Digital Screening Tools for Dementia
(Dcubed Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMalaz Boustani, MD, MPH

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Malaz Boustani, MD, MPH

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for individuals aged 65 or older who have visited a primary care practice in the past year, can consent to participate, and communicate in English or Spanish. They must have electronic health records from at least the last three years. Those with prior dementia diagnoses, certain medication histories, or serious mental illnesses are excluded.

Inclusion Criteria

At least one visit to primary care practice within the past year

I can communicate in English or Spanish.

I am 65 years old or older.

See 2 more

Exclusion Criteria

I have been prescribed medications for memory problems before.

Permanent resident of a nursing facility

You have been diagnosed with serious mental illnesses like bipolar disorder or schizophrenia.

See 1 more

Treatment Details

Interventions

Passive Digital Marker for screening for ADRD (Diagnostic Test)

Trial OverviewThe study is testing a Passive Digital Marker (PDM) and Quick Dementia Rating System (QDRS), alone and combined, to see if they help detect Alzheimer's Disease and Related Dementias (ADRD) more effectively during routine primary care visits.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Passive Digital Marker (PDM)Experimental Treatment1 Intervention

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.

Group II: Annual Well Visit or any other visit to Primary Care DoctorActive Control1 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.

Group III: Passive Digital Marker (PDM) + Quick Dementia Rating Scale (QDRS)Active Control1 Intervention

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.