Environmental Design for Behavioral Regulation in People With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Success Rate of Adherence
研究概览
简要总结
Individuals with dementia present with changes in behaviors throughout the continuum of cognitive decline. Environmental features may be influential in behavioral regulation. The purpose of this study is to assess the feasibility of environmental design protocols in older adults with dementia and their caregivers. Thirty subjects with moderate to severe Alzheimer's disease as primary dementia type, and their caregivers, will be randomly assigned to one of three arms: standard care; standard environmental design protocol; or personalized environmental design protocol.
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
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women aged 21-90, inclusive.
- •Living at home in the community with one primary caregiver.
- •Diagnosis of Alzheimer's disease as primary dementia type of moderate to severe stages
- •Stable medical condition for one month prior to screening visit
- •Stable medications for 4 weeks prior to screening visit
- •Caregiver report of challenges related to behaviors within 4 weeks of study enrollment
- •Caregiver willing to participant throughout duration of study
排除标准
- •Unstable medical conditions for 3 months prior to screening
- •Wheelchair or bed bound.
- •Residence in skilled nursing facility or facility-based care.
- •Skin lesions or skin abnormalities throughout upper extremities.
结局指标
主要结局
Success Rate of Adherence
时间窗: 6 weeks
Percentage of participants who had 75% adherence to the protocol based on visits and journals.
次要结局
- Change in Behavior(10 weeks (at baseline, 6 weeks and the 4 week follow up))
- Change in Occupational Performance(10 weeks (at baseline, 6 weeks and the 4 week follow up))
研究者
Elizabeth K Rhodus
Assistant Professor
University of Kentucky