Preliminary Randomised Evaluation of Singing in Dementia

NCT05573750 | Unknown DMC

• 4 other identifiers: IRAS2561102022-003055-34NIHR202982CPMS43783
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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 experience is not too tiring or difficult, but some participants may find it burdensome.

Conditions

Dementia

Keywords

Dementia; Singing

Outcome Measures

Primary Outcomes (2)

• Recruitment rate of participants

  Recruitment rate is the number of participants recruited throughout the study compared to the set number of participants required to reach statistical power. To assess the feasibility of gaining recruitment into community singing groups with the potential of having a waiting-list control group is investigated. Recruitment of all participants into the study against target figures will be reported as a recruitment rate (as a percentage or ratio) and form an independent unit of measure to provide an indication whether or not recruitment targets are likely to be achieved should a randomised control trial be pursued.

  2 years

• Retention rate of participants

  Retention rate is calculated by measuring the number of participants who were recruited into the study against the number of participants that completed the duration of the study (either by percentage or ratio). Retention rate of all participants as a unit of measure throughout the two-year period will be analysed. Waiting list control group participant retention data will be compared against intervention group participant retention data which will provide an understanding as to whether participants would be willing to wait to participate in the group singing activities. This provides a unit of measure to calculate the feasibility of the waiting list control study design. Participant retention rates (using the unit of measure outlined above) will be analysed throughout the two-year period to further investigate if and when participants may be at risk of study withdrawal (reported as either a percentage or a ratio).

  2 years

Secondary Outcomes (10)

• Scales measuring the impact of Dementia on Carers

  6 months

• The Geriatric Depression Scale

  6 months

• Short Warwick-Edinburgh Mental Wellbeing Scale

  6 months

• Three-item Loneliness Scale

  6 months

• EuroQoL-5D-5L

  6 months

Other Outcomes (1)

• The Music in Dementia Assessment Scale

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Singing groups with an instrument

Behavioral: Singing group

Control (delayed intervention)

OTHER

Delayed comparator

Behavioral: Singing group

Interventions

Singing group BEHAVIORAL

Intervention involves singing groups with person with dementia and carer. Please see earlier descriptions.

Control (delayed intervention); Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant with dementia:
• To be diagnosed with dementia which is at a mild or moderate level
• Aged ≥18 years
• To have a carer who spends at least 2 h per week with them and who is willing to attend the group
• Willing to join a singing group and attend weekly
• Able to give informed consent
• Able to speak and understand English.
• Carer:
• Able to speak and understand English.
• Willing in principle to attend the group regularly
• Able to give informed consent

You may not qualify if:

• Participants with dementia:
• Lacking capacity to give informed consent
• Has engaged regularly in a singing group (other than religious services) in the past 6 weeks
• Significant hearing impairment
• Simultaneous participation in any other interventional study.
• History of severe mental illness, or alcohol/drug addiction
• Carers:
• Lacking capacity to give informed consent
• Significant hearing impairment
• Simultaneous participation in any other interventional study.
• History of severe mental illness, or alcohol/drug addiction

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (2)

Institute of Mental Health

Nottingham, Nottinghamshire, NG7 2TU, United Kingdom

RECRUITING

Nottinghamshire Health Care NHS Trust

Nottingham, NG3 6AA, United Kingdom

RECRUITING

Related Links

• University of Nottingham Dementia Web Pages
• isrctn registry

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Martin Orrell

  Director of the Institute of Mental Health

  STUDY DIRECTOR

Central Study Contacts

Justine Schneider

CONTACT

+44 (0)1158467307; Justine.Schneider@nottingham.ac.uk

Becky Dowson

CONTACT

+44 (0)115 74 84315; Becky.Dowson@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In pragmatic terms, masking or trial 'blinding' is not possible nor desirable for this study; instead we will aim to keep assessors and trial statistician in ignorance of participants' allocations, and to monitor success by asking assessors to judge those allocations \& their confidence therein.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-only participant groups comprising of those with dementia and carers. The sessions will be delivered by an experienced leader of singing in dementia, supported by volunteers, and an instrumentalist (guitar or piano). The intervention will be delivered on one day per week to 3 groups of up to 27 couples (not necessarily spouses) in each of which pairs one person has dementia. Singing will last 60 minutes, with 30 minutes for socialising before or after that. The intervention groups will start singing immediately; the control groups will wait 12-13 weeks before starting. The study will last about two years, with participant involvement expected to last between 12-15 months. The intervention will be delivered in three geographical areas, with a singing intervention group set up in each of these areas. The intervention groups may continue into the second round.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: October 10, 2022
• Study Start: August 19, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymised and non-identifiable data will only be shared during dissemination of findings.
• Access Criteria: Clinical and public access during dissemination of findings.

Locations

GB (2)