Benefits of Personalised Music in Dementia - a Feasibility Study
Benefits of Personalised Music in Dementia - a Feasibility Study
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, subject to subsequent ethical approval, 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.
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:

 1. The most effective and efficient methods for creating personalised playlists, including
 developing automated approaches, using technology (e.g. Apps and music recommendation
 algorithms).

 2. The most easy-to-implement delivery methods for delivering personalised music to
 residents in care homes.

 3. 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.

 4. 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.

 A music listening session will be arranged where the resident and their informal
 carer/Consultee/attorney will be played 30 seconds excerpts of each of the tracks (in 15
 minute blocks over a period of up to 1 hour). The resident will be asked to wear a monitor on
 their wrist, similar to a watch, in order to monitor movement and pulse rate. The session
 will be filmed to enable analysis of emotional responses to music using machine learning
 analysis of changes in facial expression, as well as directly observed movements of hands,
 feet and/ or head. Where necessary the music listening session can be split into multiple
 shorter sessions to accommodate resident or care home requirements. Responses to the 30
 second excerpts will be used to generate a refined personalised playlist for each
 participant, anticipated to be between 10 and 20 tracks.

 The refined personalised playlists will be played to residents in music listening sessions
 throughout the duration of the study. How long music is played for and how frequently will,
 for the feasibility study, be determined by the resident, care home staff and/or informal
 carers. Different delivery methods for delivering personalised music will be tested including
 use of wireless headphones, smart speakers or other wireless speakers and their effectiveness
 and ease of use assessed through feedback from residents and focus groups and interviews with
 informal carers and care home staff. Duration and frequency of music listening sessions will,
 where possible, be logged through the listening history in the music app used and/or through
 data recorded by care home staff or informal carers.

 A short training session will be provided in each participating care home to train staff and
 informal carers on delivering personalised music listening and collecting observational data
 (e.g. on timing of listening and observed effects on mood and behaviour). Fidelity,
 acceptability and appropriateness of the interventions will be assessed by the research team
 through the observation of selected personalised music listening sessions.

 Approaches to assessing responses to the music that will be used include analysis of facial
 expression changes and movement in video footage, heart rate changes and qualitative
 information provided in reports from a member of the research team, residents, care home
 staff and/or informal carers. Impacts on well-being of residents over time will be assessed
 using scores derived from inventories for behavioural and psychological symptom assessment as
 a proxy, e.g. The Neuropsychiatric Inventory Nursing Home Version (NPI-NH), including for
 depression/apathy and anxiety/agitation. The Health-Related Quality of Life Measure for
 people living with dementia (DEMQOL) and DEMQOL-Proxy (administered with the informal
 carer/Consultee) will also be completed. It is expected that these tools will be used before
 the intervention and between 1 and 3 further times for each resident participant at
 appropriate intervals during the period of the study.

 For this study the use of qualitative and quantitative assessment tools is for the purpose of
 developing and testing the appropriateness of personalised music listening and assessment
 methodologies rather than to draw conclusions about efficacy or otherwise of the intervention
 itself (which would be the subject of further studies subject to subsequent ethical
 approval). The quantitative data generated, therefore will only be used to supplement
 qualitative assessments to help infer/indicate factors for further investigation in
 subsequent feasibility studies and a longer-term larger scale intervention study i.e. to
 inform the design of those studies. Therefore, in this feasibility study, analysis of the
 quantitative measures is not intended to produce statistically significant data (the
 statistics involved will be mostly descriptive and, in some cases, inferential). Together
 with subsequent feasibility studies, it is intended to inform the design of the larger scale
 intervention study in which the sample size will be calculated to produce statistically
 significant results.

 The study will trial the use of facial expression change through automated analysis of video
 footage. The initial pilot showed a strong correlation between the scores, indicating that,
 after further calibration, absolute thresholds can be derived to classify a track as either
 high or low response. Deep-learning facial expression change analysis will be developed to
 determine the feasibility or otherwise of using automated analysis of facial expression
 change in video footage. This will involve:

 -  Acquiring videos at 30 frames per second while music is played, extracting 1 image per
 second and generating 3 features for each.

 -  Performing face detection using Microsoft Azure Cognitive Services Application
 Programming Interface (API) and extracting an emotion score from the facial expression
 in 8 categories: anger, contempt, disgust, fear, happiness, neutral, sadness, and
 surprise. The research team will then form a secondary score based on a linear
 combination of these expressions and assign it to each frame.

 -  The research team will then aggregate the values of all frames acquired while a track
 was played to form a total response score by assigning different weights to the frames
 and deriving first-order statistics from the resulting distribution. The researchers can
 then compare the scores to subjective observation.

 The views of care home staff and informal carers/Consultees/attorneys about the intervention
 will be sought throughout the study, via the means of focus group discussions and interviews.
 These focus group discussions and interviews will be conducted with care home staff and
 families in order to explore their views of how personalised playlists have an impact on
 residents including their impressions of the effect of variables such as timing of listening
 or the impact on difficult care situations. Direct feedback will also be sought from
 participating residents themselves, where feasible.

 Informed consent for participation will be obtained, including for participation by informal
 carers/Consultees and care home staff, as well as residents. If anyone participating in the
 study, in any way indicates that they do not want to take part or in any way indicates that
 they are unhappy or distressed, then their participation will be paused (e.g. a different
 track played or a different question asked) and if the distress persists, the session will be
 stopped.

 Informal carers/Consultees/attorneys will provide qualitative assessments of any benefits or
 disbenefits to them arising from the impact of personalised music listening on the
 behavioural and psychological symptoms of their relative/friend (e.g. improving relationship
 with carers and family). These assessments will be provided through participation in
 structured focus groups. Informal carers/Consultees/attorneys will participate in up to 3
 focus groups, conducted by a member of the research team, experienced in qualitative
 research, once the refined personalised playlist is completed, between 2 and 4 months later
 and at the conclusion of their participation in the study.

 Care home staff will provide qualitative assessments of any benefits or disbenefits to them
 arising from the impact of personalised music listening on the behavioural and psychological
 symptoms of the resident, for example:

 -  improving relationship with carers and family;

 -  improved quality or ease of care provision such as easing of distress caused by
 difficult care events.; and

 -  ease of incorporation of personalised music therapy into the usual working practices of
 the care homes.

 These assessments will be provided through participation in structured focus groups. Care
 home staff will participate in up to 3 focus groups, conducted by a member of the research
 team, experienced in qualitative research, once the refined personalised playlist is
 completed, 2-4 months afterwards and at the conclusion of their participation in the study.
 If the care home staff are unable to participate in a focus group, a semi-structured 1:1
 interview will be conducted instead.

 As individuals with more severe dementia may lack the capacity to communicate their music
 preference or emotional responses to listening to music, this study will both:

 -  explore using the outcome measures as an objective way of gauging their preferences and
 responses by comparing responses measured through biomarkers and subjective assessments
 given by individuals living with less severe stages of dementia and their carers, family
 and/or friends; and

 -  work directly with people with advanced dementia who are not able to communicate their
 music preferences or emotional responses to listening to music, instead gathering such
 information from their carers, family and/or friends and measuring responses through
 biomarkers and subjective assessments given by these individuals.

 The eventual larger scale study will explore issues of cost effectiveness, in addition to
 clinical effectiveness.

 Pilot sub-study: Benefits of personalised music in dementia - a pilot study to investigate
 mechanisms of action

 12 of the 80 participants (who have capacity to provide informed consent) will be further
 invited to take part in a pilot sub-study to investigate mechanisms of action.The capacity of
 residents to give consent will be assessed and documented by care home staff. The
 participants will be provided with an information sheet about the sub-study, consent forms
 and an MRI Safety Screen Questionnaire. This pilot study will help develop the mechanistic
 rationale for a larger scale intervention study to explore the effects of personalised music
 on behavioural and psychological symptoms in people with dementia.
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.