Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605157
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
A Multimodal Music Therapy Intervention for Engaging Persons with Severe Dementia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Randomized Clinical Trial of a Multimodal Music Therapy Intervention for Engaging Persons with Severe Dementia AMUSED
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMUSED
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
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 ie 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 measures 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
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 ie 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 measures 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None