Generating and Using Personalised Music Playlists to Improve Behavioural and Psychological Symptoms in People With Dementia: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- Median time (in hours) required to generate personalised music playlists for participants living with dementia assessed using activity logs recorded by researchers, carers and/or relatives/friends.
研究概览
简要总结
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:
- To extend the main study to include participants who may lack capacity to consent.
- 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.
详细描述
This research will adopt a mixed methods design for the study involving both quantitative and qualitative data collected and analysed simultaneously, then compared or related and interpreted.
Up to 10 participating care homes will be selected by Quantum Care Home Group in line with the inclusion/exclusion criteria. A total of 80 participating residents living with dementia, 80 informal carers and 20 care home staff will be selected from the participating care homes.
This study will explore:
- The most effective and efficient methods for creating personalised playlists, including developing automated approaches, using technology (e.g. Apps and music recommendation algorithms).
- The most easy-to-implement delivery methods for delivering personalised music to residents in care homes.
- The most effective ways to assess responses to personalised music from people with dementia, including trialling automated analysis of changes in facial expression in video footage.
- Initial impressions of whether factors such as timing of listening affect the observed impacts of listening to personalised music or whether listening prior to difficult care events appears to be beneficial (e.g. dressing, washing, toileting, sundowning, etc.).
A personalised playlist of about 100 songs will be created using responses to the music preferences questionnaire provided by the resident and their informal carer/Consultee/attorney (or paid carer). These questionnaires will be provided by the research team to the potential participants, identified by care home staff, together with the information pack and consent forms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Median time (in hours) required to generate personalised music playlists for participants living with dementia assessed using activity logs recorded by researchers, carers and/or relatives/friends.
时间窗: 6 months per participant
The primary outcome sought is the ability to generate a personalised playlist for a person living with dementia requiring an aggregate time input from the researchers, relatives/friends and/or their paid carer(s) of under 2 hours. This time input will consist of the time required to complete the music preferences questionnaire and the total elapsed time of the music listening session. During that music listening session, excerpts of tracks from a long list of 100 songs generated form the questionnaire responses are played to the person living with dementia and those tracks that elicit the strongest positive responses will be included in their final personalised playlist. The time required for each of these tasks will be recorded in activity logs by the researchers, carers and/or relatives/friends of the person living with dementia.
Acceptability by participants of the delivery method(s) of personalised playlists in care homes, assessed through qualitative methods such as feedback from participants (people living with dementia, their relatives/friends and their carers).
时间窗: 6 months per participant
A range of different methods will be tested to deliver (play) personalised music playlists once they are generated. The acceptance (or otherwise) of these methods (e.g. use of headphones, smart speakers, etc) will be assessed through qualitative research by gathering feedback from participants (people living with dementia, their relatives/friends and their carers) including from activity logs completed by carers and/or relative/friends, focus groups with carers and relative/friends and interviews with participants.
次要结局
- Extent of correlation between measures of emotional responses of people living with dementia to personalised music listening (using facial expression change algorithm) with direct observation by researchers, documented in activity logs.(6 months per participant)
- Assessing the feasibility of acquiring functional magnetic resonance imaging (fMRI) data while listening to personalised music(4 months per participant)