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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 20 August 2018
Main ID:  ACTRN12617001513303
Date of registration: 27/10/2017
Prospective Registration: Yes
Primary sponsor: The University of Melbourne
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
Date of first enrolment: 4/05/2018
Target sample size: 180
Recruitment status: Recruiting
URL:  http://www.anzctr.org.au/ACTRN12617001513303.aspx
Study type:  Interventional
Study design:  Randomised controlled trial  Parallel
Phase:  Not Applicable
Countries of recruitment
Australia
Contacts
Name:     Dr Jeanette Tamplin
Address:  Music Therapy University of Melbourne 234 St Kilda Rd, Southbank, VIC 3006, Australia
Telephone: +61 3 8344 3003
Email: jeanette.tamplin@unimelb.edu.au
Affiliation: 
Name:     Dr Jeanette Tamplin
Address:  Music Therapy University of Melbourne 234 St Kilda Rd, Southbank, VIC 3006, Australia
Telephone: +61 3 8344 3003
Email: jeanette.tamplin@unimelb.edu.au
Affiliation: 
Key inclusion & exclusion criteria
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.

Exclusion criteria: Living in residential care at time of recruitment
Unable to hear at all (deafness)
Unable to speak English


Age minimum: 18 Years
Age maximum:
Gender: Both males and females
Health Condition(s) or Problem(s) studied
caregiver burden
dementia
Intervention(s)
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.
Primary Outcome(s)
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).
Secondary Outcome(s)
Anxiety in the participants with dementia is measured using the Rating Anxiety in Dementia Scale (RAID) (Shankar et al, 1999).
Caregiver burden is assessed in family caregivers via the Zarit Burden Scale (Zarit et al, 1980).
Caregiver depression will be assessed using the Patient Health Questionnaire–9 (PHQ-9) (Kroenke et al 2001) for family caregivers
Caregiver quality of life will be assessed using the Assessment of Quality of Life-8D (AQoL-8D) (Richardson et al 2014).
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).
Depression for participants with dementia will be assessed using the Cornell Scale for Depression in Dementia (CSDD) (Alexopoulos et al 1988).
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.
Social connectedness is measured for both people living with dementia and family caregivers using the Social Connectedness Scale (Lee & Robbins, 1995).
Secondary ID(s)
none
Source(s) of Monetary Support
NH&MRC
Secondary Sponsor(s)
n/a
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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