Clinical trial NCT06605157: A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia
Official title: Pilot Randomized Clinical Trial of A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia (AMUSED)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia Severe
Keywords: Music Therapy
Evidence-based practice
Behavioral symptoms
Speech
Language
Artificial intelligence
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-09-20
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To prevent cross-contamination, a research team member will randomize facilities as clusters (N=8) 1:1 to either the music or the reading intervention using a random number table. Opting for four clusters per arm will enable the researchers to estimate cluster effects and evaluate delivery across different care structures. The researchers will enroll at least 5 participants from each cluster/facility to provide a buffer against attrition to maintain a group of at least 3 individuals in each cluster. Delivery of both music and reading is in small groups (3-5 people).
Primary purpose: SUPPORTIVE_CARE

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 live in care facilities. The main questions it aims to answer are:

* Is it feasible to conduct a full-scale trial of AMUSED?
* Can investigators identify the best outcome measures to assess impact on behavioral symptoms of dementia?
* Does speech offer a useful indicator of treatment effectiveness? Researchers will compare a group-based music therapy treatment to a reading activity to learn if music therapy leads to greater improvements in behavioral symptoms and speech patterns.

Participants will:

* Participate in either music therapy (includes live music, singing, and rhythmic instrument playing) or a reading group with stories about life and nature and talk about memories.
* Attend small group sessions twice a week for 12 weeks, with each session lasting 40 minutes between lunch and dinner.
* Be observed and assessed for behavioral symptoms, cognition, and speech several times during treatment and at a 4-week follow-up.

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 dementia (PWD) experience significant deficits in memory, communication, and functional abilities, which poses unique obstacles to engage in meaningful activities. When PWD lack sufficient activity, or if activities are poorly tailored to ability, PWD can demonstrate increased behavioral symptoms. Such symptoms impact the PWD and contribute to caregiver stress. Nonetheless, PWD across the severity continuum often respond favorably to music. Thoughtfully designed music-based interventions (MBIs) may offer PWD opportunities to engage in meaningful activity and socialize. However, empirical evidence to support the use of MBIs with this population is very limited. This pilot study advances a line of research to test and refine a randomized clinical trial design and gather preliminary data on intervention effectiveness beyond a single session.

The overall objectives of this quantitative pilot study are to (i) establish a well-refined clinical trial design, procedures, and outcome measures and (ii) obtain preliminary data of enduring effectiveness of a multimodal music therapy intervention for engaging persons with severe dementia (AMUSED) with regards to behavioral symptoms and speech. AMUSED uses live participant-preferred music and progressively layers singing, touch, and rhythmic instrument playing concurrent with participant behavioral responses. This MBI is grounded in the person-centered Clinical Practice Model for PWD, which provides guidelines for adjusting the degree of support and challenge offered to an individual. This Model is also used to enhance treatment fidelity.

This pilot study builds on a feasibility study that field tested logistics and demonstrated feasibility and acceptability of the AMUSED intervention protocol through a randomized cross-over trial design. The researchers refined recruitment, data collection, protocol training, and intervention processes. As in past similar work, the researchers demonstrated positive engagement during music therapy sessions. However, obtaining longer-term measures of treatment effects (i.e., neuropsychiatric inventory, Fitbit actigraphy, pulse oximetry, functional measures) proved impractical and unreliable in the care milieu. The researchers' recent qualitative work with long-term care staff revealed possible solutions to more feasibly measure such outcomes in a long-term care setting. The current pilot study builds on this past feasibility and qualitative work.

In this quantitative pilot study, the investigators will use a randomized clinical trial design to test methods and procedures that will be used in a future larger clinical trial. This will help enhance the rigor and reproducibility of this research. The aims of this pilot study are to: 1) determine whether the clinical trial protocol is feasible for a full-scale trial, 2) select the most appropriate primary outcome measure(s) of behavioral symptoms of dementia, and 3) determine if spontaneous speech offers a useful indicator of music-based intervention effectiveness in persons with severe dementia. Participants will be older adults with severe dementia who live in a long-term care facility. To isolate the effects of the music and obtain an estimate of cluster effects, care facilities will be randomly assigned to either receive music therapy or reading. Both conditions use the same structure, strategies, and dosage, with music being the key difference.

Eligibility criteria: PARTICIPANT Inclusion Criteria:

* 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 - Inclusion Criteria:

* 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 Criteria:

-Does not meet one or more inclusion criteria.

Primary outcomes:
measure: Mean Change from Baseline in Dementia Behavior at 12 Weeks
timeFrame: Baseline, end of Week 12
Secondary outcomes:
measure: Mean Change from Baseline in Dementia Behavior at 4 Weeks
timeFrame: Baseline, end of Week 4
measure: Mean Change from Baseline in Dementia Behavior at 8 Weeks
timeFrame: Baseline, end of Week 8
measure: Mean Change from Baseline in Dementia Behavior at 4-Week Follow-Up (16 Weeks)
timeFrame: Baseline, 4-week follow up (week 16; 4 weeks after removal of treatment)
measure: Mean Change from Baseline in Language Function at 12 Weeks
timeFrame: Enrollment, end of Week 12
measure: Mean Change from Baseline in Cognition at 12 Weeks
timeFrame: Enrollment, end of Week 12
measure: Mean Change from Baseline in Cognition at 4-Week Follow-Up
timeFrame: Baseline, 4-week follow up (week 16; 4 weeks after removal of treatment)
Other outcomes:
measure: Mean Change in Spontaneous Speech at Week 4
timeFrame: Immediately before and immediately after session 8 at week 4
measure: Mean Change in Spontaneous Speech at Week 8
timeFrame: Immediately before and immediately after session 16 at week 8
measure: Mean Change in Spontaneous Speech at Week 12
timeFrame: Immediately before and immediately after session 24 at week 12
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Mt. Sterling
country: United States
facility: Windsor Care Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Alaine E. Reschke-Hernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Reschke-Hernandez AE, Tranel D. Strategies to enhance treatment fidelity and music-based intervention reporting in dementia research. Transl Behav Med. 2024 May 24;14(6):353-358. doi: 10.1093/tbm/ibae003.
citation: Reschke-Hernandez, A.E., Ross, M., Davis, H.R., Latham, E.F. and Veblen, N.B. (2023), Multimodal music therapy intervention for engagement and agitation reduction for persons with severe dementia: Study protocol of a pilot randomized cross-over trial. Alzheimer&#39;s Dement., 19: e080171. https://doi.org/10.1002/alz.080171
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citation: Reschke-Hernández, A. E. (2021). The Clinical Practice Model for Persons with Dementia: Application to music therapy. Music Therapy Perspectives, 39(2), 133-141. https://doi.org/10.1093/mtp/miab006
citation: Reschke-Hernández, A. E. (2019). A clinical practice model of music therapy to address psychosocial functioning for persons with dementia: Model development and randomized clinical crossover trial (NCT03643003). Doctoral dissertation, University of Iowa. https://doi.org/10.17077/etd.59oh-y06y
citation: Profyri E, Leung P, Huntley J, Orgeta V. Effectiveness of treatments for people living with severe dementia: A systematic review and meta-analysis of randomised controlled clinical trials. Ageing Res Rev. 2022 Dec;82:101758. doi: 10.1016/j.arr.2022.101758. Epub 2022 Oct 13.
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