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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

MAP-VA Trial 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.Check my eligibility
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.See study design
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.

MAP-VA Trial 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.
Select...
I have been diagnosed with dementia or a similar condition.

MAP-VA Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in resident agitation from pre-intervention to post-intervention
Secondary outcome measures
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

MAP-VA 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.

Find a Location

Who is running the clinical trial?

Edith Nourse Rogers Memorial Veterans HospitalFED
7 Previous Clinical Trials
22,962 Total Patients Enrolled
The VA Western New York Healthcare SystemFED
7 Previous Clinical Trials
513 Total Patients Enrolled
VA Salt Lake City Health Care SystemFED
24 Previous Clinical Trials
264,575 Total Patients Enrolled

Media Library

Montessori Approaches to Person-Centered Care (MAP-VA) Clinical Trial Eligibility Overview. Trial Name: NCT04829500 — N/A
Dementia Research Study Groups: Pre-Intervention Baseline Collection Phase, MAP-VA Intervention
Dementia Clinical Trial 2023: Montessori Approaches to Person-Centered Care (MAP-VA) Highlights & Side Effects. Trial Name: NCT04829500 — N/A
Montessori Approaches to Person-Centered Care (MAP-VA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04829500 — N/A
Dementia Patient Testimony for trial: Trial Name: NCT04829500 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for the study participants?

"The clinicaltrials.gov source suggests that recruitment for this medical trial has ceased since its initial posting on May 1st 2021, and the subsequent update of April 18th 2022. However, 461 other studies are actively enrolling participants at present time."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
Tuscaloosa VA Medical Center, Tuscaloosa, AL
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

My doctor says it's something that I could find helpful to my mental health.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Effectiveness and Implementation of Montessori Approaches in Person-Centered Care Within VA
2021. "Effectiveness and Implementation of Montessori Approaches in Person-Centered Care Within VA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04829500.
All > Mental Health
~66 spots leftby Dec 2024
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