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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]

None

Universal Trial Number (UTN)

Trial acronym

MIDDEL

Linked study record

Health condition

Health condition(s) or problem(s) studied:

dementia

depression

Condition category

Condition code

Neurological

Dementias

Mental Health

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]

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]

Montgomery–Åsberg Depression Rating Scale

Timepoint [1]

Baseline, 3-months, 6-months (primary timepoint), 12 months

Secondary outcome [1]

Neuropsychiatric Inventory Questionnaire (NPI-Q; Kaufer et al., 2000)

Timepoint [1]

Baseline, 3-months, 6-months, 12-months

Secondary outcome [2]

Generic quality of life assessed using the EuroQoL questionnaire (EQ-5D)

Timepoint [2]

Baseline, 3-months, 6-months, 12-months

Secondary outcome [3]

Disease-specific quality of life assessed using the Quality of Life in Alzheimer's Dementia scale (QOL-AD; Logsdon et al., 2002)

Timepoint [3]

Baseline, 3-months, 6-months, 12-months

Secondary outcome [4]

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]

Over 12 months

Secondary outcome [5]

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]

Over 12 months

Secondary outcome [6]

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]

Baseline, 3-months, 6-months, 12-months

Secondary outcome [7]

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]

Baseline, 3-months, 6-months, 12-months

Secondary outcome [8]

Subjective perceived burden of care staff (those involved in the daily care of residents) assessed using the Professional Care Team Burden Scale

Timepoint [8]

Baseline, 3-months, 6-months, 12-months

Secondary outcome [9]

Days on sick leave of care staff (those involved in the daily care of residents), as recorded monthly by the employer

Timepoint [9]

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?

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]

Government body

Name [1]

National health and Medical Research Council

Address [1]

GPO Box 1421 Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Uni Research AS

Address [1]

Uni Research Health Nygårdsgaten 112-114 5008 Bergen

Country [1]

Norway

Other collaborator category [2]

University

Name [2]

Aalborg University

Address [2]

The Faculty of Humanities Department of Communication and Psychology - Music Therapy Rendsburggade 14 9000 Aalborg

Country [2]

Denmark

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medicine and Dentistry Human Ethics sub-committee (The University of Melbourne)

Ethics committee address [1]

Medicine and Dentistry HESC
The University of Melbourne
Parkville VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/10/2017

Approval date [1]

12/01/2018

Ethics approval number [1]

Summary

Brief summary

This project is investigating how music impacts levels of depression and symptoms of dementia in older people living in residential aged care facilities. It is part of larger international study involving European investigators. The project will study the impact of music on wellbeing for 500 older Australians living in residential care facilities in Australia over a 12-month period. Each facility participating in the study will be randomized into one of 4 groups (1. small music therapy group, 2. recreational group singing, 3. small music therapy group and recreational group singing, 4 standard care). Over the 12-month period, we will be collecting a range of data that will help us understand whether music has or has an effect on participants' mood, quality of life, and symptoms of dementia. Moreover, we will be asking care staff working with participants on a regular basis to complete questionnaires over the 12-month period, to help us understand the impact of the music intervention on caregivers' wellbeing and burden.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Felicity Baker

Address

Department of Music Therapy The University of Melbourne 234 St Kilda Road Southbank VIC 3006

Country

Australia

Phone

+61402172795

Fax

[email protected]

Contact person for public queries

Name

Claire Lee

Address

Department of Music Therapy The University of Melbourne 234 St Kilda Road Southbank VIC 3006

Country

Australia

Phone

+61413596587

Fax

[email protected]

Contact person for scientific queries

Name

Claire Lee

Address

Department of Music Therapy The University of Melbourne 234 St Kilda Road Southbank VIC 3006

Country

Australia

Phone

+61413596587

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No 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.	Type	Citation	Link	Email	Other Details	Attachment
5010	Study protocol	Gold, 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
5011	Statistical analysis plan	Gold, 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

Source	Title	Year of Publication	DOI
Embase	Music Interventions for Dementia and Depression in ELderly care (MIDDEL): Protocol and statistical analysis plan for a multinational cluster-randomised trial.	2019	https://dx.doi.org/10.1136/bmjopen-2018-023436
Embase	Clinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international pragmatic cluster-randomised controlled trial.	2022	https://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.

Trial Review

Documents added manually

Documents added automatically