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The SleepTrackTXT2 Randomized Trial With Air-medical Personnel

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02783027
Acronym
SleepTrack2
Enrollment
83
Registered
2016-05-26
Start date
2016-06-30
Completion date
2017-10-31
Last updated
2019-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Poor Quality Sleep

Brief 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.

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.

Interventions

BEHAVIORALSleepTrackTXT2

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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep Quality4 monthsMeasured 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

MeasureTime frameDescription
Fatigue During ShiftworkEvery 4 hours up to 12 hours within work shiftsSingle 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.
Sleepiness During ShiftworkEvery 4 hours up to 12 hours within a work shiftSingle 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.
Difficulty With Concentration During ShiftworkEvery 4 hours up to 12 hours at end of work shiftSingle 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.
Inter-Shift Recovery4 monthsThe Occupational Fatigue Exhaustion Recovery Scale Inter-shift Recovery Subscale. Scores range from 0 to 100. Scores 50-100 imply moderate to high recovery.

Countries

United States

Participant flow

Participants by arm

ArmCount
SleepTrackTXT2
Participants receive text-message 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.
39
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.
44
Total83

Baseline characteristics

CharacteristicText-Message Assessments OnlyTotalSleepTrackTXT2
Age, Continuous41.8 years
STANDARD_DEVIATION 9.8
41.4 years
STANDARD_DEVIATION 9.7
40.9 years
STANDARD_DEVIATION 9.5
Most Common Shift Length
12 Hours
22 Participants40 Participants18 Participants
Most Common Shift Length
24 Hours
21 Participants39 Participants18 Participants
Most Common Shift Length
Other
0 Participants2 Participants2 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
15 Participants34 Participants19 Participants
Sex: Female, Male
Male
27 Participants46 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 44
other
Total, other adverse events
0 / 390 / 44
serious
Total, serious adverse events
0 / 390 / 44

Outcome results

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.

Time frame: 4 months

Population: Individuals with outcome measured at 4 months.

ArmMeasureValue (MEAN)Dispersion
SleepTrackTXT2Sleep Quality7.9 score on a scaleStandard Deviation 3.6
Text-Message Assessments OnlySleep Quality6.5 score on a scaleStandard Deviation 4
p-value: 0.76t-test, 2 sided
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.

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

Population: Number with shift data at 30 days

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
SleepTrackTXT2Difficulty With Concentration During ShiftworkStart of shift0.52 score on a scale
SleepTrackTXT2Difficulty With Concentration During Shiftwork4 hours0.68 score on a scale
SleepTrackTXT2Difficulty With Concentration During Shiftwork8 hours1.12 score on a scale
SleepTrackTXT2Difficulty With Concentration During Shiftwork12 hours end of shift1.12 score on a scale
Text-Message Assessments OnlyDifficulty With Concentration During Shiftwork12 hours end of shift1.76 score on a scale
Text-Message Assessments OnlyDifficulty With Concentration During ShiftworkStart of shift0.46 score on a scale
Text-Message Assessments OnlyDifficulty With Concentration During Shiftwork8 hours1.27 score on a scale
Text-Message Assessments OnlyDifficulty With Concentration During Shiftwork4 hours0.71 score on a scale
p-value: <0.0001Mixed Models Analysis
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.

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

Population: Participants with at least some intra-shift data on fatigue.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
SleepTrackTXT2Fatigue During ShiftworkStart of Shift0.71 score on a scale
SleepTrackTXT2Fatigue During Shiftwork4 hours0.96 score on a scale
SleepTrackTXT2Fatigue During Shiftwork8 hours1.45 score on a scale
SleepTrackTXT2Fatigue During Shiftwork12 hours (end of shift)1.5 score on a scale
Text-Message Assessments OnlyFatigue During Shiftwork12 hours (end of shift)2.19 score on a scale
Text-Message Assessments OnlyFatigue During ShiftworkStart of Shift0.79 score on a scale
Text-Message Assessments OnlyFatigue During Shiftwork8 hours1.79 score on a scale
Text-Message Assessments OnlyFatigue During Shiftwork4 hours1.10 score on a scale
p-value: <0.0001Mixed Models Analysis
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.

Time frame: 4 months

Population: Participants with survey data at 4 months.

ArmMeasureValue (MEAN)Dispersion
SleepTrackTXT2Inter-Shift Recovery51.7 score on a scaleStandard Deviation 20
Text-Message Assessments OnlyInter-Shift Recovery56.3 score on a scaleStandard Deviation 18.8
p-value: 0.91t-test, 2 sided
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.

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

Population: Individuals with shift data up to 30 days

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
SleepTrackTXT2Sleepiness During ShiftworkStart of shift0.84 score on a scale
SleepTrackTXT2Sleepiness During Shiftwork4 hours1.01 score on a scale
SleepTrackTXT2Sleepiness During Shiftwork8 hours1.48 score on a scale
SleepTrackTXT2Sleepiness During Shiftwork12 hours at shift end1.62 score on a scale
Text-Message Assessments OnlySleepiness During Shiftwork12 hours at shift end2.50 score on a scale
Text-Message Assessments OnlySleepiness During ShiftworkStart of shift0.82 score on a scale
Text-Message Assessments OnlySleepiness During Shiftwork8 hours2.01 score on a scale
Text-Message Assessments OnlySleepiness During Shiftwork4 hours1.29 score on a scale
p-value: <0.0001Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026