Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia
HOMESIDE
HOMESIDE: Home-based Family Caregiver-delivered Music and Reading Interventions for People Living With Dementia: A Randomised Controlled Trial
3 other identifiers
interventional
864
5 countries
5
Brief Summary
This international study evaluates the impact of home-based caregiver-delivered music and reading interventions for people with dementia. The project aims to address the need for improved informal dementia care by training family caregivers to utilise a music or reading intervention with the person they are caring for. The interventions aim to decrease behavioural and psychological symptoms of dementia as well as improve quality of life and well being of both people living with dementia and their caregivers. Participants will be allocated into a music intervention group, a reading intervention group or standard care group. In addition, the researchers will seek to determine the cost-effectiveness of using the music intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedStudy Start
First participant enrolled
November 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2022
CompletedFebruary 9, 2023
February 1, 2022
3.1 years
April 3, 2019
February 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up
Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q). Severity scores range from 0-36, where higher scores indicate more severe behavioural and psychological symptoms of dementia. Distress scores range from 0-60, where higher values represent higher levels of distress due to symptoms.
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary Outcomes (9)
Change from baseline of depression in participants with dementia at post-intervention and 6-month follow-up
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline of quality of life of participants with dementia at post-intervention and 6-month follow-up
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline of depression in caregiver participants at post-intervention and 6-month follow-up
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline of resilience in caregiver participants at post-intervention and 6-month follow-up
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline in caregiver competence of caregiver participants at post-intervention and 6-month follow-up
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
- +4 more secondary outcomes
Other Outcomes (6)
Intervention dosage throughout intervention
Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week)
Caregivers' experiences of delivering the music and reading interventions
12-weeks (primary time point)
Caregivers' experiences and reactions to the music and reading intervention training sessions
Post intervention training sessions at 1-week, 3-weeks, and 6-weeks
- +3 more other outcomes
Study Arms (3)
Music Intervention
EXPERIMENTALThe 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.
Reading Intervention
ACTIVE COMPARATORThe 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.
Standard Care
NO INTERVENTIONParticipant 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.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anglia Ruskin Universitylead
- University of Melbournecollaborator
- Norwegian Academy of Musiccollaborator
- University of Applied Sciences Würzburg-Schweinfurtcollaborator
- University School of Physical Education, Krakow, Polandcollaborator
- Alzheimer's Societycollaborator
- Methodist Homes for the Agedcollaborator
- Saffron Hall Trustcollaborator
- Cambridgeshire and Peterborough NHS Foundation Trustcollaborator
Study Sites (5)
The University of Melbourne
Melbourne, 3006, Australia
University of Applied Sciences Würzburg-Schweinfurt
Würzburg, 97070, Germany
Norwegian Academy of Music
Oslo, 0302, Norway
University of Physical Education in Krakow
Krakow, Poland
Anglia Ruskin University
Cambridge, Cambridgeshire, CB1 1PT, United Kingdom
Related Publications (4)
Bukowska AA, Janus E, Soo VP, Smrokowska-Reichmann A, Hsu MH, Stensaeth KA, Odell-Miller H, Tamplin J, Wosch T, Sousa TV, Lamb KE, Braat S, Baker FA. Relationship between dementia diagnostic characteristics and severity of depressive symptoms in a cross-sectional analysis of HOMESIDE baseline data. Sci Rep. 2025 Oct 21;15(1):36643. doi: 10.1038/s41598-025-20385-z.
PMID: 41120472DERIVEDBaker FA, Pac Soo V, Bloska J, Blauth L, Bukowska AA, Flynn L, Hsu MH, Janus E, Johansson K, Kvamme T, Lautenschlager N, Miller H, Pool J, Smrokowska-Reichmann A, Stensaeth K, Teggelove K, Warnke S, Wosch T, Odell-Miller H, Lamb K, Braat S, Sousa TV, Tamplin J. Home-based family caregiver-delivered music and reading interventions for people living with dementia (HOMESIDE trial): an international randomised controlled trial. EClinicalMedicine. 2023 Oct 2;65:102224. doi: 10.1016/j.eclinm.2023.102224. eCollection 2023 Nov.
PMID: 38106552DERIVEDPac Soo V, Baker FA, Sousa TV, Odell-Miller H, Stensaeth K, Wosch T, Bukowska AA, Tamplin J, Lautenschlager N, Braat S, Lamb KE. Statistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia. Trials. 2023 May 8;24(1):316. doi: 10.1186/s13063-023-07327-8.
PMID: 37226214DERIVEDBaker FA, Bloska J, Braat S, Bukowska A, Clark I, Hsu MH, Kvamme T, Lautenschlager N, Lee YC, Smrokowska-Reichmann A, Sousa TV, Stensaeth KA, Tamplin J, Wosch T, Odell-Miller H. HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial. BMJ Open. 2019 Nov 19;9(11):e031332. doi: 10.1136/bmjopen-2019-031332.
PMID: 31748300DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Felicity Baker, Professor
University of Melbourne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome measures will be collected by researchers who are not aware of the whether the participants' are allocated to the music, reading or standard care groups. The participants will be reminded not to reveal the group they are in to the person collecting the data. The participants themselves cannot be blinded due to the active nature of the intervention.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 9, 2019
Study Start
November 20, 2019
Primary Completion
December 23, 2022
Study Completion
December 23, 2022
Last Updated
February 9, 2023
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 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.
- Access Criteria
- 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.
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.