Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001059257
Ethics application status
Approved
Date submitted
21/06/2018
Date registered
25/06/2018
Date last updated
16/07/2019
Date data sharing statement initially provided
16/07/2019
Date results provided
16/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot feasibility trial examining therapeutic choirs designed to improve wellbeing and relationship quality for community-dwelling people with dementia and their family caregivers
Scientific title
A pilot feasibility trial examining therapeutic choirs designed to improve wellbeing and relationship quality for community-dwelling people with dementia and their family caregivers
Secondary ID [1] 295271 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 308450 0
caregiver burden 308451 0
Condition category
Condition code
Neurological 307431 307431 0 0
Dementias
Mental Health 307432 307432 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend 20 weekly 2-hour choir sessions consisting of singing and social interaction. 90 minutes of singing activities (vocal warm-ups, participant requested songs, round singing, and simple part singing) will be followed by 30 minutes for social interaction over refreshments. The intervention will be facilitated by 2 Registered Music Therapists in a public hospital. The music therapists will provide cues and modify songs and musical activities to maximise engagement for people with dementia and also their family caregivers. They will also manage safety issues and negative responses to the intervention.

The intervention also includes provision of education to participants on how to use their own music therapeutically at home (to promote relaxation and reminiscence) and recordings of songs from choir sessions to use as desired. This education will be provided in the form of written handouts to caregivers (designed specifically for this study) with tips and examples for how music can be used to manage behaviour and modify mood. Handouts will given out once at the start of the intervention period. The therapist will check in with caregivers regularly throughout the intervention and provide feedback and suggestions for how to use music therapeutically at home. Attendance logs will also be completed at each weekly choir session to monitor adherence to the intervention.
Intervention code [1] 301606 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306399 0
Relationship quality between people living with dementia (PwD) and their family caregivers (FCG) as measured by the Quality of Caregiver and Patient Relationship scale (QCPR) (Spruytte et al 2002).
Timepoint [1] 306399 0
Relationship quality is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21 - primary endpoint).
Secondary outcome [1] 348382 0
Anxiety in the participants with dementia is measured using the Rating Anxiety in Dementia Scale (RAID) (Shankar et al, 1999).
Timepoint [1] 348382 0
Anxiety is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [2] 348383 0
Quality of life for participants with dementia will be assessed using the Quality of Life-Alzheimer's Disease (QOL-AD) (Logsdon et al 1999) for people living with dementia.
Timepoint [2] 348383 0
Quality of life is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [3] 348384 0
Apathy in the participants with dementia is measured using the Apathy Evaluation Scale (Marin et al. 1991).
Timepoint [3] 348384 0
Apathy is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [4] 348385 0
Agitation in the participants with dementia is measured using the Cohen-Mansfield Agitation Inventory – Short Form (Werner et al. 1994).
Timepoint [4] 348385 0
Agitation is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [5] 348386 0
Caregiver life satisfaction is measured using the Satisfaction with Life Scale (Diener et al. 1985).
Timepoint [5] 348386 0
Caregiver life satisfaction is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [6] 348387 0
Caregiver flourishing will be assessed using the Flourishing Scale (Diener et al 2010)
Timepoint [6] 348387 0
Caregiver flourishing is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [7] 348388 0
Caregiver depression will be assessed using the Patient Health Questionnaire–9 (PHQ-9) (Kroenke et al 2001).
Timepoint [7] 348388 0
Caregiver depression is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [8] 348389 0
Caregiver attitude towards caregiving will be assessed using the Positive Aspects of Caregiving Questionnaire (Boerner et al. 2004).
Timepoint [8] 348389 0
Caregiver attitude towards caregiving is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [9] 348390 0
Qualitative interviews with participants to examine participant's thoughts, feelings, and experiences of the intervention and assessments.
Interviews will be conducted with each PwD/FCG dyad and audio recorded for transcription.
Interview data will be analysed using thematic analysis.
Timepoint [9] 348390 0
Qualitative interviews will be conducted following completion of 20 choir sessions (week 21).

Eligibility
Key inclusion criteria
Community-dwelling people living with dementia (PwD) and their co-residing family caregivers (FCG) will be eligible for this feasibility trial.
Both PwD and FCG participants must have functional hearing and speak English.
For PwD, inclusion criteria are: aged at least 60 years and a confirmed diagnosis of dementia, OR probable dementia (i.e. a cognitive impairment level of 12–24 on the Mini Mental State Exam OR features consistent with Alzheimer’s type dementia as per DSM-V.
For FCG, inclusion criteria include age equal or greater than 18 years and either a spouse/partner, family member (eg. daughter or son), or close friend.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Living in residential care at time of recruitment
Unable to hear at all (deafness)
Unable to speak English

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)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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
Recruitment, participation and completion rates will be recorded and presented as percentages. Quantitative data will be summarized as mean (standard deviation) and analyzed using repeated measures analysis of variance and paired sample t-tests using a significance level of 0.05. Appropriateness of outcome measures will be determined by examining response and completion rates and interview responses. Effect size calculations on score changes over time on the outcome measures will also be analyzed to ascertain whether the measures were sensitive to change.
Qualitative data will be analysed using inductive thematic analysis. Intervention acceptability will be determined by examining completion rates and interview comments.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/04/2016
Date of last participant enrolment
Anticipated
Actual
17/08/2016
Date of last data collection
Anticipated
Actual
3/04/2017
Sample size
Target
15
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11202 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 23064 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 299856 0
Government body
Name [1] 299856 0
National Health and Medical Research Council
Country [1] 299856 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 299210 0
None
Name [1] 299210 0
Address [1] 299210 0
Country [1] 299210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300735 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 300735 0
Ethics committee country [1] 300735 0
Australia
Date submitted for ethics approval [1] 300735 0
10/11/2015
Approval date [1] 300735 0
18/03/2016
Ethics approval number [1] 300735 0
HREC/15/Austin/445

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

Contacts
Principal investigator
Name 84638 0
Dr Jeanette Tamplin
Address 84638 0
Music Therapy
The University of Melbourne
234 St Kilda Road
Southbank, 3006, VIC
Country 84638 0
Australia
Phone 84638 0
+61 3 83443003
Fax 84638 0
Email 84638 0
[email protected]
Contact person for public queries
Name 84639 0
Jeanette Tamplin
Address 84639 0
Music Therapy
The University of Melbourne
234 St Kilda Road
Southbank, 3006, VIC
Country 84639 0
Australia
Phone 84639 0
+61 3 83443003
Fax 84639 0
Email 84639 0
[email protected]
Contact person for scientific queries
Name 84640 0
Jeanette Tamplin
Address 84640 0
Music Therapy
The University of Melbourne
234 St Kilda Road
Southbank, 3006, VIC
Country 84640 0
Australia
Phone 84640 0
+61 3 83443003
Fax 84640 0
Email 84640 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
This was a small pilot study testing feasibility of measures only.


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.