 2022
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)