Improving Sleep Using Mentored Behavioral and Environmental Restructuring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Daytime Sleeping (Napping) Time
研究概览
简要总结
The goal of this study is to test potential functional/psychosocial benefits of improved sleep using a program designed to teach nursing facility staff to improve sleep promoting strategies and environment for nursing home residents. Sleep disturbances are quite common in skilled nursing facilities and affect as many as 69% of residents while staff do not fully understand how to improve sleep without using medications. Medications for sleep are commonly used as first-line therapy for older adults but this is problematic because these medications can lead to greater problems with thinking, more frequent falls, and even worse sleep over time. In addition, poor sleep can lead to depressed mood, greater trouble with thinking and memory, worse pain, and greater need for help with daily activities.
详细描述
This is a study to test the effects of improved sleep quality on downstream functional/psychosocial outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •living in the unit of intervention,
- •ability to communicate and follow simple commands,
- •English- or Spanish-speaking,
- •capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.
排除标准
- •Does not have capacity and does not show enthusiasm for the research
- •Does not have capacity and does not have a proxy.
- •obtunded or comatose state,
- •inability to communicate verbally,
- •inability to consent and without surrogate
- •non-English and non-Spanish speaking. In keeping with QI strategies, all residents will be exposed to the environmental aspects of the intervention, as these strategies represent clinically proven non-experimental behavioral strategies with no perceptible harm.
结局指标
主要结局
Daytime Sleeping (Napping) Time
时间窗: Month 9 Post-Baseline
Wrist device / actigraphy will be used to measure sleep/wake time.
Score on Pittsburgh Sleep Quality Index (PSQI)
时间窗: Month 9 Post-Baseline
PSQI contains 19 self-rated questions. The 19 questions are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The total score range is 0-21; the higher the score, the greater the difficulties in all areas.
Nighttime Total Awake Time
时间窗: Month 9 Post-Baseline
Data will be obtained from antigraphy analysis.
Brief Anxiety and Depression Scale (BADS) Questionnaire Score
时间窗: Month 9 Post-Baseline
BADS is a brief screening tool for mood impairment developed for older adults. It consists of 8 questions, answered 0 (no), 1(somewhat), or 2 (yes). The total score range is 0-16; the higher the score, the higher the level of mood impairment
Score on Brief Cognitive Assessment Tool (BCAT)
时间窗: Month 9 Post-Baseline
BCAT is a multi-domain cognitive instrument that assesses orientation, verbal recall, visual recognition, visual recall, attention, abstraction, language, executive functions, and visuo-spatial processing in adult and older adult populations. It consists of 21 items. The total score range is 0-50; the higher the score, the more normal the level of cognitive functioning and independent living.
Sleep Efficiency (SE)
时间窗: Month 9 Post-Baseline
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
次要结局
未报告次要终点