Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation
研究概览
详细说明
The purpose of this study is to perform a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people (N = 214) undergoing post-acute rehabilitation. The intervention will combine: 1) structured sleep assessment, 2) patient education in key elements of cognitive behavioral strategies to improve sleep, and 3) environmental interventions on factors which likely contribute to abnormal sleep/wake patterns in the post-acute rehabilitation setting.
This project will be conducted in a VA post-acute rehabilitation site. Older veterans (>= 60 years) who were previously community-dwelling (N = 214) will be randomized to receive the intervention, or a social contact and memory skills training program as the control condition. Data collected at baseline will include medical data and demographics, as well as subjective and objective measures of sleep, structured assessments of functional status, and medical comorbidity. Follow-up assessments will be performed in the facility while the intervention/control condition is in place, and at three months and six months after discharge from rehabilitation. The main outcome measures will include objective sleep measures (nighttime percent sleep and daytime percent sleep) and functional status collected at three and six months follow-up. Data will be analyzed for all randomized participants in an intention to treat analysis.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Sepulveda、California、美国、91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults aged > or = 60, who are admitted to inpatient rehabilitation services, who lived in a non-institutional setting prior to admission, and are admitted for rehabilitation
Exclusion Criteria:
- severe sleep apnea
- severe cognitive impairment
- not enrolled within one week of admission to rehabilitation unit
- too ill to participate
- and planned discharge to a nursing home for total nursing care
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Nonpharmacological sleep intervention
The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
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The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies
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有源比较器:Active control
Daily 15-minute social visit from a research assistant.
The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
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Daily 15-minute social visit from a research assistant.
The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Pittsburgh Sleep Quality Index
大体时间:3-month follow-up
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The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 - 21; score > 8 indicates poor sleep quality).
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3-month follow-up
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Sleep Efficiency
大体时间:3-month follow-up
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Average sleep efficiency calculated from 7 days of actigraphy.
Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed.
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3-month follow-up
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合作者和调查者
调查人员
- 首席研究员:Cathy A. Alessi, MD、VA Greater Los Angeles Healthcare System, Sepulveda, CA
出版物和有用的链接
一般刊物
- Martin JL, Jouldjian S, Mitchell MN, Josephson KR, Alessi CA. A longitudinal study of poor sleep after inpatient post-acute rehabilitation: the role of depression and pre-illness sleep quality. Am J Geriatr Psychiatry. 2012 Jun;20(6):477-84. doi: 10.1097/JGP.0b013e31824877c1.
- Skibitsky M, Edelen MO, Martin JL, Harker J, Alessi C, Saliba D. Can standardized sleep questionnaires be used to identify excessive daytime sleeping in older post-acute rehabilitation patients? J Am Med Dir Assoc. 2012 Feb;13(2):127-35. doi: 10.1016/j.jamda.2010.05.004. Epub 2010 Oct 2.
- Martin JL, Dzierzewski JM, Mitchell M, Fung CH, Jouldjian S, Alessi CA. Patterns of sleep quality during and after postacute rehabilitation in older adults: a latent class analysis approach. J Sleep Res. 2013 Dec;22(6):640-7. doi: 10.1111/jsr.12066. Epub 2013 Jul 8.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Nonpharmacological sleep intervention的临床试验
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Temple UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)完全的
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人