TIME - Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 2
- 主要终点
- NPI-NH agitation/aggression
研究概览
简要总结
Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT). The TIME trial is designed to assess the effects of TIME on NPS in nursing homes patients with dementia and the implementation process at staff and organization level.
详细描述
TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT).The TIME trial includes a three months cluster randomized trial in 36 nursing homes with 164 participants with dementia and a high level of agitation. Each nursing home defines a cluster and will be randomized to receive either the intervention with TIME or a brief two hours education-only intervention about dementia and NPS for the control group. TIME consists of a manual based multicomponent program which includes a rigorous assessment, the treatment, and the evaluation of neuropsychiatrc symptoms (NPS). The staff, physicians and nursing home managers receive a one-day education. Three nurses from each unit will receive further education including practical and theoretical training for three hours. Measurements at patient level are taken at baseline prior to randomization and at eight and twelve weeks. The primary outcome measure is agitation. Mixed methods will be used to follow, measure and explore the implementation process and the effect at individual staff level and at organization level.
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
- •Clinical Dementia Rating scale (CDR) 1 or higher.
- •Moderate to high grade of agitation defined by the NPI-NH agitation item as equal to or above six points.
- •Planned long-term stay in the nursing home, and a minimum of two weeks stay in the nursing home before inclusion.
排除标准
- •1.Terminal phase (life expectancy less than 4-6 weeks)
结局指标
主要结局
NPI-NH agitation/aggression
时间窗: 8 weeks and 12 weeks
The primary outcome measure is change from baseline of agitation and aggression as defined by the Neuropsychiatric Inventory Nursing Home Version (NPI-NH) item agitation/aggression.
次要结局
- The NPI-NH caregiver occupational disruptiveness score(8 weeks and 12 weeks)
- CMAI(8 weeks and 12 weeks)
- NPI-NH sub syndrome psychosis(8 weeks and 12 weeks)
- Lawton and Brody ADL scale(8 weeks and 12 weeks)
- Quality of life measured by the scale QUALID(8 weeks and 12 weeks)
- General medical health using the General Medical Health Rating scale(8 weeks and 12 weeks)
- NPI-NH all separate items(8 weeks and 12 weeks)
- NPI-NH sub syndrome agitation(8 weeks and 12 weeks)
- NPI-NH sub syndrome affective symptoms(8 weeks and 12 weeks)
- NPI-10 NH sum score(8 weeks and 12 weeks)
- The Cornell scale for depression in dementia CSDD(8 weeks and 12 weeks)
- Drug usage(8 weeks and 12 weeks)