Title: 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)
Funder: Department of Health and Social Care

Abstract: Why is this important?_x000D_ Many people living with dementia have disturbed sleep, including reduced night-time sleep, night-time wandering and daytime sleepiness. They often wake family members, who may become exhausted, stressed and unhappy. Night-time paid care may be unaffordable and care at home may break down. _x000D_ _x000D_ What do we already know?_x000D_ There are currently no known effective, safe treatments for sleep problems in people with dementia, possibly because there may be many causes even in the same person. These include brain changes from dementia, worry and physical pain. Therefore, we would not expect any single treatment, except possibly sleeping tablets, to work. Sleeping tablets, however, have not been found to work for people with dementia, but do increase falls and hospital admissions. Our team of experts - in sleep, dementia interventions, and people whose lives have been affected by dementia - developed DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) using the best evidence and what people felt was important to them. It has six-sessions, working with family members, to improve sleep for people living with dementia. It uses several approaches; such as increasing light, activity, comfort, routine and relaxation. We use it flexibly, based on what someone needs and what works for them. We train and supervise health workers with a psychology degree to deliver DREAMS START. They deliver it to family carers individually at home (people with dementia can also join sessions) and together they work out and try ideas to improve their relative’s sleep._x000D_ _x000D_ We completed a small study to see if DREAMS START was feasible (if people agreed to take part) and acceptable (if people completed and liked it); comparing people with dementia who received it with those who had usual treatment without DREAMS START. It was feasible and effective, as about two-thirds of people approached agreed to participate (62), and about 90% finished the six-sessions; nearly all liked it. Most people taking part were from memory services. It appeared promising in improving sleep. Participants made suggestions for future improvements. _x000D_ _x000D_ What do we want to find out?_x000D_ Our first question is does DREAMS START work: “Do people with dementia living at home sleep better 8 months after receiving DREAMS START compared to people who do not receive it?” We also want to know if it works at 4 months (just after the intervention), if it improves quality of life, is good value, helps families and, if it works, how it works._x000D_ We have worked out we need 370 people to answer our first question. We will recruit from five varied NHS sites for a randomised trial. Randomised means a computer decides who has DREAMS START and who only has the treatment they would get anyway. We will make small changes to DREAMS START (e.g. offering it either weekly or two weekly, rather than only weekly; and using a text reminder service) based on advice from our earlier study. We will ask family carers to rate their relatives’ sleep on a widely used well-tested questionnaire (Sleep Disorders Inventory) which family carers found clear and relevant in our earlier study. _x000D_ _x000D_ If DREAMS START works, it will mean services can offer an effective treatment to improve the lives of people with dementia and their families. We will work with people affected by dementia and sleep disturbances, and service providers, throughout the project to ensure potential benefits can be widely rolled out.

Lay abstract: Research question _x000D_ 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)._x000D_ _x000D_ Background _x000D_ 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._x000D_ _x000D_ Objectives_x000D_ 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. _x000D_ Secondary - to determine if it: _x000D_ 1. Is cost-effective._x000D_ 2. Is effective at 4m. _x000D_ 3. Improves people with dementia and family carers’ quality of life. _x000D_ 4. Improves family carers’ sleep, affective symptoms and burden. _x000D_ 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._x000D_ _x000D_ Methods _x000D_ 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. _x000D_ Settings: Memory clinics and primary care through five mental health trusts._x000D_ 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._x000D_ Primary outcome (8m): SDI _x000D_ 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. _x000D_ Family carer - burden (ZBI), sleep disturbance (SCI), mood (HADS) and quality of life (HSQ) and EQ5D 5L._x000D_ 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._x000D_ _x000D_ Timelines for delivery _x000D_ WP1 Set up (1-5m): Site initiation, staff recruitment and training, intervention adaptation. _x000D_ WP2 RCT (6-37m) with internal pilot (6-15m)reporting in month 15. _x000D_ WP3 Mixed methods process evaluation (15-42m). _x000D_ WP4 Analysis, write up and dissemination (37-44m). _x000D_ _x000D_ Anticipated impact and dissemination _x000D_ Impact and benefit for: _x000D_ 1. People living with dementia and their families._x000D_ 2. Academia: building academic capacity and scientific knowledge even if ineffective._x000D_ 3. Those implementing and commissioning health and social care. _x000D_ _x000D_ We will achieve this through implementation toolkits, peer-reviewed publications, dissemination events and targeted engagement.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: NEUROLOGICAL