Trial Outcomes & Findings for SleepTrackTXT Feasibility and Pilot Study (NCT NCT02063737)

NCT ID: NCT02063737

Last Updated: 2015-08-05

Results Overview

Self-reported fatigue based on scale ranging from 0 (Not At All) to 5 (Very Much).

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 100 participants
• Primary outcome timeframe: At the end of scheduled work shifts during a 90 day study period
• Results posted on: 2015-08-05

Participant Flow

Participant milestones

Measure	Control Group The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Overall Study STARTED	52	48
Overall Study COMPLETED	41	44
Overall Study NOT COMPLETED	11	4

Reasons for withdrawal

Measure	Control Group The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Overall Study Lost to Follow-up	11	4

Baseline Characteristics

SleepTrackTXT Feasibility and Pilot Study

Baseline characteristics by cohort

Measure	Control Group n=52 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=48 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.	Total n=100 Participants Total of all reporting groups
Age, Continuous	36.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	35.0 years STANDARD_DEVIATION 9.7 • n=7 Participants	35.6 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	18 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	30 Participants n=7 Participants	71 Participants n=5 Participants
Certification/License EMT-Basic	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Certification/License Paramedic	34 participants n=5 Participants	31 participants n=7 Participants	65 participants n=5 Participants
Certification/License Nurse	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants
Certification/License Physician/Other	7 participants n=5 Participants	2 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of scheduled work shifts during a 90 day study period

Population: Analysis using intention to treat.

Self-reported fatigue based on scale ranging from 0 (Not At All) to 5 (Very Much).

Outcome measures

Measure	Control Group n=1389 Shifts The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=1232 Shifts The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Self-Reported Fatigue at End of Shift Work	2.17 units on a scale Standard Error 0.1746	1.78 units on a scale Standard Error 0.1782

SECONDARY outcome

Timeframe: Assessed at the end of 90-day study period

Population: Intention to treat among participants with 90 day data (completers)

Individual attitudes towards maintaining alertness and reducing fatigue at work. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool	61.9 units on a scale Standard Deviation 19.9	69.3 units on a scale Standard Deviation 17.1

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Individual attitudes towards maintaining alertness and reducing fatigue at work on future shifts. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool	27.8 units on a scale Standard Deviation 21.1	30.3 units on a scale Standard Deviation 22.8

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Belief of people's views if they thought you were sleepy and fighting the urge to sleep while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Normative Beliefs Scale One Subscale of the SFAB	48.9 units on a scale Standard Deviation 18.8	59.7 units on a scale Standard Deviation 18.8

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Belief of people's views if they thought you were very fatigued mentally or physically while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Normative Beliefs Scale Two Subscale of the SFAB	47.2 units on a scale Standard Deviation 19.8	58.8 units on a scale Standard Deviation 25.6

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Degree of confidence from 0 (cannot do at all) to 100 (highly certain can do) for completing activities. Higher scores indicate the individual has a high-level of self-confidence he/she can perform select behaviors that may improve alertness and reduce feelings of sleepiness or fatigue while at work.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Self Efficacy Subscale of the SFAB	57.9 units on a scale Standard Deviation 24.9	58.9 units on a scale Standard Deviation 26.8

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Perception that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Knowledge-one Subscale of SFAB	76.5 units on a scale Standard Deviation 22.5	81.4 units on a scale Standard Deviation 19.5

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Perceived degree of evidence that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Knowledge-two Subscale of the SFAB	77.1 units on a scale Standard Deviation 17.8	76.8 units on a scale Standard Deviation 18.3

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Level of importance an individual places on the need to maintain alertness and reduce feelings of fatigue and/or sleepiness while at work ranging from 0 (strongly disagree) to 100 (strongly agree). Strongly agree (higher score) is associated with high level of importance (endorsement) placed on the need to maintain alertness and reduce feelings of fatigue while at work.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Importance Subscale of SFAB	62.0 units on a scale Standard Deviation 16.5	68.8 units on a scale Standard Deviation 18.6

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Degree of importance of employer based barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer's policies and organizational related procedures/protocols as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Environmental Constraints One Subscale of the SFAB	64.5 units on a scale Standard Deviation 27.5	64.4 units on a scale Standard Deviation 29.6

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Degree of importance of employer policies that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer's policies and organizational related procedures/protocols as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Environmental Constraints Two Subscale of the SFAB	38.3 units on a scale Standard Deviation 31.1	45.5 units on a scale Standard Deviation 33.4

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Degree of importance of personal/work-life barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her responsibilities unrelated to the organization as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Environmental Constraints Three Subscale of the SFAB	49.4 units on a scale Standard Deviation 24.4	44.5 units on a scale Standard Deviation 23.0

SECONDARY outcome

Timeframe: end of study at the 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

Endorsement of behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work ranging from 0 (strongly agree) to 100 (strongly disagree). Strongly agree (lower score) is associated with high level of endorsement of behaviors (habits) that promote improved alertness.

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Habits Subscale of the SFAB	39.3 units on a scale Standard Deviation 21.6	48.5 units on a scale Standard Deviation 26.8

SECONDARY outcome

Timeframe: end of study at 90 day follow up

Population: Intention to treat among participants with 90 day data (completers)

An individual's intent to engage in behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work with higher scores indicating greater intent. Range is 0 (strongly agree) to 100 (strongly disagree).

Outcome measures

Measure	Control Group n=41 Participants The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.	Intervention Group n=44 Participants The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue. Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness.
Intentions Subscale of the SFAB	72.3 units on a scale Standard Deviation 14.7	77.4 units on a scale Standard Deviation 17.0

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Patterson

Carolinas HealthCare System

Phone: 704-446-0433

Email: Daniel.Patterson@carolinas.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place