~72 spots leftby Apr 2026

Montessori-Based Interventions for Dementia

(MAP-VA Trial)

Recruiting in Palo Alto (17 mi)
Overseen byMichelle Marie Hilgeman, PhD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: VA Office of Research and Development
No Placebo Group

Trial Summary

What is the purpose of this trial?

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 (community or VA) and sustainability is rarely examined. Aims: This 4-year study will examine both the effectiveness of the MAP-VA program on resident outcomes, person-centered care practices, and organizational culture as well as an evaluation of the implementation barriers to adopting MAP-VA in a sustainable way over a 12 month period. Staff and residents at 8 CLCs will participate in the study.

Eligibility Criteria

This trial is for Veterans with dementia or serious mental illness in VA long-term care, showing symptoms like agitation or aggression. They must have a cognitive impairment score indicating issues and may be on medications like antipsychotics or sedatives. It's not for those in hospice or respite care.

Inclusion Criteria

You have been diagnosed with a mental health condition, such as depression or anxiety.
Showing signs of being very upset or acting aggressively according to a specific behavior assessment.
I am currently prescribed medication for psychosis, sleep, or anxiety.
See 5 more

Exclusion Criteria

People who are staying in a hospice or respite care facility.

Treatment Details

Interventions

  • Montessori Approaches to Person-Centered Care (MAP-VA) (Behavioural Intervention)
Trial OverviewThe study tests the Montessori Approaches to Person-Centered Care (MAP-VA) program at 8 VA Community Living Centers. It aims to improve resident outcomes and staff practices by addressing behavioral symptoms of dementia without relying solely on medication.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: MAP-VA InterventionExperimental Treatment1 Intervention
Montessori approaches to person-centered care (MAP-VA) introduces practical strategies that frontline staff can use for successful engagement of residents through retained abilities such as implicit learning, procedural memory, reading abilities. Staff training provides practice with: 1) pre-developed activities and templates, 2) a simple reading assessment to inform development of external cues; and 3) identifying opportunities for increased independence and resident contribution to community routines. Staff are also introduced to concrete strategies that improve dignity, control, and independence.
Group II: Pre-Intervention Baseline Collection PhaseActive Control1 Intervention
All sites will start with a baseline collection phase without exposure to the intervention, consistent with the stepped wedge cluster randomized trial design. A sequential randomized crossover to the intervention (MAP-VA) will be assigned, which cannot be reversed once it has been introduced.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Tuscaloosa VA Medical Center, Tuscaloosa, ALTuscaloosa, AL
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Who Is Running the Clinical Trial?

VA Office of Research and DevelopmentLead Sponsor
Edith Nourse Rogers Memorial Veterans HospitalCollaborator
VA Salt Lake City Health Care SystemCollaborator
The VA Western New York Healthcare SystemCollaborator
Center for Applied Research in DementiaCollaborator
University of Alabama at BirminghamCollaborator
Providence VA Medical CenterCollaborator

References