DREAMS START (Dementia RElAted Manual for Sleep) RCT
Research type
Research Study
Full 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)for people living with dementia and their carers
IRAS ID
272935
Contact name
Penny Rapaport
Contact email
ISRCTN Number
ISCTRN13072268
Duration of Study in the UK
3 years, 7 months, 30 days
Research summary
Why is this important?
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.What do we already know?
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. 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.What do we want to find out? 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. 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.
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.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
20/LO/0894
Date of REC Opinion
21 Aug 2020
REC opinion
Further Information Favourable Opinion