Digital Detection of Dementia (D Cubed) Studies: D3

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
Indiana University
Study ID
NCT06224205
Status
Recruiting
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Conditions

  • Alzheimer Disease and Related Dementias (ADRD)

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 8, 2023
Status verified
Oct 2025
Primary completion
Nov 8, 2025
Completion
Nov 8, 2025

Study Design

Enrollment
3,150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • No Intervention: Annual Well Visit or any other visit to Primary Care Doctor
    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.
  • Experimental: Passive Digital Marker (PDM)
    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.
  • Active Comparator: Passive Digital Marker (PDM) + Quick Dementia Rating Scale (QDRS)
    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.

Primary Outcome Measure

Incidence of ADRD [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami School of MedicineBoca RatonFlorida33431 -6437
James Galvin, MD

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By research site
University of Miami School of Medicine· Boca Raton, FL

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