ISRCTN54051676进行中（未招募）Unknown
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 and sleep disturbance – a cluster randomised feasibility trial
niversity of Exeter0 个研究点目标入组 64 人开始时间: 2024年3月20日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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)
研究者
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