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NCT04829500 · ClinicalTrials.gov registry record · NA

Effectiveness and Implementation of Montessori Approaches in Person-Centered Care Within VA

A NA study of Dementia or a Related Disorder and Mental Health Diagnoses, sponsored by VA Office of Research and Development.

Active
Registry status
NA
Development phase
356
Enrollment target
1
Study location

NCT04829500: Active NA study of Dementia or a Related Disorder and Mental Health Diagnoses, sponsored by VA Office of Research and Development.

NCT04829500 is a NA study of Dementia or a Related Disorder and Mental Health Diagnoses that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 356 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04829500, a NA study of Dementia or a Related Disorder and Mental Health Diagnoses, is active but no longer recruiting, sponsored by VA Office of Research and Development.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
356 participants
Enrollment target
1
Study location

Study Summary

Background: Addressing behavioral and neuropsychiatric symptoms of Veterans with dementia and serious mental illness (SMI) such as schizophrenia can be challenging for staff in VA long-term care settings, called Community Living Centers or CLCs. These behaviors of distress (agitation, aggression, and mood disturbance) are not just associated with staff stress and burnout; they also hasten residents' functional decline, decrease quality of life, and increase mortality. Staff training in non-pharmacological interventions can be effective. Yet systems barriers, task-based care models, and time constraints often result in staff employing "quicker," less effective strategies. Montessori Approaches to Person-Centered Care for VA (MAP-VA)- a staff training, intervention, and delivery toolkit- developed in collaboration with VA operational partners, Veterans, and frontline CLC staff is positioned to respond to this challenge. The investigators' prior work shows probable impacts on CLC quality indicators at the individual and unit level (e.g., psychotropic medications, depressive symptoms, weight loss, falls, pain). The goal of this study is to evaluate the MAP-VA program and necessary supports for a successful implementation at 8 VA CLCs. Significance/ Innovation: VHA's Modernization Plan focuses on empowering front-line staff to lead quality improvement efforts like the ones taught through MAP-VA. MAP-VA is distinct from existing interventions in its: 1) application to Veterans with a range of diagnoses and cognitive abilities; 2) emphasis on pairing practical skill-building for staff with overcoming system-level barriers that inhibit person-centered care; and 3) engagement of all staff rather than a reliance on provider-level champions. Yet, MAP-VA is a complex intervention that requires participation of multiple stakeholder groups, making implementation facilitation necessary. To date, no studies have evaluated MAP implementation success in operational settings (communi

Primary Outcome

Staff-reported observations of resident agitation will be collected over time using the Cohen-Mansfield Agitation Inventory (CMAI). The CMAI is a widely used, valid measure of agitation frequency for older adults across diagnoses in NH settings. Staff rate 29 behaviors over the past two weeks (1=never to 7=several times/hr) across four subscales: verbally nonaggressive behaviors, verbally aggressive behaviors, physically nonaggressive behaviors, and physically aggressive behaviors. Higher scores

Interventions

  • BEHAVIORAL Montessori Approaches to Person-Centered Care (MAP-VA)

Study Locations (1)

Alabama

  • Tuscaloosa VA Medical Center, Tuscaloosa, AL - Tuscaloosa

Trial Details

FieldValue
Enrollment Target 356 participants
Start Date 2021-05-01
Est. Completion 2025-11-01
Phase NA
VA Office of Research and Development

1,668 total trials

What the registry record for NCT04829500 still lists

NCT04829500 is an interventional study that assigns participants to a tested intervention. The registered 356 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 (75% lower).

The record links to 3 conditions, with Dementia or a Related Disorder appearing as the primary indexed condition, and to 1 intervention - of which Montessori Approaches to Person-Centered Care (MAP-VA) is the first listed.

NCT04829500 reports a single indexed study location in Alabama.

Frequently Asked Questions

What is clinical trial NCT04829500 about?

NCT04829500 is a clinical study titled "Effectiveness and Implementation of Montessori Approaches in Person-Centered Care Within VA". Background: Addressing behavioral and neuropsychiatric symptoms of Veterans with dementia and serious mental illness (SMI) such as schizophrenia can be challenging for staff in VA long-term care settings, called Community Living Centers or CLCs. These behaviors of distress (agitation, aggression, an...

What is the current status of trial NCT04829500?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 356 participants. The study started on 2021-05-01. Estimated completion is 2025-11-01.

What conditions does trial NCT04829500 study?

This clinical trial studies the following conditions: Dementia or a Related Disorder, Mental Health Diagnoses, Symptoms of Agitation or Aggression.

What interventions are being tested in trial NCT04829500?

The interventions under investigation include: Montessori Approaches to Person-Centered Care (MAP-VA) (BEHAVIORAL).

Who is sponsoring clinical trial NCT04829500?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04829500 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04829500's enrollment target sits among peer trials

356 291st of 2000 higher than 1,710 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 NCT04829500, the US trial registry maintained by the National Library of Medicine. NCT04829500 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.