Tailored sleep management for people living with dementia and mild cognitive impairment

INTERVENTION: Trial design: ‐ Feasibility study: to see if the intervention is acceptable to participants and GPs, sufficient numbers of participants can be recruited and engaged with the intervention, and sufficient data can be collected to assess improvement in sleep, general health and wellbeing, and economic evaluation. ‐ Two‐Arm: There are two treatment groups, one will receive the intervention and the other will receive treatment as usual (control) ‐ Single‐blinded: research practitioners collecting participant‐reported outcome measures will not know which arm participants are allocated to GPs and participants will know which group they are in. ‐ Multi‐centre: recruiting 8 GP practices. ‐ Cluster‐Randomised Controlled Trial: Once all 8 participating GP Practices (sites) have been identified to participate in the study, half of them will be randomly allocated using a block design to deliver the intervention and the other half will deliver treatment as usual. Randomisation is therefore clustered by site, rather than at the participant level. This method allows more effective delivery of the intervention as GPs in the control group will not receive TIMES intervention training or access to the intervention materials. ‐ Comple XIntervention: allows flexibility in how the intervention is delivered as it needs to be tailored to individual participants, based on their specific needs. ‐ Participants: People living with dementia or mild cognitive impairment (PLWD/MCI), in primary care, who have a paid or unpaid carer to support them, and who have sleep problems. 64 patient‐carer pairs will be recruited in total, half will receive the intervention and the other half treatment as usual. Recruitment: ‐ Pre‐Screening‐ Patient medical records from their GP practice are used to identify patien CONDITION: Dementias and neurodegeneration ; Mental and Behavioural Disorders SECONDARY OUTCOME: The following secondary outcome measures are assessed at baseline, and the 9‐ and 15‐week follow‐ups:; 1. Day‐time sleeping/dozing behaviour measured using the Epworth sleepiness scale (ESS); 2. Daily living measured using the Activities of Daily Living (ADL): Assessed with the Disability Assessment for Dementia (DAD); 3. Quality of life measured using the Dementia Quality of Life Measure (DEMQOL); 4. Wellbeing measured using the EQ‐5D 5 level; 5. Wellbeing and quality of life measured using the ICEpop Capability measure (ICECAP‐O); 6. Neuropsychiatric symptoms measured using the Neuropsychiatric Inventory Questionnaire (NPI‐Q); 7. Health and social care service use measured using the Client Service Receipt Inventory (CSRI); 8. Non‐visual cognitive assessment completed over the phone using the Telephone Montreal Cognitive Assessment (T‐MoCA) PRIMARY OUTCOME: This is a Feasibility study that is aimed at determining whether a subsequent full‐scale definitive trial should proceed. ; Feasibility trial outcome measures are measured using data collected in study records:; 1. The proportion of people in a primary care setting who meet the following criteria (per 1000 registered patients):; 1.1. PLWD/MCI with problematic sleep disturbance; 1.2. PLWD/MCI with problematic sleep disturbance who also have a professional or family carer; 1.3. PLWD/MCI with problematic sleep disturbance who also have a professional or family carer and meet other trial eligibility criteria; 2. The proportion of eligible people who consent to participate in the study; 3. The proportion of consented participants in the intervention arm who start the intervention; 4. The proportion of consented participants in the intervention arm, who start the intervention and complete all three stages of the intervention: Assessment in Context (SADL); Co‐created Tailored Plan consultation; and Review and Revise consultation; 5. The proportion of consented participants who remain in the study until final follow‐up at 15 weeks; 6. The proportion of consented participants who remain in the study and provide valid outcome data for clinical and health‐economic measures, including the putative primary outcome for a definitive trial (see below) at 9‐ and 15‐week follow‐ups; 7. The acceptability of the intervention as assessed through the process evaluation using an online or in‐person interview and an online survey at the end of the study; 8. Mean and standard deviation, plus between‐group mean difference with 95% confidence interval and Intraclass Correlation Coefficient (ICC) for the proposed primary outcome of the definitive trial (and any proposed outcomes that may be key secondary outcomes for which a power calculation is performed), used to verify or revise the proposed primary outcome and sample size calculation for the definitive RCT ; ; Proposed Clinical Outcome Measures for a Definitive Trial:; Primary Outcome: Sleep disorders measured using the Sleep Disorders Inventory (SDI) at Screening, and the 9‐ and 15‐week follow‐ups INCLUSION CRITERIA: Patient participants (PLWD/MCI): 1. Aged >18 years old 2. Clinical diagnosis of dementia/MCI of any subtype and stage 3. In primary care and registered with a participating general practice 4. Residing at home or in a community care home in England 5. Has sleep problems of any type that are considered problematic by the PLWD/MCI, their family or carer 6. Have a family or professional carer who provides support at least one hour per week and is willing to solely assist with completion of outcomes (see section 6.2 carer definition) 7. Able to communicate in English sufficiently well to complete the outcome measures and questionnaires 8. Has the capacity to provide informed consent OR has a personal or professional consultee who is able to provide favourable opinion on behalf of the PLWD/MCI Carer participants: 1. Aged >18 years old 2. Resides in England 3. Able to communicate in English sufficiently well to complete the ou