Status:
RECRUITING
A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia
Lead Sponsor:
Alaine E Hernandez, PhD
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Dementia Severe
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The goal of this pilot randomized clinical trial is to learn if a music therapy treatment, called AMUSED, can improve engagement and reduce behavioral symptoms in older adults with severe dementia who...
Detailed Description
Meaningful activity has personal importance or usefulness, fosters a sense of fulfillment, and contributes to well-being, whether through cherished pastimes or goal-oriented endeavors. Persons with de...
Eligibility Criteria
Inclusion
- PARTICIPANT
- 65 years or older
- late-onset dementia diagnosis from a physician
- stable at facility long enough to establish residency and routine at the facility (about 2 months prior to start of study)
- English is primary language (for pilot study practicality and ensure straightforward evaluation of our aims)
- Dementia is severe: As in the feasibility study, residents' charted score on the Brief Inventory of Mental Status (BIMS) \< 7 will be used and no independent function in community affairs, hobbies, chores, or personal care. The BIMS is a component of the Minimum Data Set (MDS), a federally mandated clinical assessment for all residents in US Medicare and Medicaid certified care facilities. It is completed periodically and interpreted by a licensed health care professional employed by the facility who has completed requisite training on the assessment.
- PARTICIPANT Exclusion criteria:
- music therapy recipient
- co-occurring movement disorder
- preexisting cognitive disability
- Milder dementia (BIMS 7+); Persons with more significant cognitive decline could arguably respond differently to the intervention than those with milder dementia, a notion that is supported by past music therapy research with this population.
- FACILITIES -
- Any facility in Kentucky that provides residential care for persons with severe dementia (up to 8 facilities).
- At least 5 residents must enroll to make the best use of our resources.
- At least 1 facility staff member available to help with recruitment and periodic observable data collection
- Can accommodate consistent session days and times between lunch and dinner, 2 times per week for 40 minutes, for 12 weeks.
- Willing to communicate questions, concerns, and changes in safety protocols to the research team.
- Can provide a space appropriate for a small group activity (3-5 residents plus a group leader).
- Can ensure staff support is available for safely transitioning participants to/from sessions at the agreed upon session days and time.
- Can assert that music therapy from a credentialed music therapist (MT-BC) is not offered by the facility, to prevent "double dosing" (music entertainment is ok).
- FACILITIES -
Exclusion
- Does not meet one or more inclusion criteria.
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06605157
Start Date
March 12 2025
End Date
June 30 2026
Last Update
March 17 2025
Active Locations (2)
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1
University of Kentucky
Lexington, Kentucky, United States, 40506
2
Windsor Care Center
Mount Sterling, Kentucky, United States, 40353