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NCT Number: NCT02783027

The SleepTrackTXT2 Randomized Trial With Air-medical Personnel

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.

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Key information

Conditions

Poor Quality Sleep Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center / STAT MedEvac

Pittsburgh, Pennsylvania, 15261, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SleepTrackTXT2

Behavioral

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.

Primary outcomes

  1. Sleep Quality

    Time frame: 4 months

    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.

Secondary outcomes

  1. Fatigue During Shiftwork

    Time frame: Every 4 hours up to 12 hours within work shifts

    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.

  2. Sleepiness During Shiftwork

    Time frame: Every 4 hours up to 12 hours within a work shift

    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.

  3. Difficulty With Concentration During Shiftwork

    Time frame: Every 4 hours up to 12 hours at end of work shift

    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.

  4. Inter-Shift Recovery

    Time frame: 4 months

    The Occupational Fatigue Exhaustion Recovery Scale Inter-shift Recovery Subscale. Scores range from 0 to 100. Scores 50-100 imply moderate to high recovery.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Real-time Fatigue Mitigation With Air-medical Personnel: The SleepTrackTXT2 Randomized Trial

Acronym: SleepTrack2

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 26, 2016
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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