Condition category
Mental and Behavioural Disorders
Date applied
03/02/2020
Date assigned
12/05/2020
Last edited
12/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Dementia affects about 800,000 people in the UK, with the number expected to rise. As well as searching for medical treatments for dementia, there is a need for helpful social activities to support people with dementia to live well with the condition. People with dementia are at risk of social isolation and mental health problems, and family carers can feel unsupported and over-burdened by their role. Studies have suggested that group singing can improve mood, memory and relationships for people with dementia, and establish support networks which help carers. The shared activity of singing together may have benefits for the relationship between person with dementia and carer too. However, to date no large scale studies about community singing and dementia have been conducted. This study is a feasibility study, meaning that it aims to try out a study design to see if it would work on a larger scale. In particular, we want to see if we can recruit enough people to take part in the study, and whether they will remain in the study for long enough to collect all the data we need.

Who can participate?
Patients who have received a diagnosis of dementia, who are willing to join a singing group, and who have a carer who is willing to join the study with them.

What does the study involve?
Participants will be randomly assigned to either attend group singing straight away, or to wait for 10 weeks before attending group singing. We will collect data about their quality of life, mood, and cognitive function at several time points, so we can compare the differences between people who attend singing straight away and those who wait. The data we collect from this feasibility study will allow us to plan a larger trial of singing for people with dementia.

What are the possible benefits and risks of participating?
Participants in the study will have the opportunity to attend singing groups. Many attendees at these groups report finding them stimulating and enjoyable. However, not everyone will necessarily enjoy the singing groups even if others do (for example, if they do not like the songs chosen for a certain week). Participants will also be asked to complete questionnaires and tests three times during the study. Every effort will be made to ensure this is experience is not too tiring or difficult, but some participants may find it burdensome.

Where is the study run from?
The study is run from the University of Nottingham. The singing groups will take place in community venues in the Nottingham area.

When is the study starting and how long is it expected to run for?
June 2019 to May 2021

Who is funding the study?
1. Alzheimer's Society (UK)
2. National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof. Justine Schneider, justine.schneider@nottingham.ac.uk

Trial website

https://www.nottingham.ac.uk/research/groups/preside/

Contact information

Type

Scientific

Primary contact

Prof Justine Schneider

ORCID ID

http://orcid.org/0000-0002-5863-7747

Contact details

University of Nottingham
School of Sociology & Social Policy
University Park
Nottingham
NG7 2RD
United Kingdom
+44 (0)1158467307
justine.schneider@nottingham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 43783, IRAS 256110

Study information

Scientific title

Pilot Randomised Evaluation of Singing in Dementia

Acronym

PRESIDE

Study hypothesis

It will be possible to undertake a randomised trial of singing in dementia with these parameters: 70% of recruitment target met, 70% of control participants randomised to the intervention after 3 months, and the study design and measures found to be acceptable to participants.

Ethics approval

Approved 07/01/2020, Social Care Research Ethics Committee (Skipton House, Ground Floor, 80 London Road, London, SE1 6LH, UK; +44 (0)207 104 8035; socialcare.rec@hra.nhs.uk), ref: 19/IEC08/0056

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dementia

Intervention

The intervention will consist of a weekly singing session delivered by an experienced leader of singing in dementia, supported by volunteers in a ratio of 1 volunteer to 5 couples, and with an instrumentalist (guitar or piano). The intervention will be delivered in groups of up to 20 couples
where one partner has dementia. Sessions will last up to 2 h, with 30 min allocated for socialising before or after the session. Learning new songs, singing solos and using percussion instruments will all be included in the sessions routinely. The content of each session will be fully documented to contribute to a process evaluation, which will form part of the research. Video will be used to record samples of sessions.

The control intervention will be a waiting period of care as usual for 3 months, after which control participants will be invited to attend singing group sessions.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Feasibility of a full-scale trial:
1. Recruitment measured using records at end of study
2. Retention measured using records at end of study
3. Acceptability of waiting-list design measured using proportion of waiting-list participants who start attending singing group after the waiting period

Secondary outcome measures

At baseline, 3 months after baseline and 6 months after baseline:
Carers:
1. Quality of life measured using QoL-AD proxy
2. Mood measured using Geriatric Depression Scale
3. Relationship quality measured using Quality of the Carer-Patient Relationship Scale
4. Impact and experience of caregiving measured using Carers of Older People in Europe index
5. Caregiver burden measured using Short Sense of Competence Questionnaire
6. Quality of life measured using EQ-5D-5L
7. Treatment cost measured using Client Service Receipt Inventory

People with dementia:
8. Quality of life measured using QoL-AD
9. Quality of life measured using EQ-5D-5L
10. Quality of life measured using DEMQOL
11. Dementia severity measured using Clinical Dementia Rating
12. Mood measured using Geriatric Depression Scale
13. Cognitive skills measured using ADAS-Cog
14. Mood measured using Cornell Scale for Depression Dementia
15. Engagement with music measured using Music Engagement Questionnaire
16. Ability to carry out daily activities measured using Bristol Activities of Daily Living Scale
17. Treatment cost measured using Client Service Receipt Inventory

Overall trial start date

01/06/2019

Overall trial end date

31/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Participant speaks and understands English
2. Over 18 years of age
3. New to the singing intervention and willing to join a singing group
4. Received a diagnosis of dementia
5. MMSE score of 10 or more (or MoCA score from 2 to 15 points)
6. Care partner who spends at least 2 h per week with them and is willing to join the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 160; UK Sample Size: 160

Participant exclusion criteria

1. Has participated in a singing group in the past six weeks
2. Profoundly deaf
3. History of severe mental illness, alcohol or drug dependency
4. Unwilling to give informed consent or lacking mental capacity under Mental Capacity Act (MCA) and personal consultee advises against participation. We shall not use nominated consultees under the MCA because such participants would not fit the inclusion criteria of having a relative or friend to accompany them in the study

Recruitment start date

14/01/2020

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
School of Sociology & Social Policy Law & Social Sciences Building University Park
Nottingham
NG7 2RD
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

Research and Innovation
East Atrium
Jubilee Conference Centre
Nottingham
NG8 1DH
United Kingdom
+44 (0)1158467906
sponsor@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Charity

Funder name

Alzheimer's Society

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Associations and societies (private and public)

Location

United Kingdom

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

31/05/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/02/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).