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

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.

Immediate impact of stay-at-home orders to control COVID-19 transmission on socioeconomic conditions, food insecurity, mental health, and intimate partner violence in Bangladeshi women and their families: an interrupted time series.

BACKGROUND: Stay-at-home orders (lockdowns) have been deployed globally to control COVID-19 transmission, and might impair economic conditions and mental health, and exacerbate risk of food insecurity and intimate partner violence. The effect of lockdowns in low-income and middle-income countries must be understood to ensure safe deployment of these interventions in less affluent settings. We aimed to determine the immediate impact of COVID-19 lockdown orders on women and their families in rural Bangladesh. METHODS: An interrupted time series was used to compare data collected from families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown. We also assessed women's experiences of intimate partner violence during the pandemic. RESULTS: Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent. 2414 (99·9%, 95% CI 99·6-99·9) of 2417 mothers were aware of, and adhering to, the stay-at-home advice. 2321 (96·0%, 95·2-96·7) of 2417 mothers reported a reduction in paid work for the family. Median monthly family income fell from US$212 at baseline to $59 during lockdown, and the proportion of families earning less than $1·90 per day rose from five (0·2%, 0·0-0·5) of 2422 to 992 (47·3%, 45·2-49·5) of 2096 (p<0·0001 comparing baseline with lockdown period). Before the pandemic, 136 (5·6%, 4·7-6·6) of 2420 and 65 (2·7%, 2·1-3·4) of 2420 families experienced moderate and severe food insecurity, respectively. This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001). Mothers' depression and anxiety symptoms increased during the lockdown. Among women experiencing emotional or moderate physical violence, over half reported it had increased since the lockdown. INTERPRETATION: COVID-19 lockdowns present significant economic, psychosocial, and physical risks to the wellbeing of women and their families across economic strata in rural Bangladesh. Beyond supporting only the most socioeconomically deprived, support is needed for all affected families. FUNDING: National Health and Medical Research Council, Australia.