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Montessori-Based Interventions for Dementia (MAP-VA Trial)

N/A

Waitlist Available

Led By Michelle Marie Hilgeman, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Residents with active prescription for a PRN or scheduled antipsychotic, sedative/hypnotic, or benzodiazepine/anxiolytic

Residents with dementia diagnosis or related disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effectiveness of the MAP-VA program on resident outcomes, person-centered care practices, and organizational culture, as well as the implementation barriers to adopting MAP-VA in a sustainable way over a 12 month period.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since MAP-VA involves non-pharmacological interventions focusing on staff training and system improvements rather than direct medical treatments, it does not have typical side effects associated with drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently prescribed medication for psychosis, sleep, or anxiety.

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I have been diagnosed with dementia or a similar condition.

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I have been diagnosed with dementia or a similar condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated)

This trial's timeline: 3 weeks for screening, Varies for treatment, and primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in resident agitation from pre-intervention to post-intervention

Secondary study objectives

Change in patient-centered care practices / organizational culture from pre-intervention to post-intervention

Change in resident mood from pre-intervention to post-intervention

Change in resident psychotropic medication use from pre-intervention to post-intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met