NCT01646723已完成不适用
Volunteers Adding Life in Dementia (VALID)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Cohen-Mansfield Agitation Inventory (CMAI) score
研究概览
简要总结
The objectives of our project are to: 1.) Develop a training program and manual for volunteers to implement evidence-based, non-pharmacological interventions for neuropsychiatric symptoms (NPS) of dementia in long-term care (LTC) settings; 2.) Recruit and train volunteers using the VALID program and pilot test the volunteer-led program with 20 individuals with Alzheimer's disease and NPS in a LTC facility in Kingston; and, 3.) Evaluate the effects of the VALID program on the symptoms of NPS, patient quality of life, volunteer's experience, and LTC staff stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Alzheimer's disease or related forms of dementia
- •significant symptoms of agitation as measured by a Cohen-Mansfield Agitation Inventory (CMAI) total score of >39
- •in nursing home for at least 30 days
- •presence of a caregiver or substitute decision maker willing to consent to treatment
- •no changes in psychotropic medications in the 2 weeks preceding enrolment in study
排除标准
- •depressive symptoms presenting risk
- •physically aggressive behavior posing safety risk to others
- •uncontrolled pain
- •currently receiving palliative care
- •medically unstable with life expectancy of < 6 months
- •currently awaiting transfer to another LTC facility or hospital.
结局指标
主要结局
Change in Cohen-Mansfield Agitation Inventory (CMAI) score
时间窗: Baseline and 12 weeks
次要结局
- Clinically significant reduction in agitation(Baseline and 12 weeks)
- Change in depression symptoms (Cornell Depression in Dementia Rating Scale)(Baseline and 12 weeks)
- Change in Modified Nursing Care Assessment Scale score(Baseline and 12 weeks)
- Clinical Global Impression of Change (CGI-C)(Baseline and 12 weeks)
- Remission of neuropsychiatric symptoms(Baseline and 12 weeks)
- Change in Neuropsychiatric Inventory (NPI) score(Baseline and 12 weeks)
- Use and dose of required medication(Baseline and 12 weeks)
- Dementia Quality of Life (DemQoL) Scale(Baseline and 12 weeks)
- Short form health survey(Baseline and 12 weeks)
研究者
研究点 (2)
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