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临床试验/NCT04456764
NCT04456764终止不适用

Real-time Intervention to Reduce Fatigue Among Emergency Medical Services Workers: A Cluster-randomized Trial

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 708 人开始时间: 2020年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
708
试验地点
2
主要终点
Fatigue

研究概览

简要总结

More than half of Emergency Medical Services (EMS) workers report work-related mental and physical fatigue. Odds of injury among fatigued EMS workers are nearly double that of non-fatigued workers. There is a compelling need to reduce fatigue among EMS workers, yet few EMS organizations have a formal fatigue management program and many may not be cost-effective or evidence-based. This trial addresses national goals of the National Occupational Research Agenda (NORA) and tests a novel approach to fatigue risk management that is easily scalable to large workforces and low-cost for employers of shift workers.

详细描述

The investigators will test an enhanced version of our SleepTrackTXT pilot intervention - Sleep and Fatigue Treatment in EMS (SaFTiE) - in a two-arm parallel cluster-randomized design of EMS agencies. Our unit of randomization will be the EMS agency, with the intervention deployed as a Fatigue Risk Management Program that can be integrated into an agency's existing program. During the active intervention phase, the investigators will use SaFTiE and an attention placebo control (APC) group to test the specific effect of our multi-component intervention on EMS worker fatigue and sleep health.

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
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

入选标准

  • 18 years or older
  • Live in United States (including Hawaii and Alaska)
  • Licensed / certified EMS clinician
  • Currently work in shifts
  • Do at least one clinical shift per week
  • Own a smartphone
  • Willing to answer monthly surveys and daily text-messages,

排除标准

  • Exclude EMS personnel who are primarily administrative with non-clinical duties
  • Are restricted from using personal smartphone during periods of work
  • Do not own a smartphone capable of running the study mobile app

结局指标

主要结局

Fatigue

时间窗: At baseline, 3 months, and 6 months

A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) \[minimum score=0, maximum score=11, and scores \>=4 indicate mental and physical fatigue\]

次要结局

  • Pittsburgh Sleep Quality Index (PSQI)(Baseline, 3 months, and 6 months)
  • Poor Sleep Quality(At 6 months)
  • Inter-Shift Recovery Measure(At baseline, 3 months, and 6 months)
  • Acute Fatigue Measure(Baseline, 3 months, and 6 months)
  • Chronic Fatigue Measure(Baseline, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Patterson, PhD, NRP

Associate Professor

University of Pittsburgh

研究点 (2)

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