Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001134617
Ethics application status
Approved
Date submitted
5/10/2023
Date registered
3/11/2023
Date last updated
29/10/2024
Date data sharing statement initially provided
3/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A music intervention for consumer and staff wellbeing in an advanced dementia unit.
Scientific title
A care team delivered music intervention to address consumer and staff wellbeing within a Specialist Advanced Dementia Inpatient Unit.
Secondary ID [1] 310649 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
MATCH-H
Linked study record
The current study is related to trial records ACTRN12618001799246, ACTRN12622000193774, ACTRN12623000350628, and ACTRN12623000937617. 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 331604 0
psychological symptoms of dementia 331605 0
agitation 331606 0
Condition category
Condition code
Neurological 328341 328341 0 0
Dementias
Neurological 328342 328342 0 0
Alzheimer's disease
Neurological 328343 328343 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: A care team delivered music intervention to address consumer and staff wellbeing within a Specialist Advanced Dementia Inpatient Unit.

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 hospital 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 MATCH Music Training Program will be delivered over 84 days: the first 28 days will comprise the use of training using the modules, and from day 28 to day 84, the use of intentional music will be implemented; micro-training sessions led by the music therapist will support care staff.

Who Provided
The care team staff that watch the music training programme and implement the program are staff that are part of the clinical care team. This could include nurses and allied health team members. The music therapist who supports the care team with microsessions is a registered music therapist who is employed by the study site.

How
The MATCH Music Training Program will be viewed online. The micro-training sessions by the music therapist with the care team will take place either in-person or video conference as it determined by if both parties are sharing a shift time. The intervention will be delivered to the consumers in-person.

Where
The intervention will be carried out at the Specialist Advanced Dementia Inpatient Unit.

When and how much
- The care team will be requested to watch each video at least twice to help deepen their understanding of the concepts, extend their skills, and problem-solve barriers to implementation encountered as they implement the music care strategies. This will take a total of 2.5 hours.
- Each study-enrolled care team member will be asked to provide the intervention based on consumers needs. This is due to the pragmatic nature of staff working shifts and the consumer-need-driven intervention.
-The micro-training sessions will be delivered delivered fortnightly as 15-minute individual sessions by the music therapist to each enrolled care-team member.
- The adherence and impact of the staff providing the intervention to the consumers will be captured by a 'Music Usage Log.' After each shift, staff will be asked to record their use of music with consumers as on a music usage log. A note will be added to the existing nursing handover template to remind staff to fill in this log.
Intervention code [1] 327136 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336238 0
Changes in Neuropsychiatric symptoms of consumers measured by the The Neuropsychiatric Inventory – Questionnaire (NPI-Q)
Timepoint [1] 336238 0
Pre-trial: Day 0
Post-trial follow up at: Day 28, Day 56 and Day 84 post-trial commencement
Secondary outcome [1] 427590 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] 427590 0
Pre-trial: Day 0
Post-trial follow up at Day 84 post-trial commencement
Secondary outcome [2] 427591 0
Focus group with the care team to explore enablers, barriers, acceptabiity and adherence. This is a composite outcome that will assess all these given factors together.
Timepoint [2] 427591 0
Post-trial at Day 84 post-trial commencement
Secondary outcome [3] 427592 0
Perceived suitability of the MATCH Music Training Program as measured by the Acceptability E-Scale (AES) – 7 items.
Timepoint [3] 427592 0
Post-trial at Day 84 post-trial commencement
Secondary outcome [4] 427593 0
Assessing effects of the intervention on care team well-being as measured by the Warwick-Edinburgh Mental Well-being Scale.
Timepoint [4] 427593 0
Pre-trial: Day 0
Post-trial follow up at Day 84 post-trial commencement
Secondary outcome [5] 427594 0
Assessing effects of intervention on care team burden as measured by the Professional Care Team Burden scale (Objective Burden Subscale) (PCTB)
Timepoint [5] 427594 0
Pre-trial: Day 0
Post-trial follow up at Day 84 post-trial commencement
Secondary outcome [6] 427596 0
Assessing the effects of the intervention on staff retention as measured by an analysis of staff leave data.
Timepoint [6] 427596 0
Pre-trial: Day 0
Post-trial follow up at Day 84 post-trial commencement
Secondary outcome [7] 427598 0
Understanding the impact of the intervention (Music User Log)
Timepoint [7] 427598 0
Assessed after each intervention with a consumer between day 28 and day 84 post-trial commencement. The entry is to be made before the end of the care-staff shift.
Secondary outcome [8] 427606 0
Changes in Depression in the consumers.
Timepoint [8] 427606 0
Pre-trial: Day 0
Post-trial follow up at: Day 28, Day 56 and Day 84 post-trial commencement
Follow up 3: Day 84
Secondary outcome [9] 427607 0
Changes to levels of neuropsychiatric medications usage and dosage
Timepoint [9] 427607 0
Pre-trial: Day 0
Post-trial follow up at Day 84 post-trial commencement
Secondary outcome [10] 441110 0
Staff knowledge and perception of training.
Timepoint [10] 441110 0
Secondary outcome [11] 441111 0
Staff knowledge and perception of training.
Timepoint [11] 441111 0
Pre-trial: Day 0 Post-trial follow up at Day 84 post-trial commencement

Eligibility
Key inclusion criteria
Inclusion criteria for the care team:
-Registered nurses (RN), enrolled nurses (EN), Assistance in Nursing (AIN), Medical Staff, Allied Health Assistance (AHA), Allied Health Professionals (AHP) or managers who are employed on a regular basis of at least 0.4FTE at the Unit.
- Have given written informed consent.

Inclusion criteria for consumers:
- Consumer at the Unit.
- Documented diagnosis of dementia (any aetiology).
- Consumers with delirium will be included in the study. Their period of delirium during the study will be recorded and considered in the study analysis to examine if delirium affects research outcomes.
- Consent obtained by proxy from legal guardian
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for the care team:
- Care team/staff who work on a casual basis or are scheduled to take annual leave during the study period.

Exclusion criteria for consumers:
- Consumers who do not have a confirmed diagnosis of dementia.

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/11/2023
Actual
20/11/2023
Date of last participant enrolment
Anticipated
30/04/2024
Actual
7/02/2024
Date of last data collection
Anticipated
31/05/2024
Actual
9/05/2024
Sample size
Target
123
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25701 0
Repat Neuro-Behavioural Unit - Daw Park
Recruitment postcode(s) [1] 41525 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 314864 0
Charities/Societies/Foundations
Name [1] 314864 0
Aged Care Research & Industry Innovation Australia (ARIIA) Grant
Country [1] 314864 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville, Vic 3052
Country
Australia
Secondary sponsor category [1] 316968 0
None
Name [1] 316968 0
Address [1] 316968 0
Country [1] 316968 0
Other collaborator category [1] 282834 0
Hospital
Name [1] 282834 0
Repat Neurobehavioural Unit
Address [1] 282834 0
Daw Park, SA 5041
Country [1] 282834 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313865 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 313865 0
Ethics committee country [1] 313865 0
Australia
Date submitted for ethics approval [1] 313865 0
11/09/2023
Approval date [1] 313865 0
10/10/2023
Ethics approval number [1] 313865 0
2023/HRE00217

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129602 0
Prof Felicity Baker
Address 129602 0
Building 141, Office 106, Gate 12, Royal Parade, Parkville, The University of Melbourne, Melbourne, Victoria 3010
Country 129602 0
Australia
Phone 129602 0
+61 0402172795
Fax 129602 0
Email 129602 0
[email protected]
Contact person for public queries
Name 129603 0
Felicity Baker
Address 129603 0
Building 141, Office 106, Gate 12, Royal Parade, Parkville, The University of Melbourne, Melbourne, Victoria 3010
Country 129603 0
Australia
Phone 129603 0
+61 0402172795
Fax 129603 0
Email 129603 0
[email protected]
Contact person for scientific queries
Name 129604 0
Felicity Baker
Address 129604 0
Building 141, Office 106, Gate 12, Royal Parade, Parkville, The University of Melbourne, Melbourne, Victoria 3010
Country 129604 0
Australia
Phone 129604 0
+61 0402172795
Fax 129604 0
Email 129604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The trial involves proprietary technology, which is commercially sensitive and sharing such data could jeopardise intellectual property and competitive advantage.


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.