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NCT04481568 · ClinicalTrials.gov registry record · NA

Reducing Behavioral and Psychological Symptoms of Dementia: Family Caregivers (Aim 1)

A NA study, sponsored by Northwell Health.

Completed
Registry status
NA
Development phase
158
Enrollment target

NCT04481568: Completed NA study, sponsored by Northwell Health.

NCT04481568 is a NA study that has completed, run by Northwell Health. The registered enrollment target is 158 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04481568, a NA study, has completed, sponsored by Northwell Health.

COMPLETED
Registry status
NA
Development phase
158 participants
Enrollment target

Study Summary

Persons with Alzheimer's Disease and Related Dementias (ADRD) account for 3.2 million hospital admissions per year and have over three times more hospitalizations than those without cognitive impairment, yet hospital caregivers (HCGs) are ill-prepared to manage patients with ADRD with less than 5% reporting mandatory dementia care training. Three-quarters of hospitalized persons with ADRD display Behavioral and Psychological Symptoms of Dementia (BPSD) associated with functional and cognitive decline, increased resource consumption, institutionalization, premature death, and caregiver burden. The overall objective is to test the preliminary efficacy of an innovative model of care, PES-4-BPSD, for reducing BPSD by empowering Patient Engagement Specialists (PES) to deliver dementia care for acutely-ill patients with ADRD. Traditionally, mental health assistants with training in crisis-prevention techniques provide care to psychiatric patients. On the intervention unit, these mental health assistants, as PES, purposefully engage patients with BPSD. In the pilot study, investigators found patients with cognitive impairment admitted to the PES unit were significantly less likely to require constant observation, chemical and physical restraints, suggesting improved management of BPSD. The central hypothesis is that PES-4-BPSD will improve the ability of PES to create an "enabling" milieu that addresses factors leading to BPSD and improves the experience of hospital caregivers. Guided by a social-ecological framework, PES-4-BPSD incorporates dementia education and training, environmental modifications-cohorting, increased staffing-PES, and staff support. The investigators' multidisciplinary research team is well-positioned to accomplish the following: Aim 1) Determine the preliminary efficacy of PES-4-BPSD for reducing BPSD during hospitalization, and Aim 2) Evaluate whether dementia care training improves the perceived ability of PES staff (intervention) and nurse assista

Primary Outcome

The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms. A Research Coordinator (RC) will utilize a multimodal ap

Interventions

  • BEHAVIORAL PES-4-BPSD Model
  • BEHAVIORAL The attention control condition

Trial Details

FieldValue
Enrollment Target 158 participants
Start Date 2020-02-03
Est. Completion 2021-12-29
Phase NA
Northwell Health

370 total trials

What the finished NCT04481568 record still lists

NCT04481568 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which PES-4-BPSD Model is the first listed.

NCT04481568 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04481568 about?

NCT04481568 is a clinical study titled "Reducing Behavioral and Psychological Symptoms of Dementia: Family Caregivers (Aim 1)". Persons with Alzheimer's Disease and Related Dementias (ADRD) account for 3.2 million hospital admissions per year and have over three times more hospitalizations than those without cognitive impairment, yet hospital caregivers (HCGs) are ill-prepared to manage patients with ADRD with less than 5% r...

What is the current status of trial NCT04481568?

This trial is currently completed. It is a NA study. The enrollment target is 158 participants. The study started on 2020-02-03. Estimated completion is 2021-12-29.

What interventions are being tested in trial NCT04481568?

The interventions under investigation include: PES-4-BPSD Model (BEHAVIORAL), The attention control condition (BEHAVIORAL).

Who is sponsoring clinical trial NCT04481568?

This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04481568's enrollment target sits among peer trials

158 654th of 2000 higher than 1,345 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04481568, the US trial registry maintained by the National Library of Medicine. NCT04481568 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.