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Tailored management of sleep (TIMES) for people with dementia or mild cognitive impairment

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 – a cluster randomised controlled definitive trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12777190
Enrollment
420
Registered
2026-01-16
Start date
2026-02-16
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, mild cognitive impairment, sleep disturbance Mental and Behavioural Disorders

Interventions

The TIMES intervention is an ongoing, clinical assessment and management support tool, in which a tailored health-plan is co-created by the patient-carer dyad and GP, and subsequently reviewed and (if

Sponsors

University of Exeter
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Patient participants (PLWD/MCI): 1. Aged =18 years 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. 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 6. Able to communicate in English sufficiently well to complete the outcome measures and questionnaires 7. Has capacity to provide informed consent OR has a personal or professional consultee who is able to provide favourable advice on the views and wishes of the PLWD/MCI lacking capacity in relation to their participation Carer participants: 1. Aged =18 years 2. Resides in England 3. Able to communicate in English sufficiently well to complete the outcome measures and questionnaires 4. Has capacity to provide informed consent 5. Has lived with, or has professional experience of, the person with dementia/MCI who they provide care for 6. Has completed a Sleep Disorders Inventory proxy assessment of the person with dementia/MCI they provide care for, resulting in a score (frequency x severity) =4 on at least one item (symptoms 1-7) 7. Is not already enrolled in the study with another patient participant (each carer participant can only take part once)

Exclusion criteria

Exclusion criteria: Patient participants (PLWD/MCI): 1. Deemed overburdened or has severe unstable (mental or physical) health problems 2. Unable to communicate even with augmentative and alternative communication support 3. Does not have a family or professional carer 4. Undergoing end of life care 5. Planned unavailability for >3 weeks during intervention and follow-up (i.e approximately next 4 months) Carer Participants: 1. Deemed overburdened or has severe unstable (mental or physical) health problems 2. Diagnosis or health condition that may impair their ability to complete outcome assessments, as determined by the carer 3. Planned unavailability for =4 weeks during intervention and follow-up (i.e. approximately next 4 months)

Design outcomes

Primary

MeasureTime frame
Sleep disorders in PLWD/MCI measured using the Sleep Disorders Inventory (SDI) for PLWD/MCI (Proxy-rated) at baseline, 9 weeks and 15 weeks

Secondary

MeasureTime frame
1. Daytime sleepiness is measured using the Epworth Sleepiness Scale (ESS) at baseline, 9 weeks and 15 weeks 2. Ability to perform basic and instrumental activities of daily living is measured using the Disability Assessment for Dementia (DAD) at baseline, 9 weeks and 15 weeks 3. Health-related quality of life is measured using the EQ-5D-5L at baseline, 9 weeks and 15 weeks 4. Wellbeing and quality of life in older people is measured using the ICECAP-O at baseline, 9 weeks and 15 weeks 5. Severity of neuropsychiatric symptoms and associated carer distress is measured using the Neuropsychiatric Inventory Questionnaire (NPI-Q) at baseline, 9 weeks and 15 weeks 6. Cognitive impairment is measured using the Telephone Montreal Cognitive Assessment (T-MoCA) Mini Version 2.1 English at baseline, 9 weeks and 15 weeks 7. Health care resource utilisation is measured using an adapted Client Service Receipt Inventory (CSRI) at baseline, 9 weeks and 15 weeks

Countries

England, United Kingdom

Contacts

Public ContactJayden van Horik
TIMES@exeter.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026