TaIlored ManagEment of Sleep (TIMES) for people with dementia or mild cognitive impairment: protocol for a feasibility cluster-randomised controlled trial

TIMES programme team (2026) TaIlored ManagEment of Sleep (TIMES) for people with dementia or mild cognitive impairment: protocol for a feasibility cluster-randomised controlled trial. Pilot and Feasibility Studies. ISSN 2055-5784

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Abstract

Background: People living with dementia (PLWD) and mild cognitive impairment (MCI), and their family carers, often experience sleep disturbance which can impair daily living and care. There are limited options for effective long-term pharmacological management of sleep disturbance, yet recent advances in non-pharmacological approaches offer promising alternatives. TIMES is a novel, complex intervention, which aims to improve wellbeing for PLWD/MCI and their carers in primary care, by developing whole-person, tailored care plans that optimise management of sleep disturbance in context. Methods: Two-arm cluster-randomised (1:1), single-blinded, feasibility trial in 10 general practice sites in England, recruiting 64 patient–carer dyad participants (32 intervention + 32 treatment as usual). Co-primary objectives are to assess the feasibility and acceptability of conducting a subsequent definitive cluster-randomised controlled trial (cRCT) of the TIMES intervention. Secondary objectives include assessing the ability to collect data to address putative primary and secondary outcomes of a definitive cRCT. We will collect participant demographics at screening, and the following outcome measures at baseline, 9 and 15 week follow-ups: Sleep Disorders Inventory (SDI); Epworth Sleepiness Scale (ESS); Activities of Daily Living assessed with the Disability Assessment for Dementia (ADL DAD); Dementia Quality of Life Measure (DEMQOL); EQ-5D 5 level (EQ-5D-5L); ICEpop Capability measure for older people aged ≥ 65 (ICECAP-O); Neuropsychiatric Inventory Questionnaire (NPI-Q); Client Service Receipt Inventory (CSRI); Telephone Montreal Cognitive Assessment (T-MoCA); patient medical records review; patient serious adverse events (SAEs). We will conduct Process Evaluation interviews and Discrete Choice Experiments to inform refinement of the intervention content and delivery. Discussion: Our findings will inform the refinement and delivery of a subsequent definitive cRCT that tests the clinical and cost-effectiveness of the TIMES intervention compared with usual care.

Item Type:	Article
Additional Information:	Data availability: The dataset supporting the conclusions of this article will be made available in the University of Exeter’s Open Research Exeter repository (https://ore.exeter.ac.uk/repository/).
Uncontrolled Keywords:	sleep disturbance,clinical trial,complex intervention,primary healthcare,decision support tool,tailored care,dementia,mild cognitive impairment
Faculty \ School:	Faculty of Medicine and Health Sciences > School of Health Sciences Faculty of Medicine and Health Sciences > Norwich Medical School Faculty of Science
UEA Research Groups:	Faculty of Medicine and Health Sciences > Research Centres > Mental Health and Social Care (fka Lifespan Health) Faculty of Medicine and Health Sciences > Research Groups > Dementia & Complexity in Later Life Faculty of Science > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre Faculty of Science > Research Groups > Statistics Faculty of Medicine and Health Sciences > Research Groups > Epidemiology and Public Health Faculty of Medicine and Health Sciences > Research Centres > Public Health Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care Faculty of Medicine and Health Sciences > Research Groups > Behavioural and Implementation Science for Health and Care
Depositing User:	LivePure Connector
Date Deposited:	30 Mar 2026 16:30
Last Modified:	05 Apr 2026 06:30
URI:	https://ueaeprints.uea.ac.uk/id/eprint/102654
DOI:	10.1186/s40814-026-01791-0

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