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Trial registered on ANZCTR


Registration number
ACTRN12623000937617
Ethics application status
Approved
Date submitted
2/08/2023
Date registered
30/08/2023
Date last updated
19/10/2024
Date data sharing statement initially provided
30/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Music Attuned Technology for Care via eHealth – MATCH (Study 3.3)
Scientific title
Music Attuned Technology for Care via eHealth – MATCH: Proof-of-Concept MATCH App in Residential Aged Care with Professional Carers and People living with Dementia (Study 3 - Stage 3)
Secondary ID [1] 310281 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
MATCH - Study 3.3
Linked study record
Trial Id: ACTRN12618001799246 - HOMESIDE RCT - tested the effectiveness of training family caregivers to use music with people living with dementia at home.
Trial Id: ACTRN12622000193774 - MATCH: Proof-of-Concept (Study 2) - tested the MATCH app in the community setting - training family caregiver via app.
Trial Id: ACTRN12623000350628: MATCH: Determining Digital Markers of Agitation (Study 3 - Stage 2) uses the part of the same sample in the same Residential Aged Care Unit

Health condition
Health condition(s) or problem(s) studied:
behavioural symptoms of dementia 330976 0
psychological symptoms of dementia 330977 0
agitation 330978 0
Condition category
Condition code
Neurological 327779 327779 0 0
Dementias
Neurological 327780 327780 0 0
Alzheimer's disease
Neurological 327781 327781 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Residential Aged Care (RAC) Staff (care staff or carer) working with residents living with Dementia (PwD or residents) will receive training (MATCH Music Training Program) in the strategic use of music to manage behavioural and psychological symptoms of dementia (BPSD). (a) The training will be administered online via a mobile application (MATCH App). (b) The training is composed of five modules, lasting 2.5 hours. (c) Each of the five modules (‘Relaxation’, ‘Mood Regulation’, ‘Engagement and Connection’, ‘Supporting Personal Care’, and ‘Movement/Exercise’) comprises instructional and demonstration videos, guides and a sample music playlist. Care staff will be instructed on how to choose music, engage the PwD in daily activities, create opportunities for meaningful dialogue with the PwD, and learn clues about the PwD’s positive and negative responses to music. The activities to be taught comprise (i) singing familiar/preferred music followed by carer-facilitated discussions about the meaning of the songs for the PwD and significant others and any associated memories; (ii)movement/exercise (e.g. upper body and arms imitating familiar dance movements to music) to assist in regulating mood; and (iii) listening to familiar/preferred relaxing or enlivening music dependent upon present at the time to assist in regulating mood. After watching the training videos, care staff will be guided to try some methods learned with the residents. The care staff are instructed to use music purposefully when the resident presents dementia symptoms during the 8-week trial period. Researchers will contact care staff weekly to support them in using strategies and how they are progressing with using the music or any adverse event and answer any questions they may have. The mobile app will provide access to music and record information of use for each carer and resident and prompt impact evaluation to keep track of the effects of each music session. This information will inform the carer of the progress of using music for each resident.
Intervention code [1] 326660 0
Treatment: Devices
Intervention code [2] 326661 0
Behaviour
Comparator / control treatment
No comparator will be used at this phase
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335629 0
Effectiveness of implementation of MATCH Music Training Program in the management of behavioural and psychological symptoms of dementia, assessed by changes in Neuropsychiatric Inventory - Nurse Home version (NPI-NH) between baseline and eight weeks post-trial assessment
Timepoint [1] 335629 0
Pre-trial (baseline) and post-trial at 8 weeks
Secondary outcome [1] 425009 0
Knowledge gained in the MATCH Music Training Program, using a questionnaire designed specifically for this study between baseline and 8 weeks post-trial assessment
Timepoint [1] 425009 0
Pre-trial (baseline) and post-trial at 8 weeks
Secondary outcome [2] 425010 0
Perceived suitability of the MATCH App and the MATCH Music Training Program, using the Acceptability E-Scale (AES)– 7 items, in the post-trial assessment
Timepoint [2] 425010 0
Post-trial at 8 weeks
Secondary outcome [3] 425011 0
Usability of the mobile application, System Usability Scale (SUS)– 10-items , in the post-trial assessment
Timepoint [3] 425011 0
Post-trial at 8 weeks
Secondary outcome [4] 425012 0
Adherence to the MATCH Music Training Program and Music intervention will be captured by the App log as the users reach the mobile application to be trained and use the music
Timepoint [4] 425012 0
As intervention and review training is needed.
Secondary outcome [5] 425013 0
Enablers and barriers affecting the adoption of the MATCH Music Training Program and MATCH App will be identified through semi-structured interviews conducted post-trial. The interviews will prompt participants to reflect on what circumstances made it easy or difficult for them to use the app effectively. Interviews will be conducted in person or via Zoom, depending upon participant preferences.
Timepoint [5] 425013 0
Post-trial (week 9-10)
Secondary outcome [6] 425014 0
Medication – participants’ medication usage will be logged retrospectively at the end of the study. Researchers will complete the log with information from residents’ medication charts and via discussion with RAC care staff where necessary to verify any changes in PRN medication due to the use of strategies learned in the study.
Timepoint [6] 425014 0
During trial (weeks 1 - 8)
Secondary outcome [7] 425016 0
In-App Impact Assessment. The Impact Assessment is a feature of the MATCH app – when the professional carer initiates music for the resident in the App, they are prompted by a pop-up window to record the reason they are using music with a specific resident. After the end of the session, they are asked to rate how effective the music was in addressing the reason they selected at the start of the session. The assessment takes less than one minute for the carer to complete.
Timepoint [7] 425016 0
As intervention is needed.

Eligibility
Key inclusion criteria
Inclusion criteria for care staff:
• Direct care staff who provide regular care to residents, who are employed on a regular basis of at least 0.4FTE at RAC OR
• Registered nurses, enrolled nurses, non-clinical staff, lifestyle staff or managers who are employed on a regular basis at the RAC
• Have given written informed consent

Inclusion criteria for residents:
• Resident (full-time, 24 hours/day) at a participating care home
• Documented diagnosis of dementia
• Has given written informed consent, or verbal assent with written consent by proxy for those legally unable to provide consent themselves
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for care staff:
• Staff who work on a casual basis
• Staff who do not work directly with residents (e.g. management positions)

Exclusion criteria of residents:
• Residents 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
We will conduct a single-arm Proof-of-Concept (POC) study of the MATCH App in RAC with professional care staff and residents to evaluate the usability, acceptability, preliminary effectiveness, and identify enablers and barriers to use. Co-design workshops/focus groups post-trial will enable the research team to improve the MATCH App further. A POC study is a ‘pre-market pilot’ study designed to provide an initial test of medical devices in a defined population or indication before definitive testing in large trials. POC can be used at an exploratory stage to test preliminary safety, performance and user acceptability. This often precedes confirmatory studies, such as randomised controlled trials, to minimise research waste in early development phases.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The percentage of correct scores for the training evaluation quiz will be calculated for each participant, and means and standard deviations reported. Descriptive statistics will be used to examine acceptability and usability. Adherence will be calculated by examining the frequency of app/music use per participant. Effect sizes will be calculated for the pre-post scores for NPI-NH.

Field notes and interview data will be analysed using thematic analysis. We will use reflexive thematic analysis to analyse the interview, researcher field notes, and co-design workshop data. The interviews and workshop discussions will be recorded and transcribed. Research team members will take field notes recording their observations of the co-design workshop sessions. Transcripts and field notes will be reviewed carefully by two research team members who will identify the core themes relating to user experience, enablers and barriers to adoption and use, and opportunities for further design and development of the app. The thematic analysis will predominantly involve inductive approaches (seeking themes from within the data).


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2023
Actual
16/03/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
24/05/2024
Date of last data collection
Anticipated
31/08/2024
Actual
10/09/2024
Sample size
Target
80
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314486 0
Government body
Name [1] 314486 0
Medical Research Future Fund (National Health and Medical Research Council)
Country [1] 314486 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Faculty of VCA and MCM
University of Melbourne
234 St Kilda Road VIC 3006
Country
Australia
Secondary sponsor category [1] 316438 0
None
Name [1] 316438 0
Address [1] 316438 0
Country [1] 316438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313533 0
The University of Melbourne - HASS 1
Ethics committee address [1] 313533 0
Ethics committee country [1] 313533 0
Australia
Date submitted for ethics approval [1] 313533 0
22/07/2022
Approval date [1] 313533 0
03/10/2022
Ethics approval number [1] 313533 0
2023-24870-43080-11

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

Contacts
Principal investigator
Name 128478 0
Prof Felicity Baker
Address 128478 0
Faculty of Fine Arts and Music
Melba Hall Building – Parkville Campus
The University of Melbourne Victoria 3010
Country 128478 0
Australia
Phone 128478 0
+61 402 172 795
Fax 128478 0
Email 128478 0
[email protected]
Contact person for public queries
Name 128479 0
Tanara Vieira Sousa
Address 128479 0
Faculty of Fine Arts and Music
Melba Hall Building – Parkville Campus
The University of Melbourne Victoria 3010
Country 128479 0
Australia
Phone 128479 0
+61 403159473
Fax 128479 0
Email 128479 0
[email protected]
Contact person for scientific queries
Name 128480 0
Tanara Rosangela Vieira Sousa
Address 128480 0
Faculty of Fine Arts and Music
Melba Hall Building – Parkville Campus
The University of Melbourne Victoria 3010
Country 128480 0
Australia
Phone 128480 0
+61 403 159 473
Fax 128480 0
Email 128480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identified data regarding validated tools as validated tools over time (e.g. NPI-NH), will be made available after the end of the MATCH Project, including manuscripts published in a Public Data Repository.
When will data be available (start and end dates)?
01/01/2027 - to unlimited timeline.
Available to whom?
To the general public
Available for what types of analyses?
No restrictions
How or where can data be obtained?
Assessing the Public public Data Repository or via email to the PI Professor Felicity Baker: [email protected].


What supporting documents are/will be available?




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.