NCT07758738 · NOT YET RECRUITING
Primary Care Screening and Intervention for Patients With Dementia and Caregivers
This trial is testing a screening and support program called SIRENS, designed to detect neglect of older adults with dementia in primary care settings. It also tests whether a caregiver support intervention, added on top of screening, reduces neglect further. Three groups are compared: standard care, screening alone, and screening plus the caregiver program. This is a Phase NA behavioral study — it is evaluating a care process, not a drug.
Eligibility criteria
Primary care provider Inclusion Criteria • Active PCP who may be a physician or nurse practitioner seeing adult primary care patients with dementia at: Weill Cornell Medicine Primary care provider Exclusion Criteria • Not a PCP of older adults with dementia who may be at risk of being neglected. Older Adult Inclusion Criteria: * Aged ≥ 60 years * Community-dwelling * Patient of WCM/NYP * Has diagnosis of dementia (based on medical records prior to enrollment) * Requires assistance with at least 1 ADL * Able to travel to a WCM/NYP clinic for study activities * Has informal (either unpaid or CDPAP) caregiver who provides ≥8 hours weekly * Not already known to be experiencing neglect from caregiver Older Adult Exclusion Criteria: * In hospice * Decision has already been made to re-locate to an institution (including long-term care skilled nursing facilities) Caregiver Inclusion Criteria: * Age ≥ 21 years * Living with or near the older adult * Self-identifies as a caregiver for the older adult * Provides ≥ 8 hours per week of direct care (may include logistics, oversight, observation, as well as hands-on care, but must include at least some in-person assistance) * Able to travel to a WCM/NYP clinic for study activities or participate in study activities virtually through Zoom on their personal device * Not a professional caregiver, does not receive direct payment in return for care (unless through CDPAP) * Can read and speak English at a 6th grade level * No active plan to disengage from providing care to older adult within the next year Caregiver Exclusion Criteria: * Unable to read and speak English at a 6th grade level * Hired/paid professional caregiver * Is blind or deaf * Active plan to disengage from providing care to older adult within the next year
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-08-11