Title: The clinical, social and cost effectiveness of a decision support tool to optimise community-based tailored management of sleep (TIMES) for people living with dementia or mild cognitive impairment and sleep disturbanceTIMES –TaIlored ManagEment of Sleep
Funder: Department of Health and Social Care

Abstract: Research Questions: What are the key factors influencing interpretation of sleep disturbance and so clinical decision making by clinicians, patients and carers in dementia or MCI? What are in-practice enablers/barriers to tailored sleep management? What should be included in the intervention, who should deliver it and how? Is a randomised controlled trial (RCT) of this intervention feasible? Is a system-embedded tailored sleep management tool to improve outcomes of PLWD/MCI and sleep disturbance clinically and economically effective to implement from a health and personal social service perspective? Which intervention components provide benefit for which groups in dementia and MCI? Background: In the UK, there are 850,000 PLWD and 2.4 million people with MCI. Sleep problems are common in PLWD (20-90%) and MCI (18.3&ndash;45.5%).57,58 There are no licensed medications for this and medicines used have harms. Sleep management in PLWD and MCI is a wicked design problem because the problem is complex, the knowledge required to understand and address it includes multiple disciplines and subject expertise, and because interventions do not fix but support best management in context. 6,8,59 Aims: We will develop and test a tool (TIMES) to help primary-care clinicians working with patients/carers to implement tailored decisions on sleep management for PLWD/MCI. Objectives: To develop a tailoring sleep management tool that enables community-based clinicians to optimise the tailored care of PLWD or MCI and sleep disorders, and their carers. Co-design structure and implementation of TIMES Test the feasibility of TIMES Test TIMES in a cluster RCT with internal pilot Evaluate TIMES costs and benefits from an NHS & Personal Social Services (PSS) perspective Methods: WP 1 refines the conceptual framework for a new complex intervention. WP 2 uses co-production methods to translate known components of tailored care (from literature and professional practice) for the tailored management of sleep in the UK context. WP3 2-arm cluster randomised feasibility trial, in 8 general practice sites, recruiting 64 participants (patients and carers) (32 intervention 32 control) over 5 months. Participants, seen in primary care, will receive the TIMES intervention or receive treatment as usual. We will test recruitment, retention and outcomes (patients: sleep duration/quality, behaviour, quality of life and medication usage, carers; sleep, mood and anxiety, burden, quality of life). WP4 2-arm cluster randomised controlled trial of clinical and cost effectiveness, in 110 general practices recruiting an estimated sample size of 495 over 13 months, designed with information from WP3 feasibility study. Timelines for delivery: The programme is over 60 months, development, co-design and refinement take place up to month 22, the implementation study months 1-54, CRCTs months 19&ndash;54. Dissemination activities take place throughout as work-packages report with final trial results and final report months 54-60. Anticipated impact and dissemination: Potential is for widespread impact due to the fundamental health importance of sleep, the particular management problems for people with dementia/MCI their families and limited options in primary care. We will approach dissemination proactively, engaging with academic, policy, professional/practitioner and lay audiences.

Lay abstract: What is the problem? Sleep disturbance often affects daily living for people living with dementia or memory problems and can make it difficult for carers to cope. People often ask their doctor for medicines to help with sleep. Help needs to be tailored to the individual. Many different things can upset sleep. Medicines help some people, but sleep medicines used long-term can be harmful or stop working. For some people, non-medicine treatments, given either on their own or in combination with tablets, may be better. Different people need different approaches to help. Doctors, patients and carers should work together for the best tailored care but have told us they need help to do that. What we will do? Our research will develop and test a tool to help patients, carers and professionals produce tailored care plans that meet the sleep-related needs of people with dementia or memory problems and their carers, whilst reducing harm from sleeping medicines. From previous research we know of some, but not all, the elements a tool would need (Figure 1). We will fill in the gaps using new research that gathers expertise from patients, carers and professionals and from existing research on tailoring care for sleep. We will share our findings with patients, carers and staff so we can work together to design a tool that supports a tailored approach to managing sleep in primary care. We will test the tool using a small trial of 64 people across eight sites in England to understand whether it can work. If the small trial is successful we will run a large trial to tell us whether the new tool is helpful for patients and carers. What will this mean? We hope to improve health and wellbeing for people with dementia or memory problems who also have sleep problems, and for their carers. What do patients and carers want? People with dementia (from DEEP and Alzheimer s Society) and their families and carers (from TIDE) met with us in focus groups and told us that sleep problems matter to them. They helped develop our idea about the importance of tailored care and have told us they want to continue to work with us to complete the research. How will we share findings? We will produce summaries for different audiences. DEEP, Alzheimer s Society and TIDE members will help us prepare and share resources videos for patients and carers that help them access tailored sleep care. We will inform professionals through academic and professional journals, conferences, events, and social media. We will hold workshops for people with dementia or memory problems, carers, prescribers, and people who decide on and provide health and social care services, to share our findings.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;7.3 MANAGEMENT AND DECISION MAKING
Health categories: NEUROLOGICAL