Digital Detection of Dementia (D3) Studies
M
Malaz Boustani, MD
Primary Investigator
Overview
To evaluate the predictive performance of the Passive Digital Marker (PDM), the Quick Dementia Rating System (QDRS), and the combined (PDM + QDRS) approach in the early detection of Alzheimer's Disease and Related Dementia (ADRD), compared to the gold standard diagnoses. our interdisciplinary scientific team is proposing to execute a clinical validation study, one pragmatic trial and one additional replicated pragmatic trial among patients from diverse rural, suburban and urban primary care practices in two independent sites located in central Indiana and south Florida.
Description
The first study will be a single-arm clinical validation (NIH Stage III) study of our developed early ADRD detection approaches; Passive Digital Marker (PDM) and the Patient Reported Outcome (PRO) tool, the Quick Dementia Rating System (QDRS) for discriminating gold standard ADRD diagnoses for a sample of 400 older primary care patients served in the two states (Indiana and Florida)
The other studies will be two independent pragmatic cluster-randomized controlled comparative effectiveness (NIH Stage IV) trials to incorporate the PDM and the QDRS within the Medicare paid Annual Wellness Visit (AWV) for a cohort of patients from practices across the two independent sites, with practices randomized in each pragmatic trial to one of the 3 arms (the AWV alone, the AWV with PDM, and the AWV with both the PDM and the QDRS).).
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Dementia, Alzheimers
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Age: Between 65 Years - 100 Years
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Gender: All
Inclusion Criteria:
- 65 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 two or three years
Exclusion Criteria:
- 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
Updated on
02 May 2024.
Study ID: 2008372812, INTM-IIR-D3
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