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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03907748




Registration number
NCT03907748
Ethics application status
Date submitted
3/04/2019
Date registered
9/04/2019

Titles & IDs
Public title
Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia
Scientific title
HOMESIDE: Home-based Family Caregiver-delivered Music and Reading Interventions for People Living With Dementia: A Randomised Controlled Trial
Secondary ID [1] 0 0
ACTRN12618001799246p
Secondary ID [2] 0 0
U4-10366
Universal Trial Number (UTN)
Trial acronym
HOMESIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 0 0
Dementia, Vascular 0 0
Dementia With Lewy Bodies 0 0
Dementia, Mixed 0 0
Dementia Alzheimers 0 0
Behavioural and Psychiatric Symptoms of Dementia 0 0
Depression 0 0
Quality of Life 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Mental Health 0 0 0 0
Other mental health disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Music Intervention
Other interventions - Reading Intervention

Experimental: Music Intervention - The music intervention will be provided to participant dyads (people with dementia and their cohabiting family caregivers) allocated to the first intervention. Caregivers will be trained to use the music intervention in three 2-hour training sessions with an intervention trainer (a music therapist). Training will take place at the dyad's home. The caregiver will then be asked to deliver the music intervention to the person with dementia at least 5x per week for 30 minutes.

Active comparator: Reading Intervention - The reading intervention will be provided to participant dyads (people with dementia and their cohabiting caregivers) allocated to the second intervention. Caregivers will be trained to use the reading intervention in three 2-hour training sessions with an intervention trainer. Training will take place at the dyad's home. The caregiver will then be asked to deliver the reading intervention to the person with dementia at least 5x per week for 30 minutes.

No intervention: Standard Care - Participant dyads (people with dementia and their cohabiting caregivers) allocated to the standard care group will not receive any training or be asked to deliver an intervention.


Other interventions: Music Intervention
After training, caregivers will deliver the music intervention to the person with dementia whom they care for. The music intervention will include: a) singing familiar/preferred music followed by discussions facilitated by the caregiver about any associated meanings or memories; b) movement to music (e.g. upper body and arms imitating familiar dance movements to music); c) instrument playing; and d) listening to familiar/preferred relaxing or enlivening music (dependent upon symptoms present in the moment). These methods are known to assist in emotion regulation and increase cognitive reserve (e.g. attention and perceptual-motor function).

Other interventions: Reading Intervention
After training, caregivers will deliver the reading intervention to the person with dementia whom they care for. The reading intervention will include: a) the caregiver reading aloud to the person they are caring for; b) the person with dementia reading aloud to their caregiver; and c) discussion of the text and personal responses. Strategies to engage the person with dementia and to create opportunities for meaningful dialogue will be provided, as well as guidance on selecting reading material that is accessible to the person's level of cognitive impairment.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up
Timepoint [1] 0 0
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary outcome [1] 0 0
Change from baseline of depression in participants with dementia at post-intervention and 6-month follow-up
Timepoint [1] 0 0
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary outcome [2] 0 0
Change from baseline of quality of life of participants with dementia at post-intervention and 6-month follow-up
Timepoint [2] 0 0
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary outcome [3] 0 0
Change from baseline of depression in caregiver participants at post-intervention and 6-month follow-up
Timepoint [3] 0 0
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary outcome [4] 0 0
Change from baseline of resilience in caregiver participants at post-intervention and 6-month follow-up
Timepoint [4] 0 0
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary outcome [5] 0 0
Change from baseline in caregiver competence of caregiver participants at post-intervention and 6-month follow-up
Timepoint [5] 0 0
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary outcome [6] 0 0
Change from baseline in quality of life of caregiver participants at post-intervention and 6-month follow-up
Timepoint [6] 0 0
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary outcome [7] 0 0
Change from baseline in quality of the relationship between caregiver and person with dementia at post-intervention and 6-month follow-up
Timepoint [7] 0 0
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary outcome [8] 0 0
Change from baseline in quality of adjusted life-years of caregiver and person with dementia at post-intervention and 6-month follow-up
Timepoint [8] 0 0
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary outcome [9] 0 0
Change from baseline in resource use of both caregiver and person with dementia (cost-effectiveness) at post-intervention and 6-month follow-up
Timepoint [9] 0 0
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)

Eligibility
Key inclusion criteria
* Dyads (cohabiting) who are close in relationship and where one member has a diagnosis of dementia according to ICD-10 criteria (Alzheimer's Disease [AD], Frontotemporal Dementia, Vascular Dementia [VD], Lewy Body Disease, or mixed dementia) as determined by a clinician experienced in diagnosing dementia. Close in relationship refers to a caregiver who may be a sibling, spouse, adult child, friend, niece or nephew or any person who has a close relationship to the person with dementia, that is, anyone who is not a formal paid caregiver.
* Dyads where the person with dementia has a Neuropsychiatric Inventory-Questionnaire (NPI-Q) Score of =6 (from a maximum score of 36)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Dyads where either or both the caregiver or person with dementia have significant hearing impairments that are not resolved through the use of a hearing aid device and limit their capacity to enjoy musical experiences
* There will be no further exclusions

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/12/2022
Sample size
Target
Accrual to date
Final
864
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3006 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Würzburg
Country [2] 0 0
Norway
State/province [2] 0 0
Oslo
Country [3] 0 0
Poland
State/province [3] 0 0
Kraków
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Cambridgeshire

Funding & Sponsors
Primary sponsor type
Other
Name
Anglia Ruskin University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Norwegian Academy of Music
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Applied Sciences Würzburg-Schweinfurt
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University School of Physical Education, Krakow, Poland
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Alzheimer's Society
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Methodist Homes for the Aged
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Saffron Hall Trust
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Cambridgeshire and Peterborough NHS Foundation Trust
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Felicity Baker, Professor
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
In accordance with the Australian Code for Responsible Conduct of Research (Universities Australia, 2018), all data will be retained for retrieval and re-use in future research where participant permission is granted. Data made available will include individual-level deidentified participant data, reports on adverse events, and deidentified interview transcripts.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Following project completion, de-identified anonymised data will be made available (with participant consent). According to the GDPR, the consortium have agreed for reused for 10 years after the project has been completed.
Available to whom?
Data will be made available on the Australian Data Archive https://ada.edu.au and listed on Research Australia's https://researchaustralia.org website to facilitate access for future research.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03907748