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

Not Applicable

• Conditions: Dementias and neurodegeneration; Mental and Behavioural Disorders

• Registration Number: ISRCTN54051676
• Lead Sponsor: niversity of Exeter

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-20
• Last Update Posted: 1 April 2024
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 64

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 outcome measures and questionnaires
4. Has the capacity to provide informed consent
5. Has lived- or professional-experience of sleep disturbance of the PLWD/MCI who they provide care for
6. Has completed a Sleep Disorders Inventory proxy assessment of the PLWD/MCI they provide care for, resulting in a score (frequency x severity) >4 on at least one item (symptoms 1-7), as indicative of a clinically significant sleep disorder (see Appendix for questionnaire)
7. Is not already enrolled in the study with another patient participant (each carer participant can only take part once)

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 the 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 >3 weeks during intervention and follow-up (i.e approximately the next 4 months)

Study & Design

• Study Type: Interventional
• Study Design: Not specified