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临床试验/NCT03327324
NCT03327324
已完成
不适用

Improving Sleep Using Mentored Behavioral and Environmental Restructuring

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 110 人2018年3月27日
适应症Insomnia

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Insomnia
发起方
NYU Langone Health
入组人数
110
试验地点
1
主要终点
Daytime Sleeping (Napping) Time
状态
已完成
最后更新
3年前

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.

注册库
clinicaltrials.gov
开始日期
2018年3月27日
结束日期
2021年2月23日
最后更新
3年前
研究类型
Interventional
研究设计
Sequential
性别
All

研究者

责任方
Sponsor

入排标准

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.

研究点 (1)

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