- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03174717
Evaluating an Individualized Music Program Intervention in Long-term Care
Study Overview
Detailed Description
There is abundant research identifying the value of music in improving quality of life for older adults in residential faculties. This work suggests that there are at least two critical factors that contribute to the success of music-based interventions for older adults: familiarity, and active participation in the production of the music. With these elements in mind, the investigators are proposing to develop a choral singing program comprised of familiar music, introduced to residents at a Long-term care (LTC) facility through individualized engagement with the songs, leading to weekly group participation run by a professional musician at the Bonne Bay (Newfoundland and Labrador, Canada) Long-term Care Facility.
Specific development of the choral program itself will be done through a co-design process involving staff, residents, and care partners during the intervention. In general the intervention will have residents work with professional musicians to select a few songs that the residents will perform with the professional musician at the end of the week. The specific development will determine three crucial issues for the intervention: 1) what music is appropriate for the initiative? 2) what individualized engagements with the songs are appropriate to each resident? 3) what modes of participation in the group events are appropriate to each resident? The key factor with this co-design are that the music and the level of engagement will be tailored to the individual resident.
The program will run over a full quarter in (July, August, September) allowing the investigators to establish meaningful comparisons of secondary, quantitative data already collected at all long-term care facilities on a quarterly basis. This data includes the medication administration (medication administration records: MARS), behavioural episodes in residents with dementia (dementia observational system: DOS), and the resident assessment inventory minimum data set (RAI-MDS). Pre and post intervention data will be assessed for participating residents at the Bonne Bay Long-term care facility. Pre-intervention data will be collected for three years before the intervention to establish an appropriate baseline for the intervention. The impact of the intervention on residents of the unit will also be assessed through qualitative data. Interviews with residents or their care partners will elicit the perceived benefits and challenges to participating in a music intervention program from the participants' point of view. Care-partners will be identified by nursing staff and/or the resident themselves as an individual who regularly helps with day-to-day living needs of the resident. Care partners will only be interviewed when the cognitive abilities of the resident prevent conducting an interview with them. All participants in the study will be de-identified using a code system that allows us to intersect quantitative and qualitative data in pursuit of a more rigorous view of potential impacts. This code system will involve randomly assigning each participant a number. A master database connecting the name and the number will be maintained in a password protected file on a password protected computer in Dr. Zendel's lab. Research staff will use this master database under the supervision of one of the data custodians during the de-identification process.
This intervention will also be studied from the staff perspective. While there are few studies investigating the perceptions of staff in the implementation of music intervention in healthcare settings, those that are published document the importance of considering the staff perspective and the impact of this perspective on the overall success of this form of intervention. A 'pre/post' interview process will engage how the music intervention was perceived by staff, particularly regarding workload, role in the intervention, strengths and challenges of the intervention, and the impact on overall work environment. Gaining an understanding of the staff perspective on the implementation of this intervention will prove invaluable to the overall feasibility of the initiative.
A final layer of inquiry will interview the musicians themselves, exploring a sense of meaning and value gained through participation in the process, distinctions the musicians make between music and music as intervention, how the musician defines and relates to their practice as musicians, what and how that has shifted, what relationship the musician felt emerged between themselves and the residents with whom they worked?
Basic demographic information including age, date of birth and sex will be recorded as part of each interview (residents/care partners, music staff and LTC staff). Demographic information will also be collected from the residents chart.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Resident, staff at Bonne Bay LTC, or musician performing at the Bonne Bay LTC
Exclusion Criteria:
- everyone else
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Music intervention
LTC residents will participate in an individualized music performance with a musician
|
residents of LTC will learn and perform songs with musicians from the community
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PRN drug use in LTC residents
Time Frame: 12 weeks
|
12 weeks
|
|
Behavioural assessments
Time Frame: 12 weeks
|
RAI-MDS
|
12 weeks
|
Experience of LTC residents
Time Frame: 12 weeks
|
Qualitative assessment via interview with residents
|
12 weeks
|
Experience of LTC staff
Time Frame: 12 weeks
|
Qualitative assessment via interview with staff
|
12 weeks
|
Experience of Musicians
Time Frame: 12 weeks
|
Qualitative assessment via interview with musician
|
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LTCMusic
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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