Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000156280
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
1/02/2018
Date last updated
23/09/2019
Date data sharing statement initially provided
23/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Music Interventions for Dementia and Depression in Elderly care
Scientific title
Music Interventions for Dementia and Depression in Elderly care: International Multicentre cluster randomised control trial
Secondary ID [1] 293277 0
None
Universal Trial Number (UTN)
Trial acronym
MIDDEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 305351 0
depression 305352 0
Condition category
Condition code
Neurological 304634 304634 0 0
Dementias
Mental Health 304635 304635 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group Music Therapy (GMT) will be provided for participants allocated to the first intervention. Groups will comprise of between 7-10 participants. Sessions will be 45 minutes in length, led by a registered music therapist, and the groups will be closed groups (group membership will be fixed throughout the 6-month intervention period). Participants allocated to this condition will partake in 13 weeks GMT held twice per week for the first 13 weeks followed by a further 13 weeks of GMT once per week. Each participant will first receive an individual music therapy assessment delivered by a registered music therapist. This will involve the music therapist sourcing information about the participant’s preferred music via staff and relatives. The music therapist will then explore playing a range of these songs to identify the types of responses the participant gives to each. Music that the participant is particularly responsive to will be noted and used in subsequent music therapy sessions.

Groups in the second intervention, Recreational Choir Singing (RCS), will comprise of at least 10 participants (i.e. 15 – 20). Each session will be 45 minutes in duration and will be led by a musician with choir leading skills and a music degree. In contrast to GMT, the RCS groups may be open (i.e. participants not eligible to enrol in the study but who wish to participate in the choir may join the group). Participants allocated to the RCS group will partake in 13 weeks of recreational choir singing twice per week followed by a further 13 weeks of group recreational choir singing once per week. RCS focuses on singing participant-selected songs akin to a choir context but without the expectation of preparing for a performance. The core principle of RCS is to sing familiar songs in a quasi choir setting, which provides a familiar musical environment for people to experience connectedness with others and enjoyment of music making in a group.

The third intervention combines GMT and RCS, and participants allocated to this condition will partake in 13 weeks of GMT twice per week and RCS twice per week followed by a further 13 weeks of GMT once per week and RCS once per week. Each session of GMT and RCS will be 45 minutes in duration.
Intervention code [1] 299534 0
Treatment: Other
Comparator / control treatment
Participants in the Control condition will not receive any music-based interventions. They will receive standard care and participate in usual activities. Standard care in this trial is defined as the currently acceptable, usual medical treatment and available therapy programs and activities for people who reside in aged care facilities.
Control group
Active

Outcomes
Primary outcome [1] 303862 0
Montgomery–Åsberg Depression Rating Scale
Timepoint [1] 303862 0
Baseline, 3-months, 6-months (primary timepoint), 12 months
Secondary outcome [1] 340307 0
Neuropsychiatric Inventory Questionnaire (NPI-Q; Kaufer et al., 2000)
Timepoint [1] 340307 0
Baseline, 3-months, 6-months, 12-months
Secondary outcome [2] 340308 0
Generic quality of life assessed using the EuroQoL questionnaire (EQ-5D)
Timepoint [2] 340308 0
Baseline, 3-months, 6-months, 12-months
Secondary outcome [3] 340309 0
Disease-specific quality of life assessed using the Quality of Life in Alzheimer's Dementia scale (QOL-AD; Logsdon et al., 2002)
Timepoint [3] 340309 0
Baseline, 3-months, 6-months, 12-months
Secondary outcome [4] 340593 0
All-cause mortality (time to death)
Care staff from the residential care facilities (those involved in the daily care of residents), will report on participant deaths on a monthly basis.
Timepoint [4] 340593 0
Over 12 months
Secondary outcome [5] 340595 0
Medication use:
Data on type (ATC Codes N065, N06) of medication used and any increase or decrease over time will be collected from care staff using the 'medication profile' section of a tailored version of the Client Socio-Demographic and Service Receipt Inventory (CSSRI), or from available databases.
Timepoint [5] 340595 0
Over 12 months
Secondary outcome [6] 340596 0
Costs of the interventions:
Total and component costs of the interventions will be assessed from a societal perspective, including the cost of the intervention as well as statutory health and social care services used, using a tailored version of the Client Socio-Demographic and Service Receipt Inventory (CSSRI).
Timepoint [6] 340596 0
Baseline, 3-months, 6-months, 12-months
Secondary outcome [7] 340597 0
Adverse events:
No adverse effects of music interventions are known from earlier trials. Intervention providers are trained to work closely with and adapt their interventions to the needs of participants in order to avoid adverse reactions. Because little knowledge exists about what the potential adverse events could be, all types of adverse events and serious adverse events (e.g. unexpected worsening of symptoms), whether related or unrelated to the interventions, will be reported.
Timepoint [7] 340597 0
Baseline, 3-months, 6-months, 12-months
Secondary outcome [8] 340598 0
Subjective perceived burden of care staff (those involved in the daily care of residents) assessed using the Professional Care Team Burden Scale
Timepoint [8] 340598 0
Baseline, 3-months, 6-months, 12-months
Secondary outcome [9] 340599 0
Days on sick leave of care staff (those involved in the daily care of residents), as recorded monthly by the employer
Timepoint [9] 340599 0
Over 12 months

Eligibility
Key inclusion criteria
1) Cognitive impairment or dementia, as indicated by a Clinical Dementia Rating (CDR) score of at least 0.5 and a Mini-Mental State Examination (MMSE) score of 26 or less
2) at least mild depressive symptoms, as indicated by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 8;
3) a clinical diagnosis of dementia according to ICD-10 research criteria;
4) at least 65 years of age
5) living in residential care facilities
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who have an existing diagnosis of schizophrenia or who are severely hearing impaired, in short-time care, or unable to tolerate sitting in a chair for the duration of the sessions will be excluded.

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)
In Australia, 48 Residential Care Facilities (n = 500) will be randomised. To ensure allocation concealment, the randomisation list will be created and kept concealed at the central study office in Bergen, Norway.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (block size 4) will be used to ensure that each site will have a balanced distribution between the interventions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All clinical-effectiveness analyses will be on an intention-to-treat basis. Multivariate longitudinal statistical models with adjustment for clustering will be used to test the two main hypotheses of superiority of GMT and RCS to standard care. Each test will use a two-sided 2.5% significance level to retain a family-wise error rate of 5%. Predefined subgroups will be according to age, gender, and diagnosis.

For the health economic analysis, cost-effectiveness acceptability curves will be plotted for each cost-outcome combination to show the likelihood of one treatment being seen as cost-effective relative to another for a range of (implicit) values placed on incremental outcome improvements.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
18/06/2018
Date of last participant enrolment
Anticipated
1/03/2020
Actual
Date of last data collection
Anticipated
31/03/2021
Actual
Sample size
Target
500
Accrual to date
200
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297904 0
Government body
Name [1] 297904 0
National health and Medical Research Council
Country [1] 297904 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] 297068 0
None
Name [1] 297068 0
Address [1] 297068 0
Country [1] 297068 0
Other collaborator category [1] 279813 0
Commercial sector/Industry
Name [1] 279813 0
Uni Research AS
Address [1] 279813 0
Uni Research Health
Nygårdsgaten 112-114
5008 Bergen
Country [1] 279813 0
Norway
Other collaborator category [2] 279814 0
University
Name [2] 279814 0
Aalborg University
Address [2] 279814 0
The Faculty of Humanities
Department of Communication and Psychology - Music Therapy
Rendsburggade 14
9000 Aalborg
Country [2] 279814 0
Denmark

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298954 0
Medicine and Dentistry Human Ethics sub-committee (The University of Melbourne)
Ethics committee address [1] 298954 0
Ethics committee country [1] 298954 0
Australia
Date submitted for ethics approval [1] 298954 0
22/10/2017
Approval date [1] 298954 0
12/01/2018
Ethics approval number [1] 298954 0

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

Contacts
Principal investigator
Name 78774 0
Prof Felicity Baker
Address 78774 0
Department of Music Therapy
The University of Melbourne
234 St Kilda Road
Southbank VIC 3006
Country 78774 0
Australia
Phone 78774 0
+61402172795
Fax 78774 0
Email 78774 0
felicity.baker@unimelb.edu.au
Contact person for public queries
Name 78775 0
Claire Lee
Address 78775 0
Department of Music Therapy
The University of Melbourne
234 St Kilda Road
Southbank VIC 3006
Country 78775 0
Australia
Phone 78775 0
+61413596587
Fax 78775 0
Email 78775 0
lee.y@unimelb.edu.au
Contact person for scientific queries
Name 78776 0
Claire Lee
Address 78776 0
Department of Music Therapy
The University of Melbourne
234 St Kilda Road
Southbank VIC 3006
Country 78776 0
Australia
Phone 78776 0
+61413596587
Fax 78776 0
Email 78776 0
lee.y@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
Individual participant data will not be available as data will be analysed at a group level


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5010Study protocolGold, C. et al., (2019). Music Interventions for Dementia and Depression in ELdery (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial. BMJ Open, 2019;9:e023436. doi:10.1136/bmjopen-2018-023436 Baker, F. A., Tamplin, J., Clark, I. N., Lee, Y-E C., Geretsegger, M., & Gold, C. (2019). Treatment fidelity in music therapy multi-site cluster randomised controlled trial for people living with dementia: The MIDDEL project intervention fidelity protocol. Journal of Music Therapy, 1 - 24. doi: 10.1093/jmt/thy023   
5011Statistical analysis planGold, C. et al., (2019). Music Interventions for Dementia and Depression in ELdery (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial. BMJ Open, 2019;9:e023436. doi:10.1136/bmjopen-2018-023436  


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMusic Interventions for Dementia and Depression in ELderly care (MIDDEL): Protocol and statistical analysis plan for a multinational cluster-randomised trial.2019https://dx.doi.org/10.1136/bmjopen-2018-023436
EmbaseClinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international pragmatic cluster-randomised controlled trial.2022https://dx.doi.org/10.1016/S2666-7568%2822%2900027-7
N.B. These documents automatically identified may not have been verified by the study sponsor.