PMID- 37226214 OWN - NLM STAT- MEDLINE DCOM- 20230526 LR - 20230526 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 24 IP - 1 DP - 2023 May 8 TI - Statistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia. PG - 316 LID - 10.1186/s13063-023-07327-8 [doi] LID - 316 AB - BACKGROUND: Most people with dementia live in the community, not in residential care. Therefore, quality informal care for them is critical for managing behavioural and psychological symptoms of dementia (BPSD). Music therapy has been shown to reduce BPSD. However, no randomised controlled trial has examined the effects of music interventions delivered by caregivers in home settings. The HOME-based caregiver-delivered music intervention for people living with dementia (HOMESIDE) trial aims to evaluate the effectiveness of a 12-week music intervention in addition to standard care for BPSD. This article describes the statistical analysis plan. METHODS AND ANALYSIS: HOMESIDE is a large, pragmatic international three-arm parallel-group randomised controlled trial. Dyads (persons with dementia and caregiver) in Australia, Germany, the UK, Poland and Norway were randomised to receive music and standard care, reading and standard care or standard care alone. The primary outcome is BPSD (proxy) of the person living with dementia, measured using the Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 90 and 180 days post-randomisation. Longitudinal analysis will compare NPI-Q severity between music and standard care versus standard care alone. Secondary outcomes include quality of life and depression (both person with dementia and caregiver), cognition (person with dementia only), distress, resilience, competence and caregiver-patient relationship (caregiver only). Treatment effects will be obtained at 90 and 180 days post-randomisation, where applicable. Safety outcomes (adverse events, hospitalisations, deaths) will be summarised. DISCUSSION: This statistical analysis plan provides a detailed methodology for the analysis of HOMESIDE and will improve the validity of the study and reduce the potential for bias. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618001799246. Registered on November 05, 2018. CLINICALTRIALS: gov NCT03907748. Registered on April 09, 2019. CI - (c) 2023. The Author(s). FAU - Pac Soo, Vanessa AU - Pac Soo V AUID- ORCID: 0000-0002-6276-6920 AD - Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia. v.pacsoo@unimelb.edu.au. AD - Methods and Implementation Support for Clinical Health (MISCH) Research Hub, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, VIC, Australia. v.pacsoo@unimelb.edu.au. FAU - Baker, Felicity A AU - Baker FA AD - Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, VIC, Australia. AD - Centre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway. FAU - Sousa, Tanara Vieira AU - Sousa TV AD - Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, VIC, Australia. FAU - Odell-Miller, Helen AU - Odell-Miller H AD - Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK. FAU - Stensaeth, Karette AU - Stensaeth K AD - Centre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway. FAU - Wosch, Thomas AU - Wosch T AD - Hochschule fur angewandte Wissenschaften Wurzburg-Schweinfurt, Wurzburg, Germany. FAU - Bukowska, Anna A AU - Bukowska AA AD - Institute of Applied Sciences, University of Physical Education, Krakow, Poland. FAU - Tamplin, Jeanette AU - Tamplin J AD - Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, VIC, Australia. AD - Austin Health, Melbourne, VIC, Australia. FAU - Lautenschlager, Nicola AU - Lautenschlager N AD - Academic Unit for Psychiatry of Old Age, Department of Psychiatry, Melbourne Medical School, The University of Melbourne, Melbourne, VIC, Australia. AD - NorthWestern Mental Health, Melbourne Health, Melbourne, VIC, Australia. FAU - Braat, Sabine AU - Braat S AD - Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia. AD - Methods and Implementation Support for Clinical Health (MISCH) Research Hub, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, VIC, Australia. FAU - Lamb, Karen E AU - Lamb KE AD - Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia. AD - Methods and Implementation Support for Clinical Health (MISCH) Research Hub, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, VIC, Australia. LA - eng SI - ClinicalTrials.gov/NCT03907748 GR - GNT1169867/Joint Programs for Neurodegenerative Diseases and the National Health and Medical Research Council/ GR - 298995/Norwegian Research Council/ GR - 01ED1901/Federal Ministry of Education and Research Germany/ GR - JPND/04/2019/The National Centre for Research and Development, Poland/ GR - 462/The National Centre for Research and Development at Alzheimer's Society, UK/ PT - Journal Article PT - Randomized Controlled Trial DEP - 20230508 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Humans MH - *Music MH - Caregivers MH - Australia MH - Quality of Life MH - Reading MH - *Dementia/diagnosis/therapy PMC - PMC10208194 OTO - NOTNLM OT - Dementia OT - Music therapy OT - Randomised controlled trial OT - Statistical analysis plan COIS- The authors declare that they have no competing interests. EDAT- 2023/05/25 01:07 MHDA- 2023/05/26 06:42 PMCR- 2023/05/08 CRDT- 2023/05/24 23:51 PHST- 2023/01/17 00:00 [received] PHST- 2023/04/24 00:00 [accepted] PHST- 2023/05/26 06:42 [medline] PHST- 2023/05/25 01:07 [pubmed] PHST- 2023/05/24 23:51 [entrez] PHST- 2023/05/08 00:00 [pmc-release] AID - 10.1186/s13063-023-07327-8 [pii] AID - 7327 [pii] AID - 10.1186/s13063-023-07327-8 [doi] PST - epublish SO - Trials. 2023 May 8;24(1):316. doi: 10.1186/s13063-023-07327-8.