Benefits of Personalised Music in Dementia - a Feasibility Study

NCT04132362 | Recruiting

• 1 other identifier: MFMM265263
• Study Type: observational
• Target: 1,080
• Locations: 1 country
• Sites: 1

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 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. 1.To extend the main study to include participants who may lack capacity to consent.
2. 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.

Conditions

Dementia

Keywords

music; dementia; emotional responses

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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).

  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.

  6 months per participant

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Number of participants who exhibit improved well-being following a period of listening to personalised playlists as part of their care package, measured through changes in quality of life measures and Behavioural and Psychological Symptoms as a proxy.

  6 months per participant

Study Arms (1)

People living with dementia, their families and carers

The cohort consists of people living with 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.

Behavioral: Personalised music listening; Behavioral: Using fMRI to investigate the effect of listening to personalised music evoking positive emotional response on brain activation; Behavioral: Personalised music listening in the community

Interventions

Personalised music listening BEHAVIORAL

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.

People living with dementia, their families and carers

Using fMRI to investigate the effect of listening to personalised music evoking positive emotional response on brain activation BEHAVIORAL

12 of the recruited participants, who have symptoms and signs of mild to moderate dementia will be invited to take part in this sub-study. Using an amended version of a previously employed fMRI paradigm, each study participant will be presented inside the MRI scanner with short 30 second epochs of music (identified as evoking a positive or neutral emotional response) in a block design. Each 30 second epoch of music will be followed by a 16 second period when participants will be asked to rate subjective changes in their affective state using a computerised visual analogue scale. Epochs of positive emotional stimuli will alternate with epochs of neutral emotional stimuli in a counterbalanced order of presentation in 2 runs of 10 epochs each (5 positive and 5 neutral in each run).

People living with dementia, their families and carers

Personalised music listening in the community BEHAVIORAL

1000 families affected by dementia will be invited to use our WebApp to create a personalised playlist for their loved one with dementia and share their perceptions of how the music has affected the well-being of their loved one.

People living with dementia, their families and carers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

80 residents living with dementia, from up to 10 different care homes. Up to 80 informal carers, participating in music listening sessions, focus groups and/or providing feedback. Up to 20 care home staff, participating in focus groups or interviews. In addition, all staff in participating care homes will participate in administration of personalised music interventions. Up to 1000 families affected by dementia living at home or in the community.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Music for my Mind: lead

Study Sites (1)

Willow Court

Harpenden, Hertfordshire, AL5 5SD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Keith McAdam

  Music for my Mind

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith McAdam

CONTACT

07890298514; keith@musicformymind.com

Dimana P Georgieva

CONTACT

07871535477; dimana@musicformymind.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 18, 2019
• Study Start: November 28, 2019
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)