The SleepTrackTXT2 Randomized Trial With Air-medical Personnel (SleepTrack2)
2019年12月24日 更新者：Daniel Patterson, PhD, NRP、University of Pittsburgh
Real-time Fatigue Mitigation With Air-medical Personnel: The SleepTrackTXT2 Randomized Trial
The overarching goal of this proposal is to address the MedEvac foundation priority of educational techniques and technologies and improve Helicopter Emergency Medical Services (HEMS) safety by determining if overall sleep quality and intra-shift fatigue of HEMS clinicians can be improved with real-time assessment and intervention.
Aim 1: To determine the short-term impact of an enhanced SleepTrackTXT intervention on HEMS clinician fatigue reported in real-time during and at the end of shift work.
Aim 2: To determine the long-term impact of the SleepTrackTXT intervention on sleep quality and sleep health indicators including hours of sleep and recovery between shift work.
研究概览
详细说明
The investigators will examine short term impact by examining self-reported fatigue captured at the start, during, and end of scheduled shifts.
The investigators will determine longer-term impact on sleep quality by comparing scores on the Pittsburgh Sleep Quality Index (PSQI) taken at baseline and then again at 4 months.
研究类型
介入性
注册 (实际的)
83
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15261
- University of Pittsburgh Medical Center / STAT MedEvac
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 years of age and older
- working clinically at a study site
- currently working in shifts
- has a smart phone and
- willing to take part in a research study that requires the sending and receiving of multiple text messages daily over 4-months
Exclusion Criteria:
- does not meet inclusion criteria
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：SleepTrackTXT2
Participants will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift).
Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness.
Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt.
Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
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Participants that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness during shift work.
Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt.
Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
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无干预：Text-Message Assessments Only
Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift).
The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration.
No intervention messages sent to this group/arm.
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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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Sleep Quality
大体时间：4 months
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Measured by the Pittsburgh Sleep Quality Index (PSQI); Scores range from 0 to 21.
Higher scores indicate poorer sleep quality.
Scores >6 indicate poor sleep quality.
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4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fatigue During Shiftwork
大体时间：Every 4 hours up to 12 hours within work shifts
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Single item measure of fatigue taken at beginning, every 4-hours, and at the end of shifts.
Scores range from 0 (Not at all) to 5 (Very much); higher scores indicate more fatigue.
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Every 4 hours up to 12 hours within work shifts
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Sleepiness During Shiftwork
大体时间：Every 4 hours up to 12 hours within a work shift
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Single item measure of sleepiness taken at beginning, every 4-hours, and at the end of shifts.
Scores range from 0 (Not at all) to 5 (Very much).
Higher scores indicate more sleepiness.
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Every 4 hours up to 12 hours within a work shift
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Difficulty With Concentration During Shiftwork
大体时间：Every 4 hours up to 12 hours at end of work shift
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Single item measure of difficulty with concentration taken at beginning, every 4-hours, and at the end of shifts.
Scores range from 0 (Not at all) to 5 (Very much).
Higher scores indicate more difficulty with concentration.
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Every 4 hours up to 12 hours at end of work shift
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Inter-Shift Recovery
大体时间：4 months
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The Occupational Fatigue Exhaustion Recovery Scale Inter-shift Recovery Subscale.
Scores range from 0 to 100.
Scores 50-100 imply moderate to high recovery.
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4 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Daniel Patterson, PhD、University of Pittsburgh
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Patterson PD, Moore CG, Guyette FX, Doman JM, Sequeira D, Werman HA, Swanson D, Hostler D, Lynch J, Russo L, Hines L, Swecker K, Runyon MS, Buysse DJ. Fatigue mitigation with SleepTrackTXT2 in air medical emergency care systems: study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):254. doi: 10.1186/s13063-017-1999-z.
- Patterson PD, Moore CG, Guyette FX, Doman JM, Weaver MD, Sequeira DJ, Werman HA, Swanson D, Hostler D, Lynch J, Russo L, Hines L, Swecker K, Kroemer AJ, Runyon MS, Buysse DJ. Real-Time Fatigue Mitigation with Air-Medical Personnel: The SleepTrackTXT2 Randomized Trial. Prehosp Emerg Care. 2019 Jul-Aug;23(4):465-478. doi: 10.1080/10903127.2018.1532476. Epub 2018 Oct 29.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年6月1日
初级完成 (实际的)
2017年8月1日
研究完成 (实际的)
2017年10月1日
研究注册日期
首次提交
2016年5月23日
首先提交符合 QC 标准的
2016年5月25日
首次发布 (估计)
2016年5月26日
研究记录更新
最后更新发布 (实际的)
2019年12月26日
上次提交的符合 QC 标准的更新
2019年12月24日
最后验证
2019年12月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PRO16030345
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Do not plan to share data unless required by the MedEvac Foundation
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.