Benefits of Personalised Music in Dementia - a Feasibility Study

Generating and Using Personalised Music Playlists to Improve Behavioural and Psychological Symptoms in People With Dementia: a Feasibility Study

Sponsors

Lead Sponsor: Music for my Mind

Source Music for my Mind
Brief Summary

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.

Detailed Description

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 60 participating residents living with dementia, 60 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 trialing automated analysis of changes in facial expression in video footage.

4. Whether factors such as timing of listening affect the observed impacts of listening to personalised music or whether listening prior to difficult care events is beneficial (e.g. dressing, washing, toileting, sundowning, etc.).

The demographics of the study group will be compared with the available demographics for care homes across the care home group, to help ensure the sample is broadly representative.

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 (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 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.

Personalised music listening should not require expensive equipment but will require headphones or a suitable blue-tooth speaker and a space in a care home where the resident can listen to their music. Initiating and terminating a listening session should be a simple matter for care home staff (taking only 1 or 2 minutes), potentially achieved by fitting/removing headphones and voice activation/cessation of the music plus a minute or two to complete the log. 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 residents, care home staff and 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-Questionnaire (NPI-Q), including for depression/apathy and anxiety/agitation. It is expected that these tools will be used 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 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 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.

Informed consent for participation will be obtained, including for participation by informal carers 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 will provide qualitative assessments of any benefits or dis-benefits 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 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 dis-benefits 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 advanced dementia (whom the research team hopes to include in a subsequent feasibility study) may lack the capacity to communicate their music preference or emotional responses to listening to music, this study will 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.

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

Overall Status Recruiting
Start Date November 28, 2019
Completion Date December 31, 2021
Primary Completion Date December 31, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
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. 6 months per participant
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). 6 months per participant
Secondary Outcome
Measure Time Frame
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
Enrollment 140
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Personalised music listening

Description: People will be sequentially recruited to discover their favourite music playlist, monitor their emotional responses to specific songs and explore the impact of listening to the music, on their behavioural and psychological symptoms. This will be done through a one hour music listening session, to discover the top 10-20 songs they respond to. It will then be followed by multiple shorter music listening sessions, initiated by the dementia resident themselves or their carer, where they listen to their favourite songs during their day, before difficult moments of care or during visits with their families.

Arm Group Label: People living with dementia, their families and carers

Eligibility

Sampling Method: Non-Probability Sample

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 music listening to be trialed;

- 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 mild to moderate dementia (of any type) and as having the mental capacity to give informed consent to participation in this study.

- 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.

A person 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. Inclusion criteria for care home staff

A person 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 lacking capacity to give informed consent;

- 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.

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Keith McAdam Principal Investigator Music for my Mind
Overall Contact

Last Name: Keith McAdam

Phone: 07890298514

Phone Ext.: +44

Email: [email protected]

Location
Facility: Status: Contact: Willow Court Dimana Georgieva 07871535477 +44 [email protected]
Location Countries

United Kingdom

Verification Date

February 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: People living with dementia, their families and carers

Description: The cohort consists of people living with mild to moderate dementia. Each of them will be accompanied, throughout the study, by a family member or friend. They will take part together in a one hour music listening session, to discover their personalised playlist. Where possible, a care home staff member will join in, in order to witness the benefits of the music to the dementia resident and learn how to provide the music, as part of their care in the care home.

Patient Data No
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov