Early Phase 1 N=100 Randomized Prevention

SleepTrackTXT Feasibility and Pilot Study

Fatigue

Bottom Line

View on ClinicalTrials.gov: NCT02063737 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcome: Primary: Self-Reported Fatigue at End of Shift Work — 2.17; 1.78 units on a scale — p=0.0830

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Text-message assessments only (Behavioral); Text-message interventions for high level fatigue (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Self-Reported Fatigue at End of Shift Work	2.17; 1.78	0.0830
SECONDARY Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool	61.9; 69.3	0.0114 sig
SECONDARY Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool	27.8; 30.3	.99
SECONDARY Normative Beliefs Scale One Subscale of the SFAB	48.9; 59.7	0.0927
SECONDARY Normative Beliefs Scale Two Subscale of the SFAB	47.2; 58.8	0.0578
SECONDARY Self Efficacy Subscale of the SFAB	57.9; 58.9	0.69
SECONDARY Knowledge-one Subscale of SFAB	76.5; 81.4	0.65
SECONDARY Knowledge-two Subscale of the SFAB	77.1; 76.8	0.95
SECONDARY Importance Subscale of SFAB	62.0; 68.8	0.21
SECONDARY Environmental Constraints One Subscale of the SFAB	64.5; 64.4	0.51
SECONDARY Environmental Constraints Two Subscale of the SFAB	38.3; 45.5	0.28
SECONDARY Environmental Constraints Three Subscale of the SFAB	49.4; 44.5	0.0930
SECONDARY Habits Subscale of the SFAB	39.3; 48.5	0.56
SECONDARY Intentions Subscale of the SFAB	72.3; 77.4	0.20

Summary

Aim 1: To determine if real-time assessments of perceived sleepiness and fatigue using text-messaging impacts an emergency medicine clinician's Attitudes, Perceived Norms, Self-Efficacy, Alertness Habits, Perceived Importance of Fatigue, Knowledge of Sleepiness/Fatigue, and Perceptions of Environmental Constraints regarding behaviors that can improve alertness during shift work. Aim 2: To determine if text-messaging emergency care workers fatigue-reduction strategies in real-time at the start and during shift work reduces worker perceived sleepiness and fatigue at the end of shift work.

Eligibility Criteria

Inclusion Criteria

Are 18 years of age or older;
Currently work in the emergency medicine setting as an emergency physician, emergency nurse, or emergency medical technician (EMT) / paramedic worker;
Currently working shifts as part of your employment in the emergency medicine setting;
Have a cell-phone / smartphone that can receive and send text-messages;
Willing to take part in a research study where you are required to send and receive multiple text-messages at the start, during, and end of your shift work?

Exclusion Criteria

1: Those that do not meet inclusion criteria.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02063737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.