Benefits of Personalised Music in Dementia - a Feasibility Study
Recruiting
Observational Study
Dementia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Any
Study type
Observational
Participants needed
1,080 (estimated)
Sponsor
Music for my Mind · Other
Who this trial is looking for
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There is growing evidence for the benefits of music for individuals living with dementia but there has been limited research looking specifically at personalised music. Methodologies have not yet been developed to generate and play personalised music playlists quickly and cost effectively. The research team proposes a feasibility study to develop effective methodologies for:
i. efficient creation…
There is growing evidence for the benefits of music for individuals living with dementia but there has been limited research looking specifically at personalised music. Methodologies have not yet been developed to generate and play personalised music playlists quickly and cost effectively. The research team proposes a feasibility study to develop effective methodologies for:
i. efficient creation and delivery of personalised playlists for people with mild to moderate dementia in care homes; and
ii. assessing their responses to this music.
A long-list of personalised music (about 100 tracks) will be created by asking residents and their carers about the resident's musical tastes and background (particularly from their teenage years). A refined personalised playlist (of 10-20 tracks) will be created by playing excerpts from these tracks to the resident and gauging their responses including through direct feedback from the resident and their carer(s) plus observations of changes in facial expression, together with directly observed movements of hands, feet and/ or head, and changes in pulse rate (a monitor worn on the wrist to measure movement and pulse and the investigators will ask to film sessions). Care home staff and informal carers will use these playlists within the residents' care and the research team will use feedback from residents and carers to assess responses and explore whether factors such as the timing of listening or delivery methodology appear to affect the resident's well-being over time.
The findings from this study will be used to develop automated approaches to playlist creation (e.g. an App) and to inform further feasibility studies to: test and refine methodologies for use with participants with more advanced dementia; and explore more systematically the benefits of personalised music and factors that affect this, ultimately to inform the design of a subsequent larger scale intervention study.
Two substantial amendments were approved to this existing feasibility study on October 23, 2020. The two substantial amendments are:
1. To extend the main study to include participants who may lack capacity to consent.
2. A sub-study using fMRI to explore the mechanisms underlying reported beneficial effects of personalised music listening on behavioural and psychological symptoms in people living with dementia.
A further amendment was approved in January 2021, to recruit 1000 families affected by dementia, living at home or in the community, to use our recently developed WebApp to create a personalised playlist for their loved one living with dementia and provide their perceptions of how the music has impacted the well-being of the person with dementia.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
A care home meeting all of the following criteria will be eligible to join the feasibility studies:
* Is located in South East England;
* Has at least 5 residents who care home staff estimate to be eligible for the studies;
* Agrees to identify a suitable space for personalised…
Inclusion Criteria:
A care home meeting all of the following criteria will be eligible to join the feasibility studies:
* Is located in South East England;
* Has at least 5 residents who care home staff estimate to be eligible for the studies;
* Agrees to identify a suitable space for personalised music listening to be trialled;
* Agrees to make staff available to select residents and support the studies;
A resident meeting all of the following criteria will be eligible to participate in the feasibility studies:
* A permanent resident within a care home run by the Quantum Care Home Group;
* Has been assessed by suitably qualified/trained care home staff (or a medical professional) as having symptoms and signs of dementia (of any type).
* Has one or more family member/carer willing to participate in this study by providing sufficient responses to a questionnaire about the resident's musical preferences and background and feedback on the resident's responses to listening to personalised music.
* Has the ability to communicate in English; and
* For participants who are assessed as lacking mental capacity to consent to participation, has an attorney or Consultee willing to support their inclusion in the study.
An informal carer meeting all of the following criteria will be eligible to participate in the feasibility studies:
* People above the age of 18 who are a family member or friend and act as an informal carer for a participant with dementia.
* Has the ability to communicate in English.
A care home staff meeting the following criteria will be eligible to participate in the feasibility study:
* Health and social care staff, paid to provide care to individuals with dementia within participating care homes. This may include Managers, Registered Nursing staff, Care Assistants or Activity Coordinators.
* Has the ability to communicate in English.
Exclusion Criteria:
A care home meeting any of the following criteria will not be eligible to join the feasibility study if it is:
* Rated at the last Care Quality Commission (CQC) inspection as Needs Improvement or Inadequate;
* Subject to CQC enforcement notices, admission bans or major CQC compliance issues;
* Currently, or has recently been involved in, another research study or trial that conflicts with personalised music or with data collection during the course of these studies.
A resident meeting any of the following criteria will not be eligible to participate in the feasibility studies:
* Assessed by care home staff or a medical professional as having severe depression;
* Assessed as being unable to hear music through headphones;
* Is so severely physically impaired as to make it unlikely that the researchers, carers or informal carers will be able to observe responses to personalised music through (for example, changes in facial expression, tapping of feet or fingers etc)
* Is currently, or has recently been involved in, another research study or trial that conflicts with personalised music listening or with data collection during the course of these studies;
* Is expected to die before the completion of their participation in the study.
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