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A new tool aims to shield dementia patients from neglect

NCT ID NCT07758738

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study tests whether screening for elder neglect in primary care, combined with a caregiver support app, can reduce neglect in older adults with dementia. Researchers will compare three groups: one receiving screening alone, one receiving screening plus the SIRENS app, and one receiving standard care. Participants include older adults with dementia and their caregivers, who will complete questionnaires and attend clinic visits over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A screening tool to identify elder neglect and a mobile app (SIRENS) that provides caregivers with expert-reviewed information and goal-setting support.
What this could lead to
If effective, this approach could help primary care clinics spot elder neglect earlier and provide caregivers with tools to reduce harm, improving safety and well-being for people with dementia.
What could go wrong
The trial is still in progress, and results may not show a clear benefit. Screening and support may not change outcomes for all caregivers, and the app's impact may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 774 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Weill Cornell Medicine

    New York, New York, 10065, United States

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Other studies related to the condition(s) this trial covers.