Introduction
dementia, BPSD
SECONDARY
The majority of people with dementia live in the community and not in residential care settings [Music therapy offers the potential to provide CGs with support in managing PwD. This therapy is a registered psychosocial National Health Service intervention in the United Kingdom (UK) to address the needs of people living with dementia [The HOME-based caregiver-delivered music intervention for people living with dementia (HOMESIDE) study is designed to examine the effectiveness of a music intervention (MI) in addition to standard care (SC) delivered directly by CGs in a home setting following training in the intervention delivery by music therapists. The aim of the HOMESIDE randomised controlled trial (RCT) is to demonstrate the effectiveness of the 12-week MI plus SC on the short-term BPSD at the end of the intervention of PwD living at home and being cared for by a cohabitating CG compared with SC (primary) and to evaluate the effectiveness of MI plus SC, compared with a reading intervention (RI) plus SC (secondary). The RI plus SC condition was chosen as an active control group as some evidence suggests reading to and with PwD can have a positive impact on BPSD [This paper describes the planned statistical analysis for the HOMESIDE trial and supersedes the plan provided in the trial registries and published protocol. Any changes to the statistical analysis plan between publishing and unmasking will be tracked. The final statistical analysis plan will be approved during the masked data review and signed before breaking the treatment allocation code, after which any changes will be considered post hoc.