Pilot Randomised Evaluation of Singing in Dementia (PRESIDE): protocol for a two-arm, parallel group randomised controlled feasibility study with waiting-list control

Abstract

BackgroundAs the number of people living with dementia grows, so does the need to provide them with adequate psychosocial support. Many people with dementia live at home with family carers, who also require social and emotional support to cope with their role. Community group singing has received attention for its potential to support people with dementia and their carers. It is postulated that singing can improve cognitive function, strengthen the bonds between care partners, and help to establish social support networks. However, there is a lack of rigorous evidence of singing’s benefits for this population. This study aims to test the feasibility of a randomised controlled trial of community singing in dementia, to pave the way for a larger, conclusive study.MethodsThe PRESIDE study is designed as a two-arm, parallel group randomised trial with a waiting list control. Dyads consisting of a person with dementia (n=80) and their carer (n=80) will be recruited. Each dyad will be randomised either to attend 10 weeks of community group singing sessions straight away, or to wait for three months before attending the sessions. The singing sessions will be led by experienced professional musicians and will last about 90 minutes, including time for socialising. The primary outcome of this study is the attainment of feasibility criteria around recruitment, retention and the acceptability of the waiting list control. Secondary outcomes include the quality of life, mood, cognition, and musical engagement of the person with dementia, and quality of life, mood, and experiences/challenges of the carer. These data will be collected during home visits at baseline, and three and six months post-baseline. DiscussionDespite growing public interest in the positive effects of singing, and encouraging findings from qualitative and non-randomised quantitative studies, there is a lack of rigorous evidence. This is the first randomised controlled trial of community group singing for people with dementia in Europe, to our knowledge. If the results favour a full trial, conclusively demonstrating the effectiveness of group singing could positively affect the opportunities available to community-dwelling people with dementia and their carers.Trial RegistrationUnique identification number in ISRCTN registry: ISRCTN10201482 https://www.isrctn.com/ISRCTN10201482. Date registered: 12/05/2020