The SleepTrackTXT2 Randomized Trial With Air-medical Personnel

Fatigue Clinical Trial

— SleepTrack2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783027
• Other study ID #: PRO16030345
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 2017

Study information

• Verified date: December 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Poor Quality Sleep

Intervention

Behavioral:
• SleepTrackTXT2
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center / STAT MedEvac	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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 Rand — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality	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.	4 months
Secondary	Fatigue During Shiftwork	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.	Every 4 hours up to 12 hours within work shifts
Secondary	Sleepiness During Shiftwork	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.	Every 4 hours up to 12 hours within a work shift
Secondary	Difficulty With Concentration During Shiftwork	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.	Every 4 hours up to 12 hours at end of work shift
Secondary	Inter-Shift Recovery	The Occupational Fatigue Exhaustion Recovery Scale Inter-shift Recovery Subscale. Scores range from 0 to 100. Scores 50-100 imply moderate to high recovery.	4 months