Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001513303
Ethics application status
Approved
Date submitted
23/10/2017
Date registered
27/10/2017
Date last updated
18/07/2019
Date data sharing statement initially provided
18/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Remini-Sing: Therapeutic choirs to improve wellbeing and relationship quality for community dwelling people with dementia and their family caregivers
Scientific title
Remini-Sing: Therapeutic choirs to improve wellbeing and relationship quality for community dwelling people with dementia and their family caregivers
Secondary ID [1] 293179 0
none
Universal Trial Number (UTN)
n/a
Trial acronym
n/a
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
dementia 305178 0
caregiver burden 305179 0
Condition category
Condition code
Neurological 304495 304495 0 0
Dementias
Mental Health 304496 304496 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the music therapy intervention group 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 a Registered Music Therapist in a community venue (ie. community hall, day centre). Music therapist will receive training in how to deliver the intervention protocol (the therapeutic choir sessions) to ensure standardisation of the intervention. An intervention protocol has been developed for this training. This training includes strategies for how to provide cues and modify songs and musical activities to maximise engagement for people with dementia and also their family caregivers. It will also focus on strategies for managing safety issues and negative responses to the intervention.

The intervention also includes provision of education to participants in the intervention group 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 with tips and examples for how music can be used to manage behaviour and modify mood. The therapist will check in with caregivers regularly throughout the intervention and provide feedback and suggestions for how to use music therapeutically at home. There is no minimum requirement for participants to use the home music program, rather we will monitor the amount of home music use via a diary completed at each weekly choir session. Attendance logs will also be completed at each weekly choir session to monitor adherence to the intervention.
Intervention code [1] 299437 0
Treatment: Other
Comparator / control treatment
Participants randomised to the wait-listed control group will receive usual care only. Usual care for this study is defined as the usual daily activities of participants without the addition of therapeutic choir participation.
Control participants will be able to join a therapeutic choir following completion of their final assessment at week 21.
Control group
Active

Outcomes
Primary outcome [1] 303733 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] 303733 0
Relationship quality is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [1] 339990 0
Depression for participants with dementia will be assessed using the Cornell Scale for Depression in Dementia (CSDD) (Alexopoulos et al 1988).
Timepoint [1] 339990 0
PWD depression is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [2] 339991 0
Anxiety in the participants with dementia is measured using the Rating Anxiety in Dementia Scale (RAID) (Shankar et al, 1999).
Timepoint [2] 339991 0
Anxiety is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [3] 339992 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 [3] 339992 0
Quality of life is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [4] 339993 0
Social connectedness is measured for both people living with dementia and family caregivers using the Social Connectedness Scale (Lee & Robbins, 1995).
Timepoint [4] 339993 0
Social connectedness is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [5] 339994 0
Caregiver burden is assessed in family caregivers via the Zarit Burden Scale (Zarit et al, 1980).
Timepoint [5] 339994 0
Caregiver burden is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [6] 339995 0
Cost-effectiveness of intervention will be assessed by calculating difference between cost of the intervention and costs incurred from medication use and health services use (PBS & MBS records) as well as participant out-of-pocket costs. We will also examine economic benefit via the calculation of quality adjusted life years (QALYS).
Timepoint [6] 339995 0
Quality of life measures used for the calculation of quality adjusted life years are collected at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21). We will also extract data on medication use and health services use over the intervention period for all participants at the end of the study.
Secondary outcome [7] 340136 0
Caregiver depression will be assessed using the Patient Health Questionnaire–9 (PHQ-9) (Kroenke et al 2001) for family caregivers
Timepoint [7] 340136 0
Caregiver depression is assessed at baseline, midpoint (week 11), and following completion of 20 choir sessions (week 21).
Secondary outcome [8] 340137 0
Caregiver quality of life will be assessed using the Assessment of Quality of Life-8D (AQoL-8D) (Richardson et al 2014).
Timepoint [8] 340137 0
Caregiver quality of life is assessed at baseline, midpoint (week 11), and 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 the project.
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?
Yes
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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using sequentially numbered, sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequences will be generated for each site to ensure participants from each site are equally and randomly allocated to treatment and control groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data analysis: Analysis of covariance using baseline measures as covariates is planned for all outcome measures to determine any differences between the music intervention group and the waitlisted control groups. All analyses will be conducted according to intention-to-treat principles, meaning that all available data will analysed as allocated.

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. Using the net benefit approach, monetary values of incremental effects and incremental costs will be combined, and net benefit derived. This approach allows costs and outcomes to be considered on the same monetary scale, taking account of sampling uncertainty and adjusting for baseline covariates and clustering.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/01/2018
Actual
4/05/2018
Date of last participant enrolment
Anticipated
1/10/2018
Actual
5/08/2018
Date of last data collection
Anticipated
17/12/2018
Actual
26/02/2019
Sample size
Target
180
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
TAS,VIC

Funding & Sponsors
Funding source category [1] 297809 0
Government body
Name [1] 297809 0
NH&MRC
Country [1] 297809 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 296851 0
None
Name [1] 296851 0
n/a
Address [1] 296851 0
n/a
Country [1] 296851 0
Other collaborator category [1] 279777 0
Other Collaborative groups
Name [1] 279777 0
Uniting AgeWell
Address [1] 279777 0
Level 6, 130 Little Collins Street, Melbourne VIC 3000
Country [1] 279777 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298866 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 298866 0
Ethics committee country [1] 298866 0
Australia
Date submitted for ethics approval [1] 298866 0
05/06/2017
Approval date [1] 298866 0
26/07/2017
Ethics approval number [1] 298866 0
1749728

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

Contacts
Principal investigator
Name 78486 0
Dr Jeanette Tamplin
Address 78486 0
Music Therapy
University of Melbourne
234 St Kilda Rd,
Southbank, VIC 3006
Country 78486 0
Australia
Phone 78486 0
+61 3 8344 3003
Fax 78486 0
Email 78486 0
[email protected]
Contact person for public queries
Name 78487 0
Jeanette Tamplin
Address 78487 0
Music Therapy
University of Melbourne
234 St Kilda Rd,
Southbank, VIC 3006
Country 78487 0
Australia
Phone 78487 0
+61 3 8344 3003
Fax 78487 0
Email 78487 0
[email protected]
Contact person for scientific queries
Name 78488 0
Jeanette Tamplin
Address 78488 0
Music Therapy
University of Melbourne
234 St Kilda Rd,
Southbank, VIC 3006
Country 78488 0
Australia
Phone 78488 0
+61 3 8344 3003
Fax 78488 0
Email 78488 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
No ethics consent was sought from participants to make data available.


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
SourceTitleYear of PublicationDOI
EmbasePilot Randomised Evaluation of Singing in Dementia (PRESIDE): protocol for a two-arm, parallel-group randomised controlled feasibility study with waiting-list control.2021https://dx.doi.org/10.1186/s40814-020-00759-y
N.B. These documents automatically identified may not have been verified by the study sponsor.