A parallel multi-centre randomised controlled trial to determine the clinical and cost-effectiveness of DREAMS START(Dementia RElAted Manual for Sleep; STrAtegies for RelaTives)

Research question Does DREAMS START improve sleep disturbance for people living with dementia in their own homes and their family carers compared to treatment as usual (TAU). Background About 40% of people living with dementia have sleep disturbances and there are no known effective treatments. Family carers find this may lead to interruption of their own sleep, low mood, and breakdown of care at home. Our DREAMS-START feasibility study found the intervention delivered individually to family carers by supervised graduate facilitators, and study design, were acceptable and feasible. It is an evidence based, manualised treatment, with information about sleep and dementia. It supports carers to use cues to influence circadian rhythms, including light and activity, to establish pre-bed settling routine and night de-arousal. Objectives Primary: To determine if DREAMS START improves sleep disturbances in people living with dementia at home at 8 months(m) compared to TAU, measured on Sleep Disorder Inventory (SDI) a valid proxy measure. Secondary - to determine if it: 1. Is cost-effective. 2. Is effective at 4m. 3. Improves people with dementia and family carers’ quality of life. 4. Improves family carers’ sleep, affective symptoms and burden. We will also investigate whether mechanisms of any changes are increases in patient’s daytime movement and light exposure; and if effective, how we can optimise the intervention for NHS implementation at scale. Methods Design: Multi-centre parallel group superiority randomised controlled trial (RCT) with masked outcome assessment. Participants (power calculation n=370) randomised 1:1 to intervention or TAU. We will conduct an internal pilot and process evaluation. Settings: Memory clinics and primary care through five mental health trusts. Participants: People with a clinical diagnosis of dementia with sleep disturbances (scoring 4 on any SDI item and judged by them or family as a problem) living in their own homes and their primary family carer. Primary outcome (8m): SDI Secondary outcomes (4m and 8m): Person with dementia - Cost-effectiveness: Client Service Receipt Inventory (CSRI) and EQ5D 5L proxy; SDI (8m), quality of life (DEMQOL-Proxy), neuropsychiatric symptoms (NPI), daytime somnolence (ESS), medication use, side effects. Family carer - burden (ZBI), sleep disturbance (SCI), mood (HADS) and quality of life (HSQ) and EQ5D 5L. Process evaluation: We will record intervention attendance and rate therapist fidelity. After 8m outcomes, we will conduct qualitative interviews with 15-20 participants and 5 staff delivering the intervention. We will collect person with dementia’s one-week actigraphy (Axivity AX3) baseline and pre-8m assessment to explore potential change mechanisms. Timelines for delivery WP1 Set up (1-5m): Site initiation, staff recruitment and training, intervention adaptation. WP2 RCT (6-37m) with internal pilot (6-15m)reporting in month 15. WP3 Mixed methods process evaluation (15-42m). WP4 Analysis, write up and dissemination (37-44m). Anticipated impact and dissemination Impact and benefit for: 1. People living with dementia and their families. 2. Academia: building academic capacity and scientific knowledge even if ineffective. 3. Those implementing and commissioning health and social care. We will achieve this through implementation toolkits, peer-reviewed publications, dissemination events and targeted engagement.