TY - JOUR A1 - Bukowska, Anna A. A1 - Janus, Edyta A1 - Soo, Vanessa Pac A1 - Smrokowska-Reichmann, Agnieszka A1 - Hsu, Ming Hung A1 - Stensæth, Karette A. A1 - Odell-Miller, Helen A1 - Tamplin, Jeanette A1 - Wosch, Thomas A1 - Sousa, Tanara Vieira A1 - Lamb, Karen E. A1 - Braat, Sabine A1 - Baker, Felicity A. T1 - Relationship between dementia diagnostic characteristics and severity of depressive symptoms in a cross-sectional analysis of HOMESIDE baseline data JF - Scientific Reports Y1 - 2025 U6 - https://doi.org/10.1038/s41598-025-20385-z SN - 2045-2322 VL - 15 IS - 1 PB - Springer Science and Business Media LLC ER - TY - JOUR A1 - Baker, Felicity Anne A1 - Pac Soo, Vanessa A1 - Bloska, Jodie A1 - Blauth, Laura A1 - Bukowska, Anna A. A1 - Flynn, Libby A1 - Hsu, Ming Hung A1 - Janus, Edyta A1 - Johansson, Kjersti A1 - Kvamme, Tone A1 - Lautenschlager, Nicola A1 - Miller, Hayley A1 - Pool, Jonathan A1 - Smrokowska-Reichmann, Agnieszka A1 - Stensæth, Karette A1 - Teggelove, Kate A1 - Warnke, Sven A1 - Wosch, Thomas A1 - Odell-Miller, Helen A1 - Lamb, Karen A1 - Braat, Sabine A1 - Sousa, Tanara Vieira A1 - Tamplin, Jeanette T1 - Home-based family caregiver-delivered music and reading interventions for people living with dementia (HOMESIDE trial): an international randomised controlled trial JF - eClinicalMedicine Y1 - 2023 U6 - https://doi.org/10.1016/j.eclinm.2023.102224 SN - 2589-5370 VL - 65 PB - Elsevier BV ER - TY - JOUR A1 - Pac Soo, Vanessa A1 - Baker, Felicity A. A1 - Sousa, Tanara Vieira A1 - Odell-Miller, Helen A1 - Stensæth, Karette A1 - Wosch, Thomas A1 - Bukowska, Anna A. A1 - Tamplin, Jeanette A1 - Lautenschlager, Nicola A1 - Braat, Sabine A1 - Lamb, Karen E. T1 - Statistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia JF - Trials N2 - Abstract 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. Y1 - 2023 U6 - https://doi.org/10.1186/s13063-023-07327-8 SN - 1745-6215 VL - 24 IS - 1 PB - Springer Science and Business Media LLC ER -