Statistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia

Trials

Update

Nicola Lautenschlager¹  Helen Odell-Miller²  Sabine Braat³  Vanessa Pac Soo³  Karen E. Lamb³  Karette Stensæth⁴  Tanara Vieira Sousa⁵  Jeanette Tamplin⁶  Felicity A. Baker⁷  Thomas Wosch⁸  Anna A. Bukowska⁹ 

[1] Academic Unit for Psychiatry of Old Age, Department of Psychiatry, Melbourne Medical School, The University of Melbourne, Melbourne, VIC, Australia;NorthWestern Mental Health, Melbourne Health, Melbourne, VIC, Australia;Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK;Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia;Methods and Implementation Support for Clinical Health (MISCH) Research Hub, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, VIC, Australia;Centre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway;Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, VIC, Australia;Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, VIC, Australia;Austin Health, Melbourne, VIC, Australia;Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, VIC, Australia;Centre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway;Hochschule für angewandte Wissenschaften Würzburg-Schweinfurt, Würzburg, Germany;Institute of Applied Sciences, University of Physical Education, Kraków, Poland;

关键词: Dementia;    Music therapy;    Statistical analysis plan;    Randomised controlled trial;   

DOI  :  10.1186/s13063-023-07327-8

 received in 2023-01-17, accepted in 2023-04-24,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundMost 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 analysisHOMESIDE 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001799246. Registered on November 05, 2018. ClinicalTrials.gov NCT03907748. Registered on April 09, 2019.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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