TIMES – A Cluster Randomised Controlled Definitive Trial
Research type
Research Study
Full 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 – A Cluster Randomised Controlled Definitive Trial
IRAS ID
355061
Contact name
Chris Fox
Contact email
Sponsor organisation
University of Exeter
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
We are testing the effectiveness of an intervention to improve the tailored assessment and management of sleep in people living with dementia (PLWD) or mild cognitive impairment (MCI).
Sleep problems often affect PLWD and MCI, and can cause carers stress and fatigue. Sleep problems are difficult to assess and manage well in primary care, and GPs require more support and guidance. Sleep medicines are often relied on and help some people, but these can also be harmful or stop working if used long-term. For some people, non-medicine treatments, given either on their own or in combination with medication, may be a better approach. Help needs to be tailored, meaning that GPs, patients, and carers should work together to find the best solution. Using expertise from people with lived experience and healthcare professionals, we have co-designed an intervention (TIMES) to help GPs develop and deliver a tailored care-plan to better assess and manage sleep problems for PLWD/MCI.
This study is a randomised controlled trial, meaning that some participants will receive the TIMES intervention, and others will receive treatment as usual. PLWD/MCI and their carers who receive the TIMES intervention will complete a short questionnaire about their sleep. This will be used by their GP to help them develop a tailored care plan. PLWD/MCI and their carers will then receive a 30-minute in-person consultation with their GP to co-develop their care plan, which will be reviewed during a second consultation 15-minute consultation, one month later. A clinical researcher will contact all participants at 9- and 15-weeks, either over the phone or in person, to collect information about their sleep and general health and wellbeing.This study will test the effectiveness, and cost effectiveness, of the TIMES intervention compared to treatment as usual.
REC name
Wales REC 3
REC reference
25/WA/0327
Date of REC Opinion
19 Nov 2025
REC opinion
Favourable Opinion