NCT04829500 · ACTIVE NOT RECRUITING
Effectiveness and Implementation of Montessori Approaches in Person-Centered Care Within VA
This trial is testing a staff training program called MAP-VA at eight VA long-term care facilities. The program teaches employees Montessori-based, person-centered care techniques to reduce agitation, aggression, and mood disturbances in residents with dementia or serious mental illness — without relying on extra medication. It is a Phase NA study, meaning it is evaluating a care delivery approach rather than a drug or medical device.
Eligibility criteria
Inclusion Criteria: Residents who meet at least one of the following eligibility criteria will be eligible: * dementia diagnosis or related disorder * Cognitive Function Scale score indicative of impairment * positive Patient Health Questionnaire (PHQ-9) depression score * mental health diagnosis (e.g., ICD-10 codes) * indication of agitation or aggression per MDS behavior items * active prescription for a PRN or scheduled antipsychotic, sedative/hypnotic, or benzodiazepine/anxiolytic Exclusion Criteria: * Residents admitted for hospice or respite care
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-02-10