Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000005651
Ethics application status
Approved
Date submitted
16/08/2022
Date registered
9/01/2023
Date last updated
9/01/2023
Date data sharing statement initially provided
9/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acceptability, feasibility, and effectiveness of a choir for enhancing quality of life in people diagnosed with dementia and their caregivers
Scientific title
Acceptability, feasibility, and effectiveness of a choir for enhancing quality of life in people diagnosed with dementia and their caregivers
Secondary ID [1] 307797 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementias 327373 0
Depression 327374 0
Condition category
Condition code
Neurological 324495 324495 0 0
Dementias
Mental Health 324496 324496 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weekly community choir rehearsals, during school terms, for people living with dementia and their carers. The choir is run by a choral conductor at Bulimba Community Centre. The choir meets in person at the community centre. The choir rehearsals run for 2 hours and include morning tea. Attendance is monitored each week and noted down on an attendance checklist. Volunteer "choir buddies" help to provide vocal support, social support, and organise morning tea.

The choir rehearsals involve vocal warm up exercises such as breathing exercises, tongue twisters, lip trills, and scale exercises. After the warm-up the choir will learn new songs. The songs will be broken down into sections and sung on repeat to practice. Sometimes the conductor will focus on learning the lyrics and at other times hitting the right notes. Participants are also taught how to follow the conductor's cues. Some of the songs will also involve singing in rounds. At the end of the rehearsal the choir will be able to sing a couple of songs all the way through. They will revisit songs they have learnt in future weeks. The choir also has a few performances through the year.

The research study will be conducted during the first year of the members participating in the choir.
Intervention code [1] 324256 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332324 0
Quality of Life - Quality of Life in Alzheimer's Disease (for people with dementia) + single item visual analogue scale (for family member carers)
Timepoint [1] 332324 0
Time 1 (0-3 months post-intervention commencement) + Time 2 (6-8 months post Time 1)
Primary outcome [2] 332325 0
Geriatric Depression Scale - 5 item version (for people with dementia and family member carers)
Timepoint [2] 332325 0
Time 1 (0-3 months post-intervention commencement) + Time 2 (6-8 months post Time 1)
Primary outcome [3] 332326 0
UCLA 3 item Loneliness Scale (for people with dementia and family member carers)
Timepoint [3] 332326 0
Time 1 (0-3 months post-intervention commencement) + Time 2 (6-8 months post Time 1)
Secondary outcome [1] 413035 0
Canterbury Wellbeing Scale (for people with dementia and family member carers)
Timepoint [1] 413035 0
Time 1 (0-3 months post-intervention commencement) + Time 2 (6-8 months post Time 1)
Secondary outcome [2] 413036 0
Carer Burden assessed using Zarit Burden Interview (for family member carers only)
Timepoint [2] 413036 0
Time 1 (0-3 months post-intervention commencement) + Time 2 (6-8 months post Time 1)

Eligibility
Key inclusion criteria
Participating in the Sing Sing Sing choir at Bulimba Community Centre (i.e., people living with dementia and their caregivers)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If unable to provide consent or understand questions due to severe cognitive impairment

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
Safety/efficacy
Statistical methods / analysis
Repeated measures T-test - n = 36 for .90 power to identify a moderate effect size of d = 0.5

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/09/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
25/09/2023
Actual
Sample size
Target
36
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 38292 0
4171 - Bulimba

Funding & Sponsors
Funding source category [1] 312066 0
University
Name [1] 312066 0
University of Queensland
Country [1] 312066 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Attn: Prof Genevieve Dingle
School of Psychology
McElwain Building (24A)
The University of Queensland
St Lucia campus, QLD, 4072
Country
Australia
Secondary sponsor category [1] 313572 0
None
Name [1] 313572 0
Address [1] 313572 0
Country [1] 313572 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311476 0
University of Queensland Human Research Ethics
Ethics committee address [1] 311476 0
Ethics committee country [1] 311476 0
Australia
Date submitted for ethics approval [1] 311476 0
20/07/2022
Approval date [1] 311476 0
17/08/2022
Ethics approval number [1] 311476 0
2022/HE001327

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

Contacts
Principal investigator
Name 121230 0
Prof Genevieve Dingle
Address 121230 0
School of Psychology McElwain Building (24A) University of Queensland St Lucia QLD 4072
Country 121230 0
Australia
Phone 121230 0
+61 7 3365 7295
Fax 121230 0
Email 121230 0
[email protected]
Contact person for public queries
Name 121231 0
Genevieve Dingle
Address 121231 0
School of Psychology McElwain Building (24A) University of Queensland St Lucia QLD 4072
Country 121231 0
Australia
Phone 121231 0
+61 7 3365 7295
Fax 121231 0
Email 121231 0
[email protected]
Contact person for scientific queries
Name 121232 0
Genevieve Dingle
Address 121232 0
School of Psychology McElwain Building (24A) University of Queensland St Lucia QLD 4072
Country 121232 0
Australia
Phone 121232 0
+61 7 3365 7295
Fax 121232 0
Email 121232 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?
The final cleaned data set with all de-identified individual participant data collected during the trial or a subset that is relevant to the data request.
When will data be available (start and end dates)?
Data available after publication of main results until 5 years post-publication
Available to whom?
Other researchers by request
Available for what types of analyses?
Reviews with meta analyses
How or where can data be obtained?
Data on the UQ Research Data Management system will be made available by emailing the principal investigator: [email protected]


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.