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Behavioural Intervention

Passive Digital Marker (PDM) for Caregiver

N/A

Recruiting

Led By Malaz Boustani, MD, MPH

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

65 years or older

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is looking at how effective different approaches are in improving the diagnosis rate of Alzheimer's disease and related dementias in primary care practices. They will be evaluating the use of the PDM,

Who is the study for?

This trial is for caregivers of individuals with Alzheimer's Disease or dementia. It aims to test if using a Passive Digital Marker (PDM) and the Quick Dementia Rating System (QDRS), either alone or combined, can help primary care practices diagnose dementia more frequently within a year.Check my eligibility

What is being tested?

The study is testing the effectiveness of a Passive Digital Marker tool and the QDRS in detecting Alzheimer's Disease and related dementias. The goal is to see if these methods increase diagnosis rates when used by primary care doctors.See study design

What are the potential side effects?

Since this trial involves digital tools for screening rather than medications, there are no direct physical side effects expected from participating in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 65 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of ADRD

Secondary outcome measures

Incidence of ADRD services

Trial Design

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: 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.

Group III: 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

978,612 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,017,735 Total Patients Enrolled

Malaz Boustani, MD, MPHPrincipal InvestigatorIndiana University

9 Previous Clinical Trials

15,454 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively seeking participants for this study at the moment?

"Indeed, as per the information provided on clinicaltrials.gov, this trial is presently actively seeking eligible candidates. The trial was initially posted on November 8th, 2023 and underwent its most recent update on January 16th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Digital Detection of Dementia (D Cubed) Studies: D3

MALAZ BOUSTANI 2023. "Digital Detection of Dementia (D Cubed) Studies: D3". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06224205.

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