DementiaHOMESIDENCT03907748
Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia
A study testing Music Intervention and Reading Intervention in people with Dementia and Dementia, Vascular, run by Anglia Ruskin University at 5 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies
- What is being tested?
- Music Intervention and Reading Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 20 Nov 2019to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Germany1 site
University of Applied Sciences Würzburg-Schweinfurt
Würzburg, 97070
United Kingdom1 site
Anglia Ruskin University
Cambridge, Cambridgeshire, CB1 1PT
About this study
Official title: HOMESIDE: Home-based Family Caregiver-delivered Music and Reading Interventions for People Living With Dementia: A Randomised Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia, Mixed, Dementia Alzheimers, Behavioural and Psychiatric Symptoms of Dementia
- Being tested
- Music Intervention, Reading Intervention
- Keywords
- music therapy, music interventions, home-based interventions, Reading, dementia, care giver
- Medical subject headings
- Dementia, Dementia, Vascular, Lewy Body Disease, Mixed Dementias, Alzheimer Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music InterventionOther
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).
Reading InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Music Intervention |
| 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. Receives: Other: Reading Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured by the Montgomery Asberg Depression Rating Scale (MADRS). Scale scores range from 0-60, where higher scores indicate more severe depression.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start20 Nov 2019
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 864 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, Norwegian Academy of Music, University of Applied Sciences Würzburg-Schweinfurt, University School of Physical Education, Krakow, Poland, Alzheimer's Society, Methodist Homes for the Aged, Saffron Hall Trust, Cambridgeshire and Peterborough NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Felicity Baker, Professor, Study director, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907748
- Sponsor's protocol ID
- U4-10366
- Other IDs
- ACTRN12618001799246p, 462
- Acronym
- HOMESIDE
- Status last verified
- Feb 2022
- First submitted
- 3 Apr 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41120472Baker 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.
PubMed 38106552Pac 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.
PubMed 37226214Baker 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.
PubMed 31748300
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOMESIDE: Home-based Family Caregiver-delivered Music and Reading Interventions for People Living With Dementia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03907748
- Acronym / sponsor ID
- HOMESIDE / U4-10366
- Conditions
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia, Mixed, Dementia Alzheimers, Behavioural and Psychiatric Symptoms of Dementia
- Keywords
- music therapy, music interventions, home-based interventions, Reading, dementia, care giver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 864 participants (actual)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Collaborators
- University of Melbourne, Norwegian Academy of Music, University of Applied Sciences Würzburg-Schweinfurt, University School of Physical Education, Krakow, Poland, Alzheimer's Society, Methodist Homes for the Aged, Saffron Hall Trust, Cambridgeshire and Peterborough NHS Foundation Trust
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music Intervention | Experimental | Other: Music InterventionThe 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 | Other: Reading InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music InterventionAfter 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 | Music Intervention |
| Reading InterventionAfter 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. | Other | Reading Intervention |
Primary outcome
Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (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.
9 secondary outcomes
Change from baseline of depression in participants with dementia at post-intervention and 6-month follow-up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Derived from this study: PubMed 41120472Bukowska 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.
- Derived from this study: PubMed 38106552Baker 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.
- Derived from this study: PubMed 37226214Pac 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.
- Derived from this study: PubMed 31748300Baker 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felicity Baker, Professor study director
University of Melbourne
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Intervention and Reading Intervention in people with Dementia and Dementia, Vascular, run by Anglia Ruskin University at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, Germany, Norway, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up (time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03907748, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.