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Trial registered on ANZCTR


Registration number
ACTRN12618001799246p
Ethics application status
Submitted, not yet approved
Date submitted
29/10/2018
Date registered
5/11/2018
Date last updated
22/01/2019
Date data sharing statement initially provided
5/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Home-based family caregiver-delivered music Interventions for people living with dementia.
Scientific title
A HOME-based family caregiver-delivered music Intervention to manage behavioural and psychological symptoms of dementia: A Randomised Controlled Trial.
Secondary ID [1] 296154 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HOMESIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
behavioural symptoms of dementia 309754 0
depression 309755 0
psychological symptoms of dementia 310268 0
Lewy Body's Disease 310269 0
Condition category
Condition code
Neurological 308553 308553 0 0
Dementias
Neurological 308554 308554 0 0
Alzheimer's disease
Neurological 308555 308555 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Music Intervention (MI) will be provided to participant dyads allocated to the first intervention. Family caregivers (CGs) will receive a 2-hour home-based MI training session where a music therapist will instruct the CGs on methods and strategies for using music to assist the person living with dementia (PwD) to become calmer (if agitated) or more energised (if apathetic). CGs will be instructed on how to choose music and engage the PwD in effective and respectful discussions with the aim of evoking autobiographical memories and sharing meaningful experiences. Strategies to engage PwD and create opportunities for meaningful dialogue with the PwD will be provided, as well as training CGs to notice the PwD’s positive and negative responses to music. The activities to be taught comprise: a) singing familiar/preferred music followed by CG-facilitated discussions about the meaning of the songs for the dyad, the PwD, and significant others, and any associated memories; b) movement to music (e.g. upper body and arms imitating familiar dance movements to music) to assist in regulating arousal; and c) listening to familiar/preferred relaxing or enlivening music dependent upon behavioural and psychological symptoms of dementia (BPSD) present at the time to assist in regulating arousal. The PwD will not be present during the training session. Following training, the CG will try out some of the methods learned with the PwD while the music therapist is still present, and the music therapist will offer feedback and further guidance to enable the CG to experience the activities in action with immediate support from the music therapist. The session will take at least 60 minutes and up to 90 minutes and will continue until the CG feels confident to deliver the intervention unsupported. CGs are then instructed to deliver the MI at least 5x per week for approximately 30 mins over a 12-week period. At 3-weeks and 6-weeks post allocation, the MI trainer will return to the dyad’s home for a second and third training session to further extend CG knowledge and skills, and improve and monitor adherence to the protocol. These sessions will involve the MI trainer providing additional techniques for use within the MI program. These techniques will include how to combine gentle touch with singing, transitioning from dancing to relaxation, and further skill training in how to facilitate dialogue. Further, the trainer will observe the CG delivering the intervention with the PwD and the trainer will then provide additional feedback to help the CG hone his/her skills and increase the effectiveness of the intervention. Fortnightly phone conversations with CGs by those providing the MI training will be used to support the CG, check-in as to how they are progressing with the use of the MI and answer any questions they may have.


Intervention code [1] 312479 0
Treatment: Other
Comparator / control treatment
Reading Intervention (RI) will be provided to participant dyads allocated to the second intervention (comparator). Family caregivers will receive a 2-hour RI instruction session which aims to engage the PwD during and following the RI. The activities to be taught are based on RI methods commonly used with PwD including: a) CG reading aloud to PwD; b) PwD reading aloud to CG; and c) discussion of the text and personal responses. Strategies to engage PwD and create opportunities for meaningful dialogue with the PwD will be provided as well as guidance on selecting reading material accessible to the PwD’s level of cognitive impairment. CGs are then instructed to deliver RI at least 5x per week for 30 mins over 12-weeks. At 3-weeks and 6-weeks post allocation, the RI trainers will return to the dyad’s home for a second and third training session with the intention of further extending CG knowledge and skills and to improve and monitor intervention protocol adherence. These sessions will involve the RI trainer providing additional techniques for use within the RI program including suggesting additional types of reading material. Further, the trainer will observe the CG delivering the intervention with the PwD and the trainer will then provide additional feedback to help the CG hone his/her skills and increase the effectiveness of the intervention. Fortnightly phone conversations with CGs will be used to support the CG, check-in as to how they are progressing with the use of the RI, and answer any questions they may have about implementing the intervention.

Standard Care (control). Dyads randomly allocated to this condition will not be trained in either MI or RI but will be instructed to care for the PwD in their usual manner. For ethical reasons, those in the SC group will receive information about how to access local support when needed. Usual care means that CGs will receive no special instructions for how to manage the person they are caring for and so it is anticipated that CGs will continue to care for their family member in much the same way as they have been doing up until that point.
Control group
Active

Outcomes
Primary outcome [1] 307520 0
behavioural and psychological symptoms of participants living with dementia as assessed by changes in Neuropsychiatric Inventory Questionnaire
Timepoint [1] 307520 0
baseline, 12 weeks (primary time-point), and 6 months after intervention commencement
Secondary outcome [1] 352185 0
changes in levels of depression in people living with dementia as assessed by Montgomery Asberg Depression Rating Scale
Timepoint [1] 352185 0
baseline, 12 weeks and 6 months after intervention commencement
Secondary outcome [2] 352186 0
changes in quality of life in the participant living with dementia as assessed by the Quality of Life-Alzheimer's Disease
Timepoint [2] 352186 0
baseline, 12 weeks, and 6 months after intervention commencement
Secondary outcome [3] 352187 0
symptoms of depression in the family caregiver as assessed by the Patient Health Questionnaire-PHQ-9
Timepoint [3] 352187 0
baseline, 12 weeks, and 6 months after intervention commencement
Secondary outcome [4] 352188 0
changes in family caregiver resilience as measured by the Resilience Scale
Timepoint [4] 352188 0
baseline, 12 weeks, and 6 months after intervention commencement
Secondary outcome [5] 352189 0
Family Caregiver sense of competence in caregiving as measured by Sense of Competence Questionnaire Short Form
Timepoint [5] 352189 0
baseline, 12 weeks, and 6 months after intervention commencement
Secondary outcome [6] 352190 0
Quality of Life of family caregiver as assessed by the Assessment of Quality of Life-6D
Timepoint [6] 352190 0
baseline, 12 weeks, and 6 months after intervention commencement
Secondary outcome [7] 352191 0
changes in the quality of caregiver and person with dementia's relationship as assessed by the Quality of the Caregiver-Patient Relationship.
Timepoint [7] 352191 0
baseline, 12 weeks, and 6 months after intervention commencement
Secondary outcome [8] 352192 0
assessment of the quality of adjusted life-years of family caregiver and person living with dementia as assessed by the EuroQoL instrument
Timepoint [8] 352192 0
baseline, 12 weeks, and 6 months after intervention commencement
Secondary outcome [9] 352193 0
Assessment of resource use of both family caregiver and person living with dementia as measured by the Resource Utilization in Dementia.
Timepoint [9] 352193 0
baseline, 12 weeks, and 6 months after intervention commencement

Eligibility
Key inclusion criteria
1) dyads where one member of the dyad has a diagnosis of: dementia (Alzheimer’s Disease [AD], Frontotemporal Dementia, Vascular Dementia [VD], Lewy Body Disease, or mixed dementia)
2) people living with dementia
3) family caregivers of people living with dementia who are at least 18 years of age
4) family caregivers who are co-habitating with the person living with dementia who are providing primary care for the person with dementia for more than 5 hours per day, for at least 5 days per week.
5) dyads are living at home and not in supported residential care


Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
dyads where the person living with dementia is not cohabiting with the familycarer.
dyads where the family caregiver does not provide personal care for more than 5 hours per day for 5 days per week

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)
495 dyads will be randomised from 5 countries involved. To ensure allocation concealment, the randomisation list will be created and kept concealed at the central study office at The University of Melbourne
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated by an independent statistician and allocation will be carried out through a centralised randomisation service. A stratified block permuted randomisation will be used for each of the 5 countries involved in this trial (Australia, Norway, United Kingdom, Germany and Poland), so that treatment balance within country is achieved. Dyads who meet the inclusion criteria and none of the exclusion criteria will be randomised 1:1:1 into music intervention, reading intervention or standard care within country. Randomization will occur after the informed consent, eligibility, and baseline assessment are conducted. Dyads will be informed of their group allocation by post or email
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses of the main study will be performed on an intention-to-treat basis according to a prespecified statistical analysis plan. The primary outcome (NPI-Q severity total score) will be analysed using a constrained longitudinal data analysis (cLDA) model with response consisting of all scores (pre, post, and follow-up) and the model including factors representing condition, time, condition by time interaction, and country with the restriction of a common baseline mean score across conditions. The absolute difference between music intervention and Standard Care and Music Intervention and Reading Intervention in mean change from baseline will be estimated (including 95% confidence interval) at 12 weeks (primary time point). A hierarchical fixed sequence testing procedure will allow testing of music versus reading at 12 weeks at 5% if the comparison of music versus standard care at 12 weeks has p<0.05. Trend over time within conditions will be assessed using contrasts (e.g. linear). Sensitivity analyses will consist of a model adjusted for confounders (e.g. forms of dementia and gender). The cLDA model provides valid inference if the missing data mechanism is missing at random. The sensitivity of the results to this missing data assumption will be investigated under the “missing not at random missing data assumption” using a pattern-mixture model. In addition to the intention-to-treat effect we will evaluate the effect in those who comply with their allocated treatment (the complier average causal effect) using instrumental variable regression based on the collected dosage data. Similar analyses (cLDA) will be applied to the secondary outcomes for people living with dementia and family caregivers. Time to transition (days) will be analysed using Cox proportional hazards regression. Consistency of the intervention effect across subgroups (gender of the people living with dementia and caregivers, forms of dementia, country) will be assessed by means of test of interaction.

Cost-effectiveness analysis in a societal perspective will be performed separately for each country using the health-related quality of life data and associated costs for delivering the music interventions, health care resource use costs, and productivity loss. We will estimate the quality-adjusted life years (QALYs) gained and Euros spent per unit of improvement in people with dementia and caregivers QALYs.

Recruitment
Recruitment status
Not yet recruiting
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)
VIC
Recruitment outside Australia
Country [1] 20859 0
United Kingdom
State/province [1] 20859 0
Cambridgeshire
Country [2] 20860 0
Germany
State/province [2] 20860 0
Wurzburg
Country [3] 20861 0
Poland
State/province [3] 20861 0
Krakow, Gdansk
Country [4] 20862 0
Norway
State/province [4] 20862 0
Oslo

Funding & Sponsors
Funding source category [1] 300745 0
Government body
Name [1] 300745 0
National Health and Medical Research Council
Address [1] 300745 0
GPO Box 1421 Canberra ACT 2601
Country [1] 300745 0
Australia
Funding source category [2] 300927 0
Government body
Name [2] 300927 0
Norwegian Research Council
Address [2] 300927 0
Drammensveien 288, 0283 Oslo, Norway
Country [2] 300927 0
Norway
Funding source category [3] 300928 0
Charities/Societies/Foundations
Name [3] 300928 0
Alzheimer's Society, UK
Address [3] 300928 0
43-44 Crutched Friars, London, EC3N, UK
Country [3] 300928 0
United Kingdom
Funding source category [4] 300929 0
Government body
Name [4] 300929 0
Federal Ministry of Education and Research
Address [4] 300929 0
Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR)
German Aerospace Center
DLR Project Management Agency | Department Health | Division International Cooperations in Health Research
Postal Address: Heinrich-Konen-Straße 1 | 53227 Bonn | Germany
Country [4] 300929 0
Germany
Funding source category [5] 300930 0
Government body
Name [5] 300930 0
National Centre for Research and Development (NCBR)
Address [5] 300930 0
Nowogrodzka 47A, 00-695 Warszawa, Poland
Country [5] 300930 0
Poland
Primary sponsor type
University
Name
The University of Melbourne
Address
Faculty of VCA and MCM
University of Melbourne
234 St Kilda Road VIC 3006
Country
Australia
Secondary sponsor category [1] 300279 0
University
Name [1] 300279 0
Anglia Ruskin University
Address [1] 300279 0
Cambridge Campus, East Rd, Cambridge CB1 1PT, UK
Country [1] 300279 0
United Kingdom
Secondary sponsor category [2] 300280 0
University
Name [2] 300280 0
Norwegian Academy of Music
Address [2] 300280 0
Slemdalsveien 11, 0363 Oslo, Norway
Country [2] 300280 0
Norway
Secondary sponsor category [3] 300281 0
University
Name [3] 300281 0
The University of Applied Sciences Würzburg-Schweinfurt
Address [3] 300281 0
Münzstraße 12 97070 Würzburg
Country [3] 300281 0
Germany
Secondary sponsor category [4] 300282 0
University
Name [4] 300282 0
THe University School of Physical Education in Krakow
Address [4] 300282 0
al. Jana Pawla II 78, 31-571 Kraków, Poland
Country [4] 300282 0
Poland

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301524 0
Medicine and Dentistry Human Ethics sub-committee (The University of Melbourne)
Ethics committee address [1] 301524 0
Medicine and Dentistry HESC The University of Melbourne Parkville VIC 3010
Ethics committee country [1] 301524 0
Australia
Date submitted for ethics approval [1] 301524 0
28/10/2018
Approval date [1] 301524 0
Ethics approval number [1] 301524 0

Summary
Brief summary
This project is investigating how a home-based family caregiver directed music intervention impacts the behavioural and psychological symptoms of dementia, the levels of depression in person living with dementia and their family caregiver, and their quality of life. It is part of larger international study involving European investigators. The project will study the impact of music on wellbeing for 198 older Australians (99 dyads) over a 6-month period, with a total sample size of 495 dyads across the 5 countries. Each dyad will be randomly assigned to either a music intervention, a reading intervention (active control) or standard care. Over the 6-month period, we will be collecting a range of data that will help us understand whether music has or has an effect on participants' mood, quality of life, and symptoms of dementia. Moreover, we will be asking carers to complete measures about their own wellbeing to help us understand the impact of the music intervention has on caregivers' wellbeing and burden.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87282 0
Prof Felicity Baker
Address 87282 0
Faculty of Fine Arts and Music
The University of Melbourne
234 St Kilda Rd, Southbank
Melbourne Victoria 3006
Country 87282 0
Australia
Phone 87282 0
+61 402 172 795
Fax 87282 0
Email 87282 0
felicity.baker@unimelb.edu.au
Contact person for public queries
Name 87283 0
Prof Felicity Baker
Address 87283 0
Faculty of Fine Arts and Music
The University of Melbourne
234 St Kilda Rd, Southbank
Melbourne Victoria 3006
Country 87283 0
Australia
Phone 87283 0
+61 402 172 795
Fax 87283 0
Email 87283 0
felicity.baker@unimelb.edu.au
Contact person for scientific queries
Name 87284 0
Prof Felicity Baker
Address 87284 0
Faculty of Fine Arts and Music
The University of Melbourne
234 St Kilda Rd, Southbank
Melbourne Victoria 3006
Country 87284 0
Australia
Phone 87284 0
+61 402 172 795
Fax 87284 0
Email 87284 0
felicity.baker@unimelb.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
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Attachments/websites
Type [1] 23 0
URL/details/comments [1] 23 0
Attachment [1] 23 0
Summary results
Not applicable