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临床试验/NCT04151251
NCT04151251已完成不适用

Mentoring Patient-Oriented Research: Sleep & Health During & After Hospital Stay

University of Chicago2 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2020年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
256
试验地点
2
主要终点
Karolinska Sleep Log - Sleep Times

研究概览

简要总结

While many interventions have targeted hospital staff to improve sleep, few have been successful, and often suffer from limited adherence to staff protocols. Given preliminary data that suggests that empowered patients are more likely to obtain better sleep and have objectively lower noise levels in their rooms, it is plausible that partnering directly with patients can mitigate sleep loss and improve health outcomes. Patients will be randomized to receive the I-SLEEP education and empowerment program and test the effectiveness of this program on patient sleep and health outcome in the hospital and post-discharge. The aim of the project is to reduce environmental, healthcare-related, and patient-related factors that disrupt sleep of hospitalized patients by use of patient education and empowerment intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Trained research assistants will introduce the interventions to patients, leaving the outcomes assessor and investigator only able to see results. The care provider is not part of the study decision, as the study does not affect their healthcare.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to the general/hospitalist medicine departments
  • Stayed at least one night in hospital since admission

排除标准

  • Admitted >72 hours ago
  • Patient has been diagnosed with a sleep disorder such as narcolepsy, insomnia, or sleep apnea
  • Patient was transferred from ICU or outside hospital
  • Patient under strict, droplet, or airborne isolation precautions
  • Unable to ambulate
  • Too confused or incoherent to provide consent
  • Patient cannot speak English
  • Pregnancy
  • Residence in a nursing home or assisted living facility
  • Patient was admitted in a hospital within two weeks of current admission

结局指标

主要结局

Karolinska Sleep Log - Sleep Times

时间窗: Through stay in the hospital until discharge, usually 2-3 days

A self-reported measure of time spent sleeping, time it took to fall asleep, etc.

次要结局

  • Karolinska Sleep Log - Outcomes of Sleep(Through stay in the hospital until discharge, usually 2-3 days)
  • Actigraphy - Objective Measure of Sleep Duration(During stay at the hospital, for a week after, and for a week three months after discharge)
  • Actigraphy - Objective Measure of Sleep Quality(During stay at the hospital, for a week after, and for a week three months after discharge)
  • Frequency of Sleep Disruptions in the Hospital Setting(Through stay in the hospital until discharge, usually 2-3 days)
  • Number of nighttime disruptions to sleep(Through stay in the hospital until discharge, usually 2-3 days)
  • Patients Who Report Talking to Clinicians About Their Healthcare(Through stay in the hospital until discharge, usually 2-3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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