Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000677505
Ethics application status
Approved
Date submitted
13/05/2024
Date registered
28/05/2024
Date last updated
28/05/2024
Date data sharing statement initially provided
28/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Feasibility Trial Examining the Use of Music Therapy Informed Strategies During Dementia Care on Professional Caregivers in Residential Aged Care Facilities
Scientific title
Music Attuned Technology for Care via eHealth – MATCH: A Randomised Feasibility Trial Examining the Use of MATCH Strategies During Dementia Care on Professional Caregivers in RACFs
Secondary ID [1] 312044 0
None
Universal Trial Number (UTN)
Trial acronym
MATCH in RAC
Linked study record
The current study is related to trial records ACTRN12618001799246, ACTRN12622000193774, ACTRN12623000350628, ACTRN12623000937617 and ACTRN12623001134617.. These studies each utilise the MATCH app and
ACTRN12623000350628 also shares the study population with the current record.

Health condition
Health condition(s) or problem(s) studied:
behavioural symptoms of dementia 333650 0
stress 333651 0
psychological symptoms of dementia 333652 0
agitation 333653 0
job satisfaction 333654 0
Condition category
Condition code
Neurological 330340 330340 0 0
Alzheimer's disease
Neurological 330341 330341 0 0
Dementias
Mental Health 330342 330342 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Why: MATCH is an eHealth solution, “Music Attuned Technology Care via eHealth,” developed to support carers of people living with dementia to use music intentionally to support care. It is a scalable solution for the growing number of people living with dementia. We developed the ‘MATCH Music Training Program’ as part of this package, which we will trial in a residential aged care setting in this study

Materials: We will use the MATCH Music Training Program for this project. The MATCH program was developed to support carers of people living with dementia to use music intentionally to support care. There are five training modules. The modules are mood regulation, relaxation, engaging and connecting, supporting personal care and movement and exercise. Each training module contains an instructional video, three to five demonstration videos of people with dementia and their carers performing the activities, tips to optimise the implementation of the activities and scenarios of what can go wrong and how to respond. Each module will also guide the carer to create a playlist suitable to the activities being taught in each module. Suggested playlists for each module will be provided.

Procedures: The intervention period is 8-weeks. Participating residential aged care facilities will be cluster randomised using block randomisation to the MATCH, MATCH+ or control group (care as usual). The MATCH intervention will include completing the MATCH training program and using the MATCH application with residents during the intervention period. The MATCH+ group will complete the MATCH training program training, use the application and have additional support from an onsite music therapist and through their multidisciplinary team.

How
The MATCH Music Training Program will be viewed online. Caregivers will access the MATCH training program via REDCap a secure database, which they will access via a unique participant website link which will be emailed to them upon enrolment. During the trial period, the caregivers will also have access to the training program directly from the MATCH app, which they will access via a mobile device, should they wish to review any of the instructional or demonstration videos. The MATCH training program will take 1 hour 15 minutes and will be completed within a 2-week period, directly preceding the intervention period.

Upon commencing the intervention period and using the MATCH application, caregivers will be encouraged to use the application any time they determine it may be helpful for a resident to engage in a music experience. Caregivers will be asked to use the MATCH application at least 1.5 hours per week during the trial period and application analytics will be used to monitor adherence. The MATCH application allows caregivers to play personalised music playlists to support relaxation, reminiscence, movement, mood regulation and personal care routines. Residents may be offered music to listen to via speakers or headphones at different times throughout the day. The duration of the intervention, what intervention (which playlist, accompanying movement, breathing, reminiscence, or other), when to use the intervention, and intention of the intervention is determined by the caregiver based on their assessment of the resident’s needs in the moment. Only caregivers who have completed the MATCH training program will be administering the MATCH app intervention. It is predicted that caregivers will primarily use the intervention one-on-one when assisting residents with personal care, however they may choose to implement group music interventions if they deem they may be beneficial for residents.

The music therapist will provide face to face support once per fortnight to participants in the MATCH+ group. The music therapist will be at the care home for up to 6 hours on one day each fortnightly and can provide support to caregivers as needed. Should caregiver participants not work full time, the music therapist will rotate the day they spend onsite to maximise the opportunities caregivers have to access this support. This may include demonstrating MATCH strategies, for example, synchronising with the rhythm of the music and selecting appropriate music to assist a resident regulate their mood. To monitor adherence to the intervention, MATCH application analytics will be monitored by the researcher.

The care homes in the MATCH+ group will be encouraged to support caregivers to embed the MATCH music strategies into care. In multidisciplinary team meetings (that regularly take place at the care home in usual practice), caregivers will be encouraged to seek support from their multidisciplinary team via discussion and as needed to identify intervention needs. For example, caregivers will be encouraged to ask nurse and allied health team members perspective on when a resident may benefit from relaxation, mood regulation or other support.

Where
The intervention will be carried out in residential aged care facilities who support people living with dementia.

Focus group interviews
All caregivers from the MATCH and MATCH+ arms will be invited to participate in focus group interviews at 12-week post-baseline follow up. The focus group process will leverage dynamic interaction in a semi-structured approach to provide insight into caregiver’s experiences and opinions. In line with the explanatory design questions will be emergent and refined based on preliminary quantitative results. Up to six participants will participate in each focus group, to allow sufficient time and space for discussion and equitable participation. The focus groups will run for a planned 60-minutes and up to a maximum of 90 minutes. These groups will either be an in-person or online depending on availability. The focus group will be conducted by the graduate researcher who is also the music therapist providing support in the MATCH+ care homes. All interviews will be audio-recorded and transcribed by the graduate researcher for analysis.
Intervention code [1] 328491 0
Behaviour
Comparator / control treatment
The control group will continue care as usual. This may include caregivers using music with residents to support care, however these will be standard practice, rather than the music therapist informed strategies learned in the intervention group. After the intervention period the control group will have access to use the MATCH training program and application.
Control group
Active

Outcomes
Primary outcome [1] 338105 0
Feasibility
Timepoint [1] 338105 0
Recrutiment and retention rates will be assessed upon completion of the study.
Focus group interviews will be conducted at the 12-week post-baseline follow-up.
Researcher field notes will be collected throughout the intervention period and analysed upon conclusion of the study.
Secondary outcome [1] 434530 0
Changes in job satisfaction for the care team as a result of the intervention as measured by the Measure of Job Satisfaction (MJS) Scale.
Timepoint [1] 434530 0
Pre-trial and post-8-week trial
Secondary outcome [2] 434531 0
Changes in perceived stress for the care team as a result of the intervention as measured by the Perceived Stress Scale (PSS).
Timepoint [2] 434531 0
Pre and post-8-week trial
Secondary outcome [3] 434533 0
Changes in caregivers confidence using music in care as a result of the intervention as measured by the Caregiver Confidence Using Music Scale (CCuMS).
Timepoint [3] 434533 0
Pre and post 8-week trial
Secondary outcome [4] 434534 0
Changes in caregivers knowledge of using music in care as a result of the intervention as measured by a researcher designed questionnaire.
Timepoint [4] 434534 0
Pre and post 8-week trial.
Secondary outcome [5] 434535 0
Explore caregivers experiences of using MATCH and MATCH+ strategies in care including enablers, barriers, acceptability of outcome measures. This will be assessed as a composite outcome.
Timepoint [5] 434535 0
Week 12 follow up
Secondary outcome [6] 434536 0
Understanding caregivers engagement with the MATCH application
Timepoint [6] 434536 0
Throughout trial period (8-weeks).
Secondary outcome [7] 434537 0
Changes in residents psychological and behavioural symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI-NH). This will be assessed as a composite outcome.
Timepoint [7] 434537 0
Pre and post 8-week trial

Eligibility
Key inclusion criteria
Care facilities inclusion criteria:
• 50% of residents are reported to have a diagnosis of dementia

Caregivers inclusion criteria:
• Professional caregiver (job title may include but not limited to: personal care assistant, care worker, care aide) employed at the participating RACF
• Able to complete online questionnaire and training in English language
• Able to provide written informed consent

Residents inclusion criteria::

• Full time resident (24 hours/day) at participating RACF
• Documented diagnosis of dementia, as reported by family ember/guardian.
• Written informed consent provided (or verbal assent with written consent by proxy for those legally unable to self-consent)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Care home exclusion criteria:
• Facilities currently under sanction from the Aged Care Quality Standards Commission are excluded.

Caregiver exclusion criteria;
• working < 0.4 FTE
• working at facility for < 3 months
• Under performance review
• working in a position that requires an enrolled or registered nurse qualification.
• working at the participating RACF on a casual basis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Feasibility of the study will be evaluated by examining the recruitment and retention rates, pre-post variability of primary outcome measures, frequency of app/music use per participant (primary aim).

Quantitative data:
Descriptive statistics and pre-post variability (preliminary effect sizes) will be used to examine caregivers perceived stress, self-efficacy, job satisfaction, confidence, and knowledge of using music in care. Percentage of correct scores for the training evaluation quiz will be calculated.

Qualitative data:
To understand the quantitative research through caregivers’ experiences of using MATCH focus group interviews will be recorded and transcribed. The researchers field notes will also provide qualitative data. Thematic analysis will be used to analyse qualitative data and address the primary and secondary aims. The researcher will conduct the thematic analysis in consultation with and under the supervision of the research team.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
16/08/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316405 0
Government body
Name [1] 316405 0
Medical Research Future Fund (National Health and Medical Research Council)
Country [1] 316405 0
Australia
Funding source category [2] 316558 0
University
Name [2] 316558 0
Research Training Program Scholarship - University of Melbourne
Country [2] 316558 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318576 0
None
Name [1] 318576 0
Address [1] 318576 0
Country [1] 318576 0
Other collaborator category [1] 283018 0
Commercial sector/Industry
Name [1] 283018 0
Curtin Heritage Living (residential aged care organisation)
Address [1] 283018 0
Country [1] 283018 0
Australia
Other collaborator category [2] 283019 0
Commercial sector/Industry
Name [2] 283019 0
Hall & Prior (residential aged care organisation)
Address [2] 283019 0
Country [2] 283019 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315201 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 315201 0
https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees
Ethics committee country [1] 315201 0
Australia
Date submitted for ethics approval [1] 315201 0
24/04/2024
Approval date [1] 315201 0
20/05/2024
Ethics approval number [1] 315201 0
2024-29289-53535-3

Summary
Brief summary
MATCH is an eHealth solution, “Music Attuned Technology Care via eHealth,” developed to support carers of people living with dementia to use music intentionally to support care. It is a scalable solution for the growing number of people living with dementia. We developed the ‘MATCH Music Training Program’ as part of this package, which we will trial 2 MATCH interventions in residential aged facilities in this feasibility study to inform future powered trials.
Trial website
www.musicattunedcare.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133962 0
Prof Felicity Baker
Address 133962 0
Building 141, Office 106, Gate 12, Royal Parade, Parkville, The University of Melbourne, Melbourne, Victoria 3010
Country 133962 0
Australia
Phone 133962 0
+61 0402172795
Fax 133962 0
Email 133962 0
felicity.baker@unimelb.edu.au
Contact person for public queries
Name 133963 0
Hayley Antipas
Address 133963 0
Building 141, Office 106, Gate 12, Royal Parade, Parkville, The University of Melbourne, Melbourne, Victoria 3010
Country 133963 0
Australia
Phone 133963 0
+61 0431156421
Fax 133963 0
Email 133963 0
hantipas@student.unimelb.edu.au
Contact person for scientific queries
Name 133964 0
Hayley Antipas
Address 133964 0
Building 141, Office 106, Gate 12, Royal Parade, Parkville, The University of Melbourne, Melbourne, Victoria 3010
Country 133964 0
Australia
Phone 133964 0
+61 0431156421
Fax 133964 0
Email 133964 0
hantipas@student.unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.