Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12618001799246p | Registry Identifier | Austrailian New Zealand Clinical Trials Registry | |
| 462 | Other Grant/Funding Number | Alzheimer's Society |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Melbourne | OTHER |
| Norwegian Academy of Music | OTHER |
| University of Applied Sciences Würzburg-Schweinfurt | UNKNOWN |
| University School of Physical Education, Krakow, Poland |
Not provided
Not provided
Not provided
Not provided
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.
This three-arm parallel-group randomised controlled trial will involve 495 couples (cohabiting caregivers and people with dementia) across 5 countries. Caregivers allocated to the music or reading intervention groups will be given three 2-hour training sessions in the allocated intervention. They will be asked to deliver the intervention to the person they are caring for 5x weekly for 3 months. Data will be collected prior to implementing the intervention, during the intervention (via diaries kept by the caregivers), after the last week of implementing the intervention and 3-months after implementing the intervention.
The investigators will explore whether caregiver-delivered music or reading activities improve behavioural and psychological symptoms for people living with dementia. The researchers will also seek to find out the impact on other aspects of both the person with dementia and their caregiver's quality of life and well being. Additionally, costs associated with the care of the person with dementia will be evaluated to determine cost-effectiveness of delivering a music intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Intervention | Experimental | 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. |
|
| Reading Intervention | Active Comparator | 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. |
|
| Standard Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Intervention | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of depression in participants with dementia at post-intervention and 6-month follow-up | Measured by the Montgomery Asberg Depression Rating Scale (MADRS). Scale scores range from 0-60, where higher scores indicate more severe depression. | baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention dosage throughout intervention | Measured using the tailored diary for caregivers to record the duration of music or reading intervention use, responses of the person with dementia and details of activities used. | Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week) |
| Caregivers' experiences of delivering the music and reading interventions |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Felicity Baker, Professor | University of Melbourne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Melbourne | Melbourne | 3006 | Australia | |||
| University of Applied Sciences Würzburg-Schweinfurt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41120472 | Derived | 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. | |
| 38106552 |
Not provided
Not provided
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.
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.
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.
Not provided
Not provided
| OTHER |
| Alzheimer's Society | OTHER |
| Methodist Homes for the Aged | OTHER |
| Saffron Hall Trust | UNKNOWN |
| Cambridgeshire and Peterborough NHS Foundation Trust | OTHER |
Participants (people with dementia and their cohabiting family caregivers) will be allocated to either (1) the music intervention group, (2) the reading intervention group or (3) the standard care group.
Not provided
Not provided
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.
|
| Reading Intervention | Other | 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. |
|
| Change from baseline of quality of life of participants with dementia at post-intervention and 6-month follow-up | Measured by the Quality of Life - Alzheimer's Disease (QoL-AD) scale. Scale scores range from 13-52, where higher scores indicate higher quality of life. | 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 | Measured by the Patient Health Questionnaire-9 (PHQ-9). Scale scores range from 0-27, where scores greater than 20 indicate severe depression. | 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 | Measured by the Resilience Scale-14 (RS-14). Scale scores range from 14-98, where higher scores indicate higher resilience. | 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 | Measured by the Short Sense of Competence Questionnaire (SSCQ). Scale scores range from 7-35, where higher scores indicate higher sense of competence. | baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
| Change from baseline in quality of life of caregiver participants at post-intervention and 6-month follow-up | Measured by the Assessment of Quality of Life-6D (AQOL-6D). | baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
| Change from baseline in quality of the relationship between caregiver and person with dementia at post-intervention and 6-month follow-up | Measured by the Quality of Caregiver-Patient Relationship (QCPR). Scale scores range from 14-70, where higher scores indicate a higher quality of relationship. | baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
| Change from baseline in quality of adjusted life-years of caregiver and person with dementia at post-intervention and 6-month follow-up | Measured by the EuroQoL Instrument (EQ-5D-5L). | baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
| Change from baseline in resource use of both caregiver and person with dementia (cost-effectiveness) at post-intervention and 6-month follow-up | Measured by the Resource Utilization in Dementia (RUD). | baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
Measured using post-intervention qualitative interviews with caregivers to capture descriptions of their experience of delivering the intervention and data to fine-tune the training, research design and the protocol. |
| 12-weeks (primary time point) |
| Caregivers' experiences and reactions to the music and reading intervention training sessions | Measured using a short questionnaire. | Post intervention training sessions at 1-week, 3-weeks, and 6-weeks |
| Caregivers' adherence to programme and ability to apply the learning from the training sessions in their day-to-day caring | Measured using the tailored diary for caregivers to record the duration of music or reading intervention use, responses of the person with dementia and details of activities used | Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week) |
| Change from baseline of cognition of participants with dementia at post-intervention to explore relationship between cognitive decline, behavioural and psychological symptoms of dementia, depression and response to different conditions | Measured using the Mini-Mental State Examination (MMSE). Scores Higher scores indicate better cognitive capacity with scores of 24-30 indicating no cognitive impairment; 19-23 indicating mild cognitive impairment; 10-18 indicating moderate cognitive impairment; and scores <10 indicating severe cognitive impairment. | baseline and 12-weeks (primary time-point, post-intervention) |
| Adverse events | Adverse events will be measured throughout the 12-week intervention period for all groups via fortnightly phone calls. Participants will be asked about any adverse events they may have experienced, including hospitalisations, unexpected GP appointments or negative responses to the interventions. | Phone calls at weeks 2, 4, 6, 8, 10, 12 |
| 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 |
| Baker 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. |
| 37226214 | Derived | Pac 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. |
| 31748300 | Derived | Baker 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. |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D015140 | Dementia, Vascular |
| D020961 | Lewy Body Disease |
| D000093902 | Mixed Dementias |
| D000544 | Alzheimer Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D024801 | Tauopathies |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided