Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000193774
Ethics application status
Approved
Date submitted
21/01/2022
Date registered
4/02/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
4/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Music Attuned Technology for Care via eHealth – MATCH - Study 2
Scientific title
Music Attuned Technology for Care via eHealth – MATCH: Proof-of-Concept (Study 2)
Secondary ID [1] 306256 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MATCH - Study 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
behavioural symptoms of dementia 324986 0
psychological symptoms of dementia
 324987 0
Agitation 324988 0
Condition category
Condition code
Neurological 322429 322429 0 0
Dementias
Neurological 322430 322430 0 0
Alzheimer's disease
Neurological 322431 322431 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Family caregivers (FCs) will receive training to use Music Intervention (MI). The training will be delivered via a mobile application and comprises training and case study videos, guides and a sample music playlist instructing the FCs on methods and strategies for using music to assist the person living with dementia (PwD) to become calmer (if agitated) or more energised (if apathetic). FCs will be instructed on how to choose music and engage the PwD in effective and respectful discussions with the aim of evoking autobiographical memories and sharing meaningful experiences. Strategies to engage the PwD and create opportunities for meaningful dialogue with the PwD will be provided, as well as training FCs to notice the PwD’s positive and negative responses to music. The activities to be taught comprise a) singing familiar/preferred music followed by FC-facilitated discussions about the meaning of the songs for the dyad, the PwD, and significant others, and any associated memories; b) movement to music (e.g. upper body and arms imitating familiar dance movements to music) to assist in regulating arousal; and c) listening to familiar/preferred relaxing or enlivening music dependent upon behavioural and psychological symptoms of dementia (BPSD) present at the time to assist in regulating arousal. Following watching the training videos, the FC will be guided to try out some of the methods learned with the PwD. The time required for training will depend on the Dyad needs: the five available modules have video duration varying from 12 to 70 minutes. For example, if the dyad needs are related to relaxation, the time to watch the videos twice is 25 minutes. If the needs are related to movement, a module with a safety checklist will add to training techniques to support the choice of safe movements for the PwD, taking the training time to 70 minutes. The FCs can return to the material always when it is needed. The FCs are then instructed to use music in a purposeful way at least 5x per week for approximately 30 mins over an 8-week period. Weekly phone conversations (up to 15 minutes each) with FCs will be used to support the FC, check-in as to how they are progressing with the use of the music or any adverse event and answer any questions they may have.
Intervention code [1] 322717 0
Treatment: Devices
Intervention code [2] 322718 0
Behaviour
Comparator / control treatment
No comparator will be used at this phase
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330190 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 Questionnaire (NPI-Q) between baseline and 8 weeks post-trial assessment
Timepoint [1] 330190 0
Pre-trial (baseline) and post-trial at 12 weeks
Primary outcome [2] 330335 0
Update Effectiveness of implementation of MATCH Music Training Program in the management of Agitation assessed by Cohen Mansfield Agitation Inventory (CMAI) between baseline and 8 weeks post-trial assessment
Timepoint [2] 330335 0
Pre-trial (baseline) and post-trial at 8 weeks
Secondary outcome [1] 405231 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] 405231 0
Pre-trial (baseline) and post-trial at 8 weeks
Secondary outcome [2] 405232 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] 405232 0
Post-trial at 8 weeks
Secondary outcome [3] 405233 0
Usability of the mobile application, System Usability Scale (SUS)– 10-items , in the post-trial assessment
Timepoint [3] 405233 0
Post-trial at 8 weeks
Secondary outcome [4] 405234 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 and by reports in the diary.
Timepoint [4] 405234 0
At least twice weekly (2-30 min each time) per 8 weeks
Secondary outcome [5] 405235 0
Enablers and barriers affecting the adoption of the MATCH Music Training Program and MATCH App, will be identified through semi-structured interviews conducted pre-, mid- and post-trial (3 interviews). 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 over the phone or via zoom depending upon participant preferences ).
Timepoint [5] 405235 0
Pre-trial, 4-weeks and Post-trial (8-weeks)
Secondary outcome [6] 410602 0
Impact on Mood during use of App: The in-app Mood Assessment is an updated feature of the application – when the user begins listening to music in the application, they are prompted by a pop-up window to rate their mood based on a series of 12 options (presented using words and emojis). The mood assessment pops up again after 15 minutes to rate any change in mood. The assessment takes less than one minute for the user to complete. This helps us to track real-time how the music may be impacting the mood of the users, and also prompts users to reflect on the impact that the music is having themselves, which adds to their learning.
Timepoint [6] 410602 0
During use of App (15 minute intervals)

Eligibility
Key inclusion criteria
Inclusion criteria of people living with dementia:
• Home co-habiting with at least one other person who nominates to be the primary caregiver.
• No age limits are stipulated so people with early onset of dementia may also be included.
• Formal diagnosis of Mild Cognitive Impairment or Dementia.

Inclusion Criteria of Family Caregivers:
• close in relationship to the person living with dementia
• co-habiting with the person with dementia.

Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Dyads where there is no access to the internet or a mobile device where the app needs to be downloaded and accessed for study participation.
• Hearing impairment that is not overcome by hearing support such as hearing aids for both family carer and person living with dementia
• The carer does not have good knowledge of English. This is because the first minimum viable product is a mobile app version with basic features and only in English. Versions in other languages should be available as intermediate or advanced features in the mobile app.

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
Other design features
The single-arm Proof-of-Concept (POC) study of MATCH-MVP by family carers will be implemented to evaluate the usability, acceptability, preliminary effectiveness, and identify enablers and barriers to use. Co-design workshops post-trial will enable the research team to make further improvements to the MATCH-MVP. 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 studies are more frequently used in the assessment of safety and dose size in pharmacological interventions, however during the initial phases of the development of medical devices they can be used at an exploratory stage to test preliminary safety, performance and user acceptability (TGA, 2021). 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
Statistical methods / analysis
Effect-sizes will be calculated for the pre-post scores for NPI-Q and Cohen-Mansfield Agitation Inventory (Primary Outcome). The percentage of correct scores for the training evaluation (Knowledge gained) 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.

We will use reflexive thematic analysis (Braun and Clarke, 2006; Terry and Hayfield, 2021) to analyse the interview, free-text diary entries, and co-design workshop data. The interviews and workshop discussions will be recorded and transcribed. Members of the research team will take fieldnotes recording their observations of the co-design workshop sessions. Transcripts and field notes will be reviewed carefully by two members of the research team 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
8/06/2022
Actual
4/07/2022
Date of last participant enrolment
Anticipated
1/08/2022
Actual
12/01/2023
Date of last data collection
Anticipated
31/03/2023
Actual
2/04/2023
Sample size
Target
32
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310604 0
Government body
Name [1] 310604 0
Medical Research Future Fund (National Health and Medical Research Council)
Country [1] 310604 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] 311798 0
None
Name [1] 311798 0
Address [1] 311798 0
Country [1] 311798 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310209 0
The University of Melbourne - HASS 1
Ethics committee address [1] 310209 0
Ethics committee country [1] 310209 0
Australia
Date submitted for ethics approval [1] 310209 0
18/10/2021
Approval date [1] 310209 0
14/12/2021
Ethics approval number [1] 310209 0
2022-22807-28789-8

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

Contacts
Principal investigator
Name 116870 0
Prof Felicity Baker
Address 116870 0
Faculty of Fine Arts and Music
The University of Melbourne
234 St Kilda Rd, Southbank
Melbourne Victoria 3006
Country 116870 0
Australia
Phone 116870 0
+61 402 172 795
Fax 116870 0
Email 116870 0
[email protected]
Contact person for public queries
Name 116871 0
Tanara Vieira Sousa
Address 116871 0
Faculty of Fine Arts and Music
The University of Melbourne
234 St Kilda Rd, Southbank
Melbourne Victoria 3006
Country 116871 0
Australia
Phone 116871 0
+61 403 159473
Fax 116871 0
Email 116871 0
[email protected]
Contact person for scientific queries
Name 116872 0
Felicity Baker
Address 116872 0
Faculty of Fine Arts and Music
The University of Melbourne
234 St Kilda Rd, Southbank
Melbourne Victoria 3006
Country 116872 0
Australia
Phone 116872 0
+61 402 172 795
Fax 116872 0
Email 116872 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 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14745Clinical study report  [email protected] By request to the Principal Investigator or via th... [More Details]
14746Ethical approval  [email protected] Attached 383453-(Uploaded-21-01-2022-14-26-18)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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