Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/32977
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dc.contributor.authorPac Soo, Vanessa-
dc.contributor.authorBaker, Felicity A-
dc.contributor.authorSousa, Tanara Vieira-
dc.contributor.authorOdell-Miller, Helen-
dc.contributor.authorStensæth, Karette-
dc.contributor.authorWosch, Thomas-
dc.contributor.authorBukowska, Anna A-
dc.contributor.authorTamplin, Jeanette-
dc.contributor.authorLautenschlager, Nicola-
dc.contributor.authorBraat, Sabine-
dc.contributor.authorLamb, Karen E-
dc.date2023-
dc.date.accessioned2023-06-07T02:37:17Z-
dc.date.available2023-06-07T02:37:17Z-
dc.date.issued2023-05-08-
dc.identifier.citationTrials 2023-05-08; 24(1)en_US
dc.identifier.issn1745-6215-
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/32977-
dc.description.abstractMost 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. 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. 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. Australian New Zealand Clinical Trials Registry ACTRN12618001799246. Registered on November 05, 2018. gov NCT03907748. Registered on April 09, 2019.en_US
dc.language.isoeng-
dc.subjectDementiaen_US
dc.subjectMusic therapyen_US
dc.subjectRandomised controlled trialen_US
dc.subjectStatistical analysis planen_US
dc.titleStatistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleTrialsen_US
dc.identifier.affiliationCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia.en_US
dc.identifier.affiliationFaculty of Fine Arts and Music, The University of Melbourne, Melbourne, VIC, Australiaen_US
dc.identifier.affiliationNorthWestern Mental Health, Melbourne Health, Melbourne, VIC, Australia.en_US
dc.identifier.affiliationCambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.en_US
dc.identifier.affiliationCentre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway.en_US
dc.identifier.affiliationHochschule für angewandte Wissenschaften Würzburg-Schweinfurt, Würzburg, Germany.en_US
dc.identifier.affiliationInstitute of Applied Sciences, University of Physical Education, Kraków, Poland.en_US
dc.identifier.affiliationAustin Healthen_US
dc.identifier.affiliationAcademic Unit for Psychiatry of Old Age, Department of Psychiatry, Melbourne Medical School, The University of Melbourne, Melbourne, VIC, Australiaen_US
dc.identifier.affiliationCentre 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.en_US
dc.identifier.affiliationMethods and Implementation Support for Clinical Health (MISCH) Research Hub, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, VIC, Australia.en_US
dc.identifier.doi10.1186/s13063-023-07327-8en_US
dc.type.contentTexten_US
dc.identifier.orcid0000-0002-6276-6920en_US
dc.identifier.pubmedid37226214-
dc.description.volume24-
dc.description.issue1-
dc.description.startpage316-
dc.subject.meshtermssecondaryDementia/diagnosis-
dc.subject.meshtermssecondaryDementia/therapy-
local.name.researcherTamplin, Jeanette
item.openairetypeJournal Article-
item.cerifentitytypePublications-
item.grantfulltextnone-
item.fulltextNo Fulltext-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.languageiso639-1en-
crisitem.author.deptInstitute for Breathing and Sleep-
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