356 Participants Needed

Montessori-Based Interventions for Dementia

(MAP-VA Trial)

MM
VK
Overseen ByVirginia Keleher
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
Must be taking: Antipsychotics, Sedatives, Benzodiazepines
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on non-drug interventions, so you might not have to stop, but it's best to check with the trial coordinators.

What data supports the effectiveness of the treatment Montessori Approaches to Person-Centered Care (MAP-VA) for dementia?

Research shows that Montessori-based activities, which are part of person-centered care, can improve engagement and emotional well-being in people with dementia. Studies have found that these activities are enjoyable and positively received by both participants and caregivers, although their effectiveness may vary depending on the stage of dementia.12345

Is Montessori-Based Intervention safe for people with dementia?

Montessori-Based Interventions for dementia are generally considered safe, as they focus on engaging activities and improving quality of life without involving medication. However, the effectiveness of these interventions is still rated as weak, and more high-quality research is needed to fully understand their impact.15678

How is the Montessori Approaches to Person-Centered Care (MAP-VA) treatment different from other dementia treatments?

The Montessori Approaches to Person-Centered Care (MAP-VA) treatment is unique because it focuses on person-centered care, emphasizing the abilities, needs, and interests of individuals with dementia. It uses activities and routines that are meaningful to the person, aiming to improve their quality of life by creating a supportive environment tailored to their strengths.12369

Research Team

MM

Michelle Marie Hilgeman, PhD

Principal Investigator

Tuscaloosa VA Medical Center, Tuscaloosa, AL

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.

Timeline

Pre-Intervention Baseline Collection

All sites will start with a baseline collection phase without exposure to the intervention

6 months

MAP-VA Intervention

Montessori approaches to person-centered care (MAP-VA) introduces practical strategies for staff to engage residents

6 months

Follow-up

Participants are monitored for effectiveness and sustainability of the MAP-VA program after intervention

6 months

Treatment Details

Interventions

  • Montessori Approaches to Person-Centered Care (MAP-VA)
Trial Overview The 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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Edith Nourse Rogers Memorial Veterans Hospital

Collaborator

Trials
8
Recruited
362,000+

VA Salt Lake City Health Care System

Collaborator

Trials
25
Recruited
262,000+

The VA Western New York Healthcare System

Collaborator

Trials
9
Recruited
910+

Center for Applied Research in Dementia

Collaborator

Trials
1
Recruited
360+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Providence VA Medical Center

Collaborator

Trials
27
Recruited
72,500+

References

Effects of a culturally adapted group based Montessori based activities on engagement and affect in Chinese older people with dementia: a randomized controlled trial. [2021]
Don't Bother Trying, They Won't Do It! Effect of Responsive Behaviors on the Montessori Assessment System. [2022]
Person-Centered, Skilled Services Using a Montessori Approach for Persons with Dementia. [2019]
Intervention Fidelity of a Volunteer-Led Montessori-Based Intervention in a Canadian Long-Term Care Home. [2021]
A Systematic Review of Montessori-Based Activities for Persons With Dementia. [2018]
Using Normalization Process Theory to Evaluate the Implementation of Montessori-Based Volunteer Visits Within a Canadian Long-Term Care Home. [2020]
[Montessori method applied to dementia - literature review]. [2019]
Origins of Montessori Programming for Dementia. [2021]
Join the Revolution: How Montessori for Aging and Dementia can Change Long-Term Care Culture. [2015]
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