Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

SleepTrackTXT Feasibility and Pilot Study (SleepTrackTXT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02063737
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : July 13, 2015
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
Daniel Patterson, PhD, NREMT-P, University of Pittsburgh

Brief 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.


Condition or disease Intervention/treatment Phase
Fatigue Behavioral: Text-message assessments only Behavioral: Text-message interventions for high level fatigue Early Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Sleep Track Text Pilot Trial in Emergency Care Clinicians
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Sham Comparator: Control Group
The control group will receive text-message assessments only 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.
Behavioral: Text-message assessments only
Text message assessments only. No intervention for high level fatigue.

Experimental: Intervention Group
The intervention group will receive the same text-message assessments as the control group. In addition, these subjects will receive text-message interventions for high level fatigue 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.
Behavioral: Text-message interventions for high level fatigue
Intervention messages to promote alertness while on duty at work including activities. Additionally at the end of the shift, participants were queried on their adoption of the suggested activities and perception of the activities' effectiveness.




Primary Outcome Measures :
  1. Self-Reported Fatigue at End of Shift Work [ Time Frame: At the end of scheduled work shifts during a 90 day study period ]
    Self-reported fatigue based on scale ranging from 0 (Not At All) to 5 (Very Much).


Secondary Outcome Measures :
  1. Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool [ Time Frame: Assessed at the end of 90-day study period ]
    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.

  2. Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool [ Time Frame: end of study at 90 day follow up ]
    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.

  3. Normative Beliefs Scale One Subscale of the SFAB [ Time Frame: end of study at 90 day follow up ]
    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.

  4. Normative Beliefs Scale Two Subscale of the SFAB [ Time Frame: end of study at 90 day follow up ]
    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.

  5. Self Efficacy Subscale of the SFAB [ Time Frame: end of study at 90 day follow up ]
    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.

  6. Knowledge-one Subscale of SFAB [ Time Frame: end of study at 90 day follow up ]
    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.

  7. Knowledge-two Subscale of the SFAB [ Time Frame: end of study at 90 day follow up ]
    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.

  8. Importance Subscale of SFAB [ Time Frame: end of study at 90 day follow up ]
    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.

  9. Environmental Constraints One Subscale of the SFAB [ Time Frame: end of study at 90 day follow up ]
    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.

  10. Environmental Constraints Two Subscale of the SFAB [ Time Frame: end of study at 90 day follow up ]
    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.

  11. Environmental Constraints Three Subscale of the SFAB [ Time Frame: end of study at 90 day follow up ]
    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

  12. Habits Subscale of the SFAB [ Time Frame: end of study at the 90 day follow up ]
    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.

  13. Intentions Subscale of the SFAB [ Time Frame: end of study at 90 day follow up ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Are 18 years of age or older;
  2. Currently work in the emergency medicine setting as an emergency physician, emergency nurse, or emergency medical technician (EMT) / paramedic worker;
  3. Currently working shifts as part of your employment in the emergency medicine setting;
  4. Have a cell-phone / smartphone that can receive and send text-messages;
  5. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063737


Locations
Layout table for location information
United States, Pennsylvania
University of Pittsburgh Department of Emergency Medicine School of Medicine
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Investigators
Layout table for investigator information
Principal Investigator: Daniel Patterson, PhD University of Pittsburgh Department of Emergency Medicine School of Medicine

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Daniel Patterson, PhD, NREMT-P, Assistant Professor of Emergency Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02063737    
Other Study ID Numbers: PRO13120428
First Posted: February 14, 2014    Key Record Dates
Results First Posted: July 13, 2015
Last Update Posted: August 5, 2015
Last Verified: July 2015
Keywords provided by Daniel Patterson, PhD, NREMT-P, University of Pittsburgh:
Shift work
Fatigue
Sleepiness
Injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue
Signs and Symptoms