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
ISRCTN Number
ISRCTN54051676
Clinicaltrials.gov Identifier
NIHR Funder number, NIHR202345
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
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.
Summary of results:
The TIMES study was funded by the NIHR, Sponsored by the University of Exeter, coordinated by the Exeter Clinical Trials Unit, and delivered in Primary Care practices by GP’s, in England, UK.
Public involvement, from carers with lived experience and people living with dementia and MCI, and representative organisations (Innovations in Dementia, Together in Dementia Everyday and Chinese Wellbeing) were involved in all stages of the study, and provided central guidance and support on the development of participant facing materials and study implementation. The TIMES intervention was also co-designed through a series of workshops, by people with lived experience, GP’s, healthcare professionals, academics, and sleep experts.
The study took place in 10 GP practices throughout England, between 08-Aug-2024 – 25-Jun-2025, and 23 patient-carer participants took part.The research was needed to determine whether it would be feasible to recruit patients, collect data to assess any changes in health outcomes, and whether participation in the TIMES intervention was acceptable. These data will be used to design a larger full-scale trial that will test the effectiveness of the TIMES intervention.
Findings from this study showed reasonable participant recruitment, excellent data completion and intervention participation. These results informed the decision from an independent steering committee, funder and Sponsor, to support progression to a larger full-scale Definitive trial.
The TIMES Definitive trial is currently being delivered in England, with a target of 66 GP practices and 420 patient-carer participants involved.More information about TIMES can be found here: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fconnectedageing.org%252F%2FNBTI%2FyyPGAQ%2FAQ%2F09414eab-c114-4f4a-a344-0864c5d3db5a%2F2%2FuWw9K-JXna&data=05%7C02%7Charrow.rec%40hra.nhs.uk%7C7a63181a65544127627508decde796e7%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639174591715343083%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=zCOM6decSNbqlyQ9gVtHkVmoEFELsEc0jVx5Nnkpyvs%3D&reserved=0
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