Plain English Summary
Background and study aims
Dementia is a syndrome (a group of related symptoms) associated with an ongoing decline of the brain and its abilities. Music interventions have the potential to improve quality of life significantly for individuals living with dementia and their families. However, scientific evidence to support the use of a specific intervention within the health service is currently lacking. This study will test the procedures for a full study of an interactive music programme for individuals living with dementia in hospital wards or care homes, which has recently been developed by Scottish Chamber Orchestra in collaboration with the University of Edinburgh.
Who can participate?
Patients with a diagnosis of moderate to severe dementia from a hospital ward in Edinburgh, UK
What does the study involve?
Participants are randomly allocated to one of two groups. One group attends one-hour Interactive Music Workshops, provided by the Scottish Chamber Orchestra and led by an experienced music workshop leader, once a week for eight weeks. Trained musicians perform favourite or familiar music, while participants are encouraged to take part by moving, singing or joining in on instruments, as they wish. The other group attends one-hour Music Listening Workshops, led by an experienced music workshop leader, once a week for eight weeks. In-depth interviews are carried out with carers, health staff and intervention staff (musicians and workshop leader) to assess their views. The aim is to establish how many participants would be needed in a full study for the results to be useful, what proportion of eligible patients are likely to take part, and how acceptable and practical the research procedures and music intervention are from the point of view of those involved.
What are the possible benefits and risks of participating?
The possible benefits of taking part include positive engagement in a shared musical experience for individuals who have lost the ability to communicate verbally. The possible risks of taking part include any upset caused by a disruption of the normal daily routine, and/or any discomfort in response to the music selected for the workshop. Staff and workshop leaders will monitor any participants’ apparent state of ease and behaviour throughout the sessions and take action where necessary to avoid any negative impact.
Where is the study run from?
NHS Lothian (UK)
When is the study starting and how long is it expected to run for?
July 2016 to December 2016
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
1. Dr Katie Overy
2. Dr Graeme Wilson
3. Dr Sheila Rodgers
Trial website
Contact information
Type
Scientific
Primary contact
Dr Katie Overy
ORCID ID
http://orcid.org/0000-0002-7271-8439
Contact details
IMHSD
Reid School of Music
Alison House
12 Nicolson Square
The University of Edinburgh
Edinburgh
EH8 9DF
United Kingdom
Type
Scientific
Additional contact
Dr Graeme Wilson
ORCID ID
Contact details
Reid School of Music
Alison House
12 Nicolson Square
The University of Edinburgh
Edinburgh
EH8 9DF
United Kingdom
Type
Scientific
Additional contact
Dr Sheila Rodgers
ORCID ID
Contact details
Medical School (Doorway 6)
Teviot Row
Edinburgh
EH8 9AG
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CGA/16/8
Study information
Scientific title
Pilot trial of an interactive music intervention for individuals living with moderate to severe dementia
Acronym
IMID - Interactive Music in Dementia
Study hypothesis
This pilot study will assess the feasibility of a fully randomised control trial by identifying: rates of eligibility, recruitment and retention; acceptability and practicality of trial procedures for patients, their relatives and staff; effect sizes; intervention and outcome measure protocols.
Ethics approval
Scotland A Research Ethics Committee, NHS Lothian, application submitted on 27/06/2016, meeting scheduled for 28/07/2016 - approval pending
Study design
Single-centre between-groups comparison with randomised per-patient allocation to group and a nested qualitative study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Moderate to severe dementia
Intervention
Participants will be recruited from the same ward and randomly allocated, per-patient, to either group.
Experimental Condition: One-hour Interactive Music Workshops for groups of up to ten patients, provided by the Scottish Chamber Orchestra (SCO) and led by an experienced music workshop leader, once a week for eight weeks. Trained musicians will perform favourite or familiar music, while participants are facilitated and encouraged to take part by moving, singing or joining in on instruments, as they wish.
Control Condition: One-hour Music Listening Workshops, led by an experienced music workshop leader, once a week for eight weeks.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Rate of eligibility for the trial, measured prior to recruitment as a percentage of patients resident on the ward
2. Rate of recruitment, measured after informed consent has been granted for all participants and before the interventions begin, as a percentage of patients who were identified as eligible for the study
3. Rate of retention, measured after the study as a percentage of patients who were originally recruited to the study
Secondary outcome measures
1. Effect sizes of scores of patients on the Cohen-Mansfield Agitation Index (CMAI), measured immediately before, half-way through and two weeks after the music interventions
2. Effect sizes of scores of patients on the Music and Dementia Observation Tool (in-house tool specially designed for this study), measured during each music workshop
3. Post-intervention interview responses from individuals from the care team about their experience of the workshops and any observed impact
4. Post-intervention interview responses from patient relatives about their experience of the workshops and any observed impact
5. Post-intervention interview responses from the musicians and workshops leaders about their experience of the workshops and any observed impact
Overall trial start date
01/07/2016
Overall trial end date
30/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Resident on the same hospital ward
2. Diagnosis of Moderate to Severe Dementia and deemed to lack capacity according to the BMA toolkit, taking into account law in Scotland
3. Informed consent provided by nearest relative, guardian or welfare attorney, or for those without, the appointed IMCA (Independent Mental Capacity Advocate)
4. Aged between 16 and 110 years
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Significant hearing problems
2. Not able to remain comfortably located in the communal space during the workshop
3. Expected to be discharged and moved to another hospital ward/care home during the intervention
4. Informed consent not provided by nearest relative, guardian or welfare attorney, or for those without, the appointed IMCA (Independent Mental Capacity Advocate)
Recruitment start date
08/08/2016
Recruitment end date
26/08/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
NHS Lothian
Waverley Gate
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Funders
Funder type
Government
Funder name
Chief Scientist Office
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
30/12/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary