Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001017819
Ethics application status
Approved
Date submitted
25/06/2021
Date registered
4/08/2021
Date last updated
17/04/2023
Date data sharing statement initially provided
4/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of personalised music listening on quality of life and cognitive abilities in persons with dementia
Scientific title
Effect of personalised music listening on quality of life and cognitive abilities in persons with dementia
Secondary ID [1] 304170 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Music for Dementia (MUDEM)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 321866 0
Cognitive decline 321867 0
Agitation 322829 0
Anxiety 322830 0
Depression 322831 0
Condition category
Condition code
Neurological 319590 319590 0 0
Dementias
Neurological 319591 319591 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Personalised music listening.
Past research has shown listening to music can influence quality of life, cognition, and behavioural/psychological symptoms (BPSD) for people with dementia (Leggieri et al., 2019; Raglio et al., 2015). However, details remain unclear regarding dosage (how much music?), frequency (how often?), and longevity (how long do effects last?). Answering these questions can contribute to developing an evidence-based approach to using music to ease the burden on people with dementia (PWD), their carers, and aged-care facilities. The intervention requires limited staff involvement and is time and cost-effective. Participants diagnosed with dementia living in nursing homes and aged-care facilities will be recruited. The intervention will occur at participating aged-care homes in the Perth region of Western Australia. During the initial interview, a researcher will brief each participant on how the study will evaluate any change in the quality of life after the 12 weeks of the music listening intervention. The effects of personalised music listening via headphones, its frequency and duration on the quality of life of people with dementia will be examined in short-and long-term follow-ups.
Once baseline neuropsychological assessments are completed, interview sessions (approximately one hour) with each participant and aged-care staff or family members will be conducted to select a set of songs or music segments personally meaningful and enjoyable to the participant. Participants will be randomly assigned to one of the following groups (N=12 for each): Group A will listen to personalised music via headphones, placed on their head by nursing home staff between 7:30-10:30am daily for 30 minutes (minimum of 5 days per week). Group B will listen to personalised music via headphones as per Group A, but twice daily (between 7:30-10:30am and 1:30-4:30pm). Group C will listen to audiobooks via headphones, as per Group A (same session duration and intervention duration). Group D will listen to contemporary popular experimenter-chosen music (i.e., not personalised) as per Group A. Group E will not have any intervention (control). All participants will continue to receive their standard care. The personalised music and selected audiobook will be downloaded to the headset. The aged-care staff will monitor the participants and provide information to the study about the people with dementia by taking notes when observing their behaviour alongside their standard duties. Participants will receive the intervention for a period of 12 weeks. The measures taken by the researchers at baseline will be redone at 1.5 months, 3 months, 4.5 months and 6 months. We will test for differences across time and across group to see if the type and amount of the intervention affects the quality of life, behaviour and cognition of participants.
Intervention code [1] 320528 0
Lifestyle
Intervention code [2] 320529 0
Behaviour
Comparator / control treatment
Group E
Control group
Active

Outcomes
Primary outcome [1] 327473 0
We will compare indices of quality of life for dementia patients (as assessed by DEMQOL and DEMQOL-Proxy) taken at baseline (pre-intervention) to those taken at subsequent timepoints (post-intervention: 1.5 months, 3 months, 4.5 months, 6 months after baseline).
Timepoint [1] 327473 0
Baseline, 1.5 months, 3 months, 4.5 months and 6 months after intervention commences.
Secondary outcome [1] 395248 0
We will compare indices of behavioural disturbances as assessed by the Cohen-Mansfield Agitation Inventory (CMAI) for participants at baseline (pre-intervention) to those taken at subsequent timepoints (post-intervention: 1.5 months, 3 months, 4.5 months, 6 months after baseline).
Timepoint [1] 395248 0
Baseline, 1.5 months, 3 months, 4.5 months and 6 months after intervention commences.
Secondary outcome [2] 395249 0
We will compare cognitive function as assessed by the Montreal Cognitive Assessment (MoCA) to that taken at subsequent timepoints (post-intervention: 1.5 months, 3 months, 4.5 months, 6 months after baseline).
Timepoint [2] 395249 0
Baseline, 1.5 months, 3 months, 4.5 months and 6 months after intervention commences.
Secondary outcome [3] 399138 0
We will compare cognitive function as assessed by the Cognitive Decline in the Elderly (IQCODE) for participants at baseline (pre-intervention) to that taken at subsequent timepoints (post-intervention: 1.5 months, 3 months, 4.5 months, 6 months after baseline).
Timepoint [3] 399138 0
Baseline, 1.5 months, 3 months, 4.5 months and 6 months after intervention commences.
Secondary outcome [4] 399139 0
We will compare wellbeing as assessed by the Cornell Scale for Depression in Dementia to that taken at subsequent timepoints (post-intervention: 1.5 months, 3 months, 4.5 months, 6 months after baseline).
Timepoint [4] 399139 0
Baseline, 1.5 months, 3 months, 4.5 months and 6 months after intervention commences.

Eligibility
Key inclusion criteria
Participants must:
1. have a diagnosis of dementia or Alzheimer's disease within the Diagnostic and Statistical Manual of Mental Health Disorders 5 (American Psychiatric Association, 2013), as documented in medical history
2. have a score range between 16 to 24 (within the past 3 years) as measured by the Mini-Mental State Examination (MMSE) (Folstein et al., 1975; Clark et al., 1999)
3. be able to provide informed consent or informed consent to be provided by Proof of Guardianship from family members
4. be able to listen to music. Please note: wearing hearing aids or conditions such as Tinnitus would not affect participation in the study.
5. not be experiencing an acute mental illness
6. reside in aged-care homes
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not:
1. have a history of untreated major psychiatric disorders
2. have cochlear implants
3. have profound hearing loss that has not had any hearing management or treatment and interferes with the ability to hear normally
4. have Lewy body dementia

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)
Allocation concealed via randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Efficacy
Statistical methods / analysis
Participant characteristics at screening will be compared across the five participant groups using a one-way analysis of variance (ANOVA) to test for baseline differences.
Efficacy variables (e.g., Quality of Life Measures for Dementia, CMAI) collected over time will be assessed using repeated-measures ANOVA to test for differences over time (1.5, 3, 4.5 and 6 months), between the five groups.
A mixed-model ANOVA analysis will be used to investigate the effects of personalised music listening on quality of life.
All significant effects will be examined with post hoc tests using corrections for multiple comparisons.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/05/2022
Actual
3/05/2022
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
60
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308548 0
Other
Name [1] 308548 0
Lindsay & Heather Payne Medical Research Charitable Foundation - Perpetual Impact
Country [1] 308548 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street
MURDOCH WA 6150
Country
Australia
Secondary sponsor category [1] 309399 0
Charities/Societies/Foundations
Name [1] 309399 0
Rotary Club of Freshwater Bay
Address [1] 309399 0
PO Box 168
NEDLANDS WA 6909
Country [1] 309399 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308494 0
Human Resources Ethics Committee (Murdoch University)
Ethics committee address [1] 308494 0
Ethics committee country [1] 308494 0
Australia
Date submitted for ethics approval [1] 308494 0
06/05/2021
Approval date [1] 308494 0
30/06/2021
Ethics approval number [1] 308494 0
2021/103

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

Contacts
Principal investigator
Name 110898 0
A/Prof Hamid Sohrabi
Address 110898 0
Murdoch University
College of Science, Health, Engineering and Education
90 South Street
MURDOCH WA 6150
Country 110898 0
Australia
Phone 110898 0
+61 8 9360 6901
Fax 110898 0
Email 110898 0
[email protected]
Contact person for public queries
Name 110899 0
Jon Prince
Address 110899 0
Murdoch University
College of Science, Health, Engineering and Education
90 South Street
MURDOCH WA 6150
Country 110899 0
Australia
Phone 110899 0
+61 8 9360 6670
Fax 110899 0
Email 110899 0
[email protected]
Contact person for scientific queries
Name 110900 0
Jon Prince
Address 110900 0
Murdoch University
College of Science, Health, Engineering and Education
90 South Street
MURDOCH WA 6150
Country 110900 0
Australia
Phone 110900 0
+61 8 9360 6670
Fax 110900 0
Email 110900 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


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.