The SleepTrackTXT2 Randomized Trial With Air-medical Personnel (SleepTrack2)

December 24, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh Medical Center / STAT MedEvac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 4 hours up to 12 hours within work shifts
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.
Every 4 hours up to 12 hours within a work shift
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.
Every 4 hours up to 12 hours at end of work shift
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Daniel Patterson, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

December 26, 2019

Last Update Submitted That Met QC Criteria

December 24, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO16030345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Do not plan to share data unless required by the MedEvac Foundation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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