Reducing Hypnotic Drug Use and Improving Night-time Care for People Living With Dementia in Care Homes (NightCAP): A Randomised Factorial Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- Sleep Disturbance Inventory SDI
研究概览
简要总结
Dementia is a devastating condition characterised by progressive loss of cognition leading to loss of independence and eventually death. One major unmet need, which remains a critical challenge for care provision, is the management of night-time care and sleep-related symptoms in people with dementia living in care homes. The causes and impacts of sleep disturbances in people with dementia in care homes are complex and multi-faceted, indicating the need of a whole-systems approach to the issue. It will require a tailored, person-centred approach which accounts for the environmental, personal and clinical factors contributing to the symptoms.
The aim of this study is to evaluate the NightCAP intervention to improve treatment of sleep disturbance in people with dementia in care homes, with the goal of reducing sleep disturbance behaviour and reducing the use of hypnotic drugs. This will provide robust evidence to support guidance on night time care and improving hypnotic drug prescribing, both of which are major unmet needs in the care of people with dementia.
详细描述
The main objective of this current study is to explore the effectiveness of specific benefits of key components of the Night Time Care Activities Programme- NightCAP. Particularly elements of sleep hygiene and personalised night-time care planning. There may also be additional benefit in combining NightCAP elements with pharmacological review protocol to enable management of all major contributing factors in sleep disturbance.
This cluster-randomised trial will be delivered in 24 UK care homes. Participants will be individuals living with dementia and experiencing sleep disturbance, as well as staff who care for them. Homes will be randomly allocated to one of two arms: optimised usual care or the intervention arm. All homes will receive an optimised person-centred care module. The NightCAP intervention programme consists of three key elements: (i) personalised night-time care planning (supported staff training and implementation); (ii) structured sleep hygiene (staff training); and (iii) hypnotic drug review protocol (GP fact sheet and staff training). The primary outcome will be sleep disturbance at the end of the intervention. Secondary outcomes will be hypnotic drug use, quality of life, resident falls, job satisfaction, burden and coping in care staff, and cost effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Care homes (inclusive of residential and nursing) that have failed to meet more than 1 of the 5 CQC care home quality standards check
- •Care homes who have at least 12 eligible care home resident participants
- •Care homes with a minimum of two residents who are eligible to participate in the study taking hypnotic medication
- •Resident participants will have an established or probable diagnosis of dementia
- •Residents will have experienced an episode/occurrence of sleep disturbance behaviour in the past four weeks/two weeks (as reported by care staff)
- •Care home member of staff whose duties include providing care to individuals with dementia
- •Care home care staff are required to have an adequate level of English language to complete all required assessment outcomes
- •Care home care staff participants who will remain in work without plans for extended leave over the study period
排除标准
- •Care homes receiving special support from the local authority
- •Agency care staff
- •Care staff will be able to withdraw from the study at any time
结局指标
主要结局
Sleep Disturbance Inventory SDI
时间窗: From baseline and immediately after intervention
Sleep disturbance behaviour as measured by the Sleep Disturbance Inventory SDI
次要结局
- Global Deterioration Scale (GDS)(From baseline, immediately after intervention and at four months follow-up)
- Neuropsychiatric Inventory- Nursing Home (NPI-NH)(From baseline, immediately after intervention and at four months follow-up)
- Cohen-Mansfield Agitation Inventory (CMAI)(From baseline, immediately after intervention and at four months follow-up)
- EQ5D-5L(From baseline, immediately after intervention and at four months follow-up)
- Abbey Pain Scale(From baseline, immediately after intervention and at four months follow-up)
- Approached to Dementia Questionnaire (ADQ)(From baseline, immediately after intervention and at four months follow-up)
- Change of Hypnotic Drug Use(From baseline, immediately after intervention and at four months follow-up)
- Patient Health Questionnaire 9 (PHQ-9)(From baseline, immediately after intervention and at four months follow-up)
- Dementia Quality of Life(From baseline, immediately after intervention and at four months follow-up)
- Client Service Receipt Inventory (CSRI)(From baseline, immediately after intervention and at four months follow-up)
- Functional Assessment Staging (FAST)(From baseline, immediately after intervention and at four months follow-up)