How does community group singing affect the wellbeing of people with dementia and their carers?
| ISRCTN | ISRCTN10201482 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10201482 |
| IRAS number | 256110 |
| Secondary identifying numbers | CPMS 43783, IRAS 256110 |
- Submission date
- 03/02/2020
- Registration date
- 12/05/2020
- Last edited
- 14/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 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, Lincoln, and Leicester areas.
When is the study starting and how long is it expected to run for?
June 2019 to December 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Prof Justine Schneider, justine.schneider@nottingham.ac.uk
2. Dr Becky Dowson, Becky.Dowson@nottingham.ac.uk
Contact information
Scientific
University of Nottingham
School of Sociology & Social Policy
University Park
Nottingham
NG7 2RD
United Kingdom
 ORCID ID |
0000-0002-5863-7747 |
|---|---|
| Phone | +44 (0)1158467307 |
| justine.schneider@nottingham.ac.uk |
Scientific
University of Nottingham
D floor, Institute of Mental Health
Jubilee Campus
Nottingham
NG7 2TU
United Kingdom
| ORCID ID |
0000-0002-1310-2941 |
|---|---|
| Phone | +44 (0)115 74 84315 |
| Becky.Dowson@nottingham.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Preliminary Randomised Evaluation of Singing in Dementia |
| Study acronym | PRESIDE 2024 |
| Study objectives | 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(s) | Current ethics approval: Approved 19/08/2022, Wales Research Ethics Committee 3 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)2920 230457, +44 (0)7920 565664; Wales.REC3@wales.nhs.uk), ref: none provided Previous 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 |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | Current intervention as of 16/06/2022: 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 28 couples where one partner has dementia. Sessions will last up to 1.5 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. Previous 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 |
| 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 | Current secondary outcome measures as of 16/06/2022: At baseline, 3 months after baseline, and 6 months after baseline: Carers: 1. Experience and implications of caregiving measured by SIDECAR (Scales measuring the Impact of Dementia on Carers) 2. Mood measured using Geriatric Depression Scale 3. Wellbeing measured using the Short Warwick-Edinburgh Mental Wellbeing Scale 4. Loneliness measure using the Three-item Loneliness Scale 5. Quality of life measured using EQ-5D-5L 6. Treatment cost measured using Client Service Receipt Inventory People with dementia: 7. Quality of life measured using EQ-5D-5L 8. Quality of life measured using DEMQOL 9. Cognitive performance measured using Mini Mental State Examination 10. Mood measured using Geriatric Depression Scale 11. Social engagement and independence measured using Engagement and Independence in Dementia Questionnaire 12. Dementia core outcomes measured using Dementia Core Outcome Set 13. Wellbeing measured using the Short Warwick-Edinburgh Mental Wellbeing Scale 14. Engagement with music measured using Music Engagement Questionnaire 15. Loneliness measure using the Three-item Loneliness Scale 16. Treatment cost measured using Client Service Receipt Inventory Previous 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 study start date | 01/06/2019 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 160; UK Sample Size: 160 |
| Key inclusion criteria | Current participant inclusion criteria as of 16/06/2022: Participant with dementia: 1. To be diagnosed with dementia which is at a mild or moderate level 2. Aged ≥18 years 3. To have a carer who spends at least 2 h per week with them and who is willing to attend the group 4. Willing to join a singing group and attend weekly 5. Able to give informed consent 6. Able to speak and understand English. Carer: 1. Able to speak and understand English. 2. Willing in principle to attend the group regularly 3. Able to give informed consent Previous 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 |
| Key exclusion criteria | Current participant exclusion criteria as of 16/06/2022: Participants with dementia: 1. Lacking capacity to give informed consent 2. Has engaged regularly in a singing group (other than religious services) in the past 6 weeks 3. Significant hearing impairment 4. Simultaneous participation in any other interventional study. 5. History of severe mental illness, or alcohol/drug addiction Carers: 1. Lacking capacity to give informed consent 2. Significant hearing impairment 3. Simultaneous participation in any other interventional study. 4. History of severe mental illness, or alcohol/drug addiction Previous 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 |
| Date of first enrolment | 01/09/2022 |
| Date of final enrolment | 31/08/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Law & Social Sciences Building
University Park
Nottingham
NG7 2RD
United Kingdom
Duncan Macmillan House
Porchester Road
Nottingham
NG3 6AA
United Kingdom
Long Leys Road
Lincoln
LN1 1FS
United Kingdom
1st Floor
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
Sponsor information
University/education
Research and Innovation
East Atrium
Jubilee Conference Centre
Nottingham
NG8 1DH
England
United Kingdom
| Phone | +44 (0)1158467906 |
|---|---|
| sponsor@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/01/2021 | 12/01/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 03/03/2025 | 14/03/2025 | Yes | No |
Editorial Notes
14/03/2025: Publication reference added.
07/09/2022: Ethics approval added.
14/07/2022: A study contact has been added and the plain English summary has been updated accordingly.
16/06/2022: The PRESIDE study was unable to take place due to the pandemic. The below changes have been made to the trial record to reflect changes to the study, arising from work carried out by the study team during the pandemic, in a renewed attempt to continue conducting this research under the new acronym of PRESIDE 2024 and a different funder. Recruitment to this study is no longer paused and the following changes have been made:
1. The scientific title has been changed from "Pilot Randomised Evaluation of Singing in Dementia" to "Preliminary Randomised Evaluation of Singing in Dementia".
2. The acronym has been changed from "PRESIDE" to "PRESIDE 2024".
3. The ethics approval has been updated.
4. The overall trial end date has been changed from 31/05/2021 to 31/12/2023.
5. The intervention has been updated.
6. The secondary outcome measures have been updated.
7. The participation inclusion criteria have been updated.
8. The participation exclusion criteria have been updated.
9. The recruitment start date has been changed from 14/01/2020 to 01/09/2022.
10. The recruitment end date has been changed from 31/12/2020 to 31/08/2023.
11. The trial participating centres “Nottinghamshire Healthcare NHS Foundation Trust”, “Lincolnshire Partnership NHS Foundation Trust”, and “NIHR CRN East Midlands” have been added.
12. The intention to publish date has been changed from 31/05/2022 to 31/03/2025.
13. The funder "Alzheimer's Society" has been removed and the funder type has been updated from "Charity" to "Government".
14. The plain English summary has been updated to reflect the changes above.
12/01/2021: Publication reference added.
05/02/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).
