TIMES – TaIlored ManagEment of Sleep – Feasibility 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 and sleep disturbance – A Cluster Randomised Feasibility Trial
IRAS ID
330115
Contact name
Chris Fox
Contact email
Sponsor organisation
University of Exeter
Clinicaltrials.gov Identifier
NIHR202345, NIHR Funder number
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
We are testing the feasibility of an intervention to improve the tailored assessment and management of sleep problems in people living with dementia (PLWD) and 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 control 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 problems. 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 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 look at whether the TIMES intervention is feasible, and help inform the design of a separate, larger, randomised trial in the future.
REC name
London - Harrow Research Ethics Committee
REC reference
24/LO/0123
Date of REC Opinion
15 Mar 2024
REC opinion
Further Information Favourable Opinion