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Trial registered on ANZCTR


Registration number
ACTRN12618001690246
Ethics application status
Approved
Date submitted
10/10/2018
Date registered
12/10/2018
Date last updated
22/08/2019
Date data sharing statement initially provided
22/08/2019
Date results information initially provided
22/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving quality of life and mental health using a music engagement program people for aged-care residents with Alzheimers disease and dementia
Scientific title
Evaluating a music engagement program on quality of life and mental health for aged-care residents with Alzheimers disease and dementia
Secondary ID [1] 296305 0
None
Universal Trial Number (UTN)
U1111-1222-0876
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 310008 0
quality of life 310009 0
Condition category
Condition code
Mental Health 308763 308763 0 0
Depression
Neurological 308764 308764 0 0
Dementias
Neurological 308765 308765 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will comprise 45-60min group singing sessions led by a highly experienced music facilitator, with ~15 residents weekly for 8 weeks at an aged-care facility in Canberra. The music program is based on a social model of music-making, which does not place central importance on technical skill, but on joyful and sustained engagement. The program involves shared participation in the singing (or listening if preferred) of a program of songs relevant to the target age group. This program was developed iteratively using up to 30 years of feedback. The program runs for 8 weeks only, so if a participant enrols in the final week, they will only receive 1 week of the program.
Intervention code [1] 312635 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307740 0
Depression as assess by the Cornell Scale for Depression in Dementia (19 items - measuring depression and related wellbeing items e.g., anxiety, appetite, agitation)
Timepoint [1] 307740 0
Post-intervention (8 weeks)
Primary outcome [2] 307741 0
Quality of life - a single item using a visual analogue survey based on the WONCA Functional Health Status Charts
Timepoint [2] 307741 0
Immediately after each Music Engagement Program (MEP) session (post-session).
Primary outcome [3] 307742 0
Social connectedness - a single item using a visual analogue survey based on the WONCA Functional Health Status Charts.
Timepoint [3] 307742 0
Immediately after each MEP session (post-session).
Secondary outcome [1] 352757 0
Nil
Timepoint [1] 352757 0
Nil

Eligibility
Key inclusion criteria
Participants must be residents of the aged-care facility targeted.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A mixed methods evaluation of brief pre- and post-session measures of wellbeing (quality of life, social connectedness), and pre- and post-intervention (8 weeks) measures of mental health outcomes (depression) in aged-care residents with Alzheimers disease or dementia.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 300902 0
University
Name [1] 300902 0
The Australian National University
Address [1] 300902 0
Acton ACT 2601
Country [1] 300902 0
Australia
Primary sponsor type
Individual
Name
Amelia Gulliver
Address
Centre for Mental Health Research
Research School of Population Health
The Australian National University
63 Eggleston Road
Acton, ACT 2602
Country
Australia
Secondary sponsor category [1] 300467 0
Individual
Name [1] 300467 0
Georgia Pike
Address [1] 300467 0
Centre for Research on Ageing, Health and Wellbeing
Research School of Population Health
The Australian National University
54 Mills Road
Acton ACT 2601
Australia
Country [1] 300467 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301672 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 301672 0
ANU Human Research Ethics Committee
36 Science Road, ANU
Canberra, ACT, 2601
Australia
Ethics committee country [1] 301672 0
Australia
Date submitted for ethics approval [1] 301672 0
28/09/2018
Approval date [1] 301672 0
23/10/2018
Ethics approval number [1] 301672 0

Summary
Brief summary
This single group trial aims to evaluate the effectiveness of a music engagement program in improving quality of life and depression in aged-care residents with Alzheimers disease and dementia. We hypothesise that residents' indicators of quality of life (including feelings of social connectedness to others and emotional mood) will improve from pre to post session. We also hypothesise that residents' symptoms of depression will improve from pre- to post-intervention (8 weeks).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87734 0
Dr Amelia Gulliver
Address 87734 0
Centre for Mental Health Research
The Australian National University
63 Eggleston Road
Acton, ACT 2602
Country 87734 0
Australia
Phone 87734 0
+61261259472
Fax 87734 0
Email 87734 0
amelia.gulliver@anu.edu.au
Contact person for public queries
Name 87735 0
Dr Amelia Gulliver
Address 87735 0
Centre for Mental Health Research
Research School of Population Health
The Australian National University
63 Eggleston Road
Acton, ACT 2602
Country 87735 0
Australia
Phone 87735 0
+61261259472
Fax 87735 0
Email 87735 0
amelia.gulliver@anu.edu.au
Contact person for scientific queries
Name 87736 0
Dr Amelia Gulliver
Address 87736 0
Centre for Mental Health Research
Research School of Population Health
The Australian National University
63 Eggleston Road
Acton, ACT 2602
Country 87736 0
Australia
Phone 87736 0
+61261259472
Fax 87736 0
Email 87736 0
amelia.gulliver@anu.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
No individual data will be made available.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 4171 0
Study protocol
Citation [1] 4171 0
Gulliver A, Pike G, Banfield M, Morse AR, Katruss N, Pescud M, McMaster M, Valerius H, West S. (2019). Evaluation of the Music Engagement Program for people with Alzheimer's disease and dementia: Study protocol for a pilot trial. Contemporary clinical trials communications, 15, 100419. doi:10.1016/j.conctc.2019.100419
Link [1] 4171 0
Email [1] 4171 0
Other [1] 4171 0
Attachment [1] 4171 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 4177 0
Conference abstract
Citation/DOI/link/details [1] 4177 0
A presentation will be conducted at TheMHS in 2019. A paper and public summary is forthcoming.
Attachments [1] 4177 0
Results – basic reporting
Results – plain English summary