PMID- 31748300 OWN - NLM STAT- MEDLINE DCOM- 20201027 LR - 20201027 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 9 IP - 11 DP - 2019 Nov 19 TI - HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial. PG - e031332 LID - 10.1136/bmjopen-2019-031332 [doi] LID - e031332 AB - INTRODUCTION: Pharmacological interventions to address behavioural and psychological symptoms of dementia (BPSD) can have undesirable side effects, therefore non-pharmacological approaches to managing symptoms may be preferable. Past studies show that music therapy can reduce BPSD, and other studies have explored how formal caregivers use music in their caring roles. However, no randomised study has examined the effects on BPSD of music interventions delivered by informal caregivers (CGs) in the home setting. Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs. METHODS AND ANALYSIS: A large international three-arm parallel-group randomised controlled trial will recruit a sample of 495 dyads from Australia, Germany, UK, Poland and Norway. Dyads will be randomised equally to standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC for 12 weeks. The primary outcome is BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire). Secondary outcomes will examine relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes will be collected at baseline, at the end of the 12-week intervention and at 6 months post randomisation. Resource Utilisation in Dementia will be used to collect economic data across the life of the intervention and at 6-month follow-up. We hypothesise that the music programme plus SC will generate better results than SC alone (primary comparison) and the reading programme plus SC (secondary comparison). ETHICS AND DISSEMINATION: Ethical approval has been obtained for all countries. Results will be presented at national and international conferences and published in scientific journals and disseminated to consumer and caregiver representatives and the community. TRIAL REGISTRATION NUMBERS: ACTRN12618001799246p; NCT03907748. CI - (c) Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Baker, Felicity Anne AU - Baker FA AUID- ORCID: 0000-0002-9851-7133 AD - Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia felicity.baker@unimelb.edu.au. FAU - Bloska, Jodie AU - Bloska J AD - Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK. FAU - Braat, Sabine AU - Braat S AD - School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia. FAU - Bukowska, Anna AU - Bukowska A AD - Department of Occupational Therapy, University of Physical Education, Krakow, Poland. FAU - Clark, Imogen AU - Clark I AD - Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia. AD - Austin Health, Melbourne, Victoria, Australia. FAU - Hsu, Ming H AU - Hsu MH AD - Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK. FAU - Kvamme, Tone AU - Kvamme T AD - Centre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway. FAU - Lautenschlager, Nicola AU - Lautenschlager N AD - Department of Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia. AD - NorthWestern Mental Health, Melbourne Health, Melbourne, Victoria, Australia. FAU - Lee, Young-Eun Claire AU - Lee YC AD - Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia. AD - Austin Health, Melbourne, Victoria, Australia. FAU - Smrokowska-Reichmann, Agnieszka AU - Smrokowska-Reichmann A AD - Department of Occupational Therapy, University of Physical Education, Krakow, Poland. FAU - Sousa, Tanara Vieira AU - Sousa TV AD - School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia. FAU - Stensaeth, Karette A AU - Stensaeth KA AD - Centre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway. FAU - Tamplin, Jeanette AU - Tamplin J AD - Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia. AD - Austin Health, Melbourne, Victoria, Australia. FAU - Wosch, Thomas AU - Wosch T AD - Hochschule fur angewandte Wissenschaften Wurzburg-Schweinfurt, Wurzburg, Germany. FAU - Odell-Miller, Helen AU - Odell-Miller H AD - Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK. LA - eng SI - ClinicalTrials.gov/NCT03907748 SI - ANZCTR/ACTRN12618001799246p PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20191119 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Dementia/*nursing MH - Family MH - *Home Nursing MH - Humans MH - Multicenter Studies as Topic MH - *Music Therapy MH - Quality of Life MH - Randomized Controlled Trials as Topic MH - *Reading PMC - PMC6886975 OTO - NOTNLM OT - behavioural and psychological symptoms of dementia OT - caregivers OT - dementia OT - home-based interventions OT - music therapy OT - randomised controlled trial COIS- Competing interests: None declared. EDAT- 2019/11/22 06:00 MHDA- 2020/10/28 06:00 PMCR- 2019/11/19 CRDT- 2019/11/22 06:00 PHST- 2019/11/22 06:00 [entrez] PHST- 2019/11/22 06:00 [pubmed] PHST- 2020/10/28 06:00 [medline] PHST- 2019/11/19 00:00 [pmc-release] AID - bmjopen-2019-031332 [pii] AID - 10.1136/bmjopen-2019-031332 [doi] PST - epublish SO - BMJ Open. 2019 Nov 19;9(11):e031332. doi: 10.1136/bmjopen-2019-031332.