TaIlored ManagEment of Sleep (TIMES) for people with dementia and mild cognitive impairment in primary care in England: protocol for a feasibility cluster-randomised controlled trial

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. TRIAL REGISTRATION: This study received approval from the Health Research Authority (HRA) and London-Harrow Research Ethics Committee (Reference: 24/LO/0123), and is sponsored by the University of Exeter (Reference: 2021-22-38). TRIAL REGISTRATION: ISRCTN, ISRCTN54051676, registered 20 March 2024, https://www.isrctn.com/ISRCTN54051676.