Primary Care Screening and Intervention for Patients With Dementia and Caregivers (NCT07758738) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Primary Care Screening and Intervention for Patients With Dementia and Caregivers
United States774 participantsStarted 2026-11-01
Plain-language summary
The goal of this clinical trial is to evaluate the impact of screening for elder neglect in older adults with dementia in primary care settings and the impact of an intervention for caregivers of older adults with dementia.
The hypothesis of the study are:
* Neglect screening in primary care will have a positive impact on outcomes including a decrease in presence of neglect at 6 months and other patient and caregiver outcomes
* Neglect screening paired with a caregiving intervention will have a greater impact on these outcomes than screening alone
Researchers will compare three groups of participants to find out how effective the screening tool is on its own, and how effective it is when combined with the support program, compared to standard care.
Participants will be asked to:
* attend primary care clinic visits
* complete questionnaires
* participate in the intervention
* participate in a semi-structured interview
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent change in number of participants with the presence of neglect determined by the Vulnerable Elder Protection Team (VEPT) from baseline at 6 months
Timeframe: Baseline; 6 months
Trial details
NCT IDNCT07758738
SponsorWeill Medical College of Cornell University