Home-Based Family Caregiver-Delivered Music And Reading Interventions for People Living With Dementia: An International Randomised Controlled Trial (HOMESIDE Trial)

Background: Music interventions provided by qualified therapists within residential aged care are effective at attenuating behavioural and psychological symptoms (BPSD) of people with dementia (PwD). The impact of music interventions on dementia symptom management when provided by family caregivers is unclear.  Methods: We implemented a community-based, large, pragmatic, international, superiority, single-masked randomised controlled trial to evaluate if caregiver-delivered music was superior to usual care alone (UC) on reducing BPSD of PwD measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q). The study included an active control (reading). People with dementia (NPI-Q score >6) and their caregiver (dyads) from one of five countries were randomly allocated to caregiver-delivered music, reading, or UC with a 1:1:1 allocation stratified by site. Caregivers received three online protocolised music or reading training sessions delivered by therapists and were recommended to provide five 30-minute reading or music activities per week (minimum twice weekly) over 90-days. The NPI-Q severity assessment of PwD was completed online by masked assessors at baseline, 90- (primary) and 180-days post-randomisation and analysed on an intention-to-treat basis using a likelihood-based longitudinal data analysis model.  Findings: Between 27 th  November 2019 and 7 th  July 2022, we randomised 432 eligible of 805 screened dyads (music n=143, reading n=144, UC n=145). There was no statistical or clinically important difference in the change from baseline BPSD between caregiver-delivered music (-0·15, 95% CI -1·41 to 1·10, p=0·81) or reading (-1·12, 95% CI -2·38 to 0·14, p=0·082) and UC alone at 90-days. No related adverse events occurred.  Interpretations: Music interventions and reading interventions delivered by trained caregivers in community contexts do not decrease enduring BPSD symptoms. Funding: National Health and Medical Research Council, Australia; The Research Council of Norway; Federal Ministry of Education and Research, Germany; National Centre for Research and Development, Poland; Alzheimer’s Society, UK. Trial Registration: ACTRN12618001799246 (Registered 5th November 2018); Clinical Trials.gov NCT03907748 (Registered 9th April 2019). Funding: This work was supported by the Joint Programs for Neurodegenerative Diseases (JPND), which includes joint funding from the National Health and Medical Research Council (GNT1169867), Norwegian Research Council (Project number 298995), Federal Ministry of Education and Research Germany (01ED1901), and The National Centre for Research and Development, Poland JPND/04/2019, and Alzheimer’s Society, UK (grant no. 462). In the UK, the study was supported by the NIHR Clinical Research Network. This study was commissioned by the World Health Organisation’s Arts and Health Division, Geneva, Switzerland. Declaration of Interest: All authors declared no conflicts of interest. Ethical Approval: The trial was approved by ethics committees at The University of Melbourne (no.1852845) and local approvals were obtained for each country.