FatigueEarly Phase 1SleepTrackTXTNCT02063737
SleepTrackTXT Feasibility and Pilot Study
A Early Phase 1 study testing Text-message assessments only and Text-message interventions for high level fatigue in people with Fatigue, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Text-message assessments only and Text-message interventions for high level fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2014
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?
Who cannot join
- 1: Those that do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Department of Emergency Medicine School of Medicine
Pittsburgh, Pennsylvania, 15260
About this study
Official title: The Sleep Track Text Pilot Trial in Emergency Care Clinicians
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.
Read the detailed description
More than half (55%) of Emergency Medical Services (EMS) shift workers report severe mental and physical fatigue while at work,(Patterson et al, 2012) 36% report excessive daytime sleepiness,(Pirrallo et al; 2012) and 60% poor sleep quality.(Patterson et al; 2012) Sleepiness or fatigue while on duty can result in injuries to EMS workers and medical errors for patients.(Patterson et al; 2012) The investigators' recent research shows that odds of injury among fatigued EMS workers are 1.9 times higher than non-fatigued workers.(Patterson et al; 2012) Additional data show that other emergency workers (e.g., emergency physicians and nurses) are vulnerable to sleepiness and fatigue while at work.(Fisman et al; 2007; Machi et al; 2012; Thomas et al; 2006; Geiger-Brown et al; 2012).
There are a number of individual and system factors that influence sleepiness and fatigue during shift work for emergency workers. Individual factors include sleep hygiene, medical conditions like obstructive sleep apnea, and other factors.(Schaefer et al; 2012; Simon et al; 2012) System factors include shift length, patient care intensity, and workload. Many factors are modifiable, yet some are more difficult than others to change or control. Reducing shift length and customary patterns of shift work, such as 12-hr and 24-hr shifts, is not feasible for many employers and shift workers in the emergency medicine care setting. In some locations, >80% of EMS workers hold multiple jobs, 40% work more than 16 shifts per month, and many accumulate unsafe amounts of overtime in order to make a livable wage.(Patterson et al, 2010; Patterson et al, 2012; Bauder 2012) Other shift workers in emergency care settings face the same or similar obstacles as do EMS shift workers.
An objective of this research study is to pilot test real-time assessment of emergency care worker sleepiness and fatigue. The investigators seek to determine if text-messaging fatigue-reduction strategies to emergency care workers that report a high-level of sleepiness or fatigue at the start or during their shift reduces perceived sleepiness or fatigue at the end of shift. A long term goal of this research is to determine if this innovative text-messaging tool can be used to reduce the likelihood of fatigue-related injury among emergency care shift workers.
Aim 1: To determine if real-time assessments of perceived sleepiness and fatigue using text-messaging impacts a worker'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.
Rationale: The investigators recognize that emergency care shift workers hold different beliefs and attitudes about the risk of sleepiness and fatigue on duty and are at different stages of adopting risk-reduction behaviors. Behavioral research shows that modifying one or more of these factors can impact future behavior and potentially reduce risk over the long term. Approach: The investigators have developed a list of candidate items that operationalize the Integrative Model of Behavioral Prediction. The investigators will administer these candidate items at baseline and again at the end of the study period to assess impact.
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.
Approach: At baseline, the investigators will randomly assign 100 emergency care workers to one of two groups (the control group or intervention group). The control group (n=50 / 50%) will receive standard text-message questions of sleepiness and fatigue at the beginning, during, and end of shift. The other 50% (n=50) will be assigned to our intervention group and receive the same text-message questions as the control group, as well as additional text-messages that include strategies that the investigators hypothesize will lead to a reduction in perceived sleepiness or fatigue at the end of shift work. With 100 EMS workers (50% intervention / 50% control), the investigators have 80% power to detect a difference (effect size of 0.78) in the self-reported fatigue levels reported at the end of shift by the control and intervention groups. The investigators will collect data over a 90-day study period.
Eligibility Criteria include:
- The study subject must be 18 years of age or older;
- The study subject must currently work in the emergency medicine setting as an emergency physician, emergency nurse, or emergency medical technician (EMT) / paramedic worker;
- The study subject must work shifts as part of your employment in the emergency medicine setting;
- The study subject must have a cell-phone / smartphone that can receive and send text-messages;
- The study subject must be willing to take part in a research study where he/she is required to send and receive multiple text-messages at the start, during, and end of scheduled shift work?
- Conditions
- Fatigue
- Being tested
- Text-message assessments only, Text-message interventions for high level fatigue
- Keywords
- Shift work, Fatigue, Sleepiness, Injury
- Medical subject headings
- Fatigue, Sleepiness, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text-message assessments onlyBehavioural
Text message assessments only. No intervention for high level fatigue.
Text-message interventions for high level fatigueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | 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. Receives: Behavioral: Text-message assessments only |
| Intervention Group | Experimental | 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. Receives: Behavioral: Text-message interventions for high level fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Fatigue at End of Shift Work
Self-reported fatigue based on scale ranging from 0 (Not At All) to 5 (Very Much).
Measured: At the end of scheduled work shifts during a 90 day study period
Secondary outcomes (13)
Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool
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.
Measured: Assessed at the end of 90-day study period
Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool
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.
Measured: end of study at 90 day follow up
Normative Beliefs Scale One Subscale of the SFAB
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.
Measured: end of study at 90 day follow up
Normative Beliefs Scale Two Subscale of the SFAB
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.
Measured: end of study at 90 day follow up
Self Efficacy Subscale of the SFAB
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.
Measured: end of study at 90 day follow up
Knowledge-one Subscale of SFAB
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.
Measured: end of study at 90 day follow up
Knowledge-two Subscale of the SFAB
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.
Measured: end of study at 90 day follow up
Importance Subscale of SFAB
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.
Measured: end of study at 90 day follow up
Environmental Constraints One Subscale of the SFAB
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.
Measured: end of study at 90 day follow up
Environmental Constraints Two Subscale of the SFAB
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.
Measured: end of study at 90 day follow up
Environmental Constraints Three Subscale of the SFAB
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
Measured: end of study at 90 day follow up
Habits Subscale of the SFAB
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.
Measured: end of study at the 90 day follow up
Intentions Subscale of the SFAB
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).
Measured: end of study at 90 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Patterson, PhD, NREMT-P, University of Pittsburgh
- Investigators
- Daniel Patterson, PhD, Principal investigator, University of Pittsburgh Department of Emergency Medicine School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063737
- Sponsor's protocol ID
- PRO13120428
- Acronym
- SleepTrackTXT
- Status last verified
- Jul 2015
- First submitted
- 10 Jan 2014
- Last updated
- 5 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Patterson PD, Moore CG, Weaver MD, Buysse DJ, Suffoletto BP, Callaway CW, Yealy DM. Mobile phone text messaging intervention to improve alertness and reduce sleepiness and fatigue during shiftwork among emergency medicine clinicians: study protocol for the SleepTrackTXT pilot randomized controlled trial. Trials. 2014 Jun 21;15:244. doi: 10.1186/1745-6215-15-244.
PubMed 24952387Patterson PD, Buysse DJ, Weaver MD, Callaway CW, Yealy DM. Recovery between Work Shifts among Emergency Medical Services Clinicians. Prehosp Emerg Care. 2015 Jul-Sep;19(3):365-75. doi: 10.3109/10903127.2014.995847. Epub 2015 Feb 6.
PubMed 25658148Patterson PD, Klapec SE, Weaver MD, Guyette FX, Platt TE, Buysse DJ. Differences in Paramedic Fatigue before and after Changing from a 24-hour to an 8-hour Shift Schedule: A Case Report. Prehosp Emerg Care. 2016;20(1):132-6. doi: 10.3109/10903127.2015.1025158. Epub 2015 May 15.
PubMed 25978152Patterson PD, Buysse DJ, Weaver MD, Doman JM, Moore CG, Suffoletto BP, McManigle KL, Callaway CW, Yealy DM. Real-time fatigue reduction in emergency care clinicians: The SleepTrackTXT randomized trial. Am J Ind Med. 2015 Oct;58(10):1098-113. doi: 10.1002/ajim.22503. Epub 2015 Aug 25.
PubMed 26305869Patterson PD, Moore CG, Guyette FX, Doman JM, Sequeira D, Werman HA, Swanson D, Hostler D, Lynch J, Russo L, Hines L, Swecker K, Runyon MS, Buysse DJ. Fatigue mitigation with SleepTrackTXT2 in air medical emergency care systems: study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):254. doi: 10.1186/s13063-017-1999-z.
PubMed 28583143
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sleep Track Text Pilot Trial in Emergency Care Clinicians
- ClinicalTrials.gov ID
- NCT02063737
- Acronym / sponsor ID
- SleepTrackTXT / PRO13120428
- Conditions
- Fatigue
- Keywords
- Shift work, Fatigue, Sleepiness, Injury
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Posted 13 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
More than half (55%) of Emergency Medical Services (EMS) shift workers report severe mental and physical fatigue while at work,(Patterson et al, 2012) 36% report excessive daytime sleepiness,(Pirrallo et al; 2012) and 60% poor sleep quality.(Patterson et al; 2012) Sleepiness or fatigue while on duty can result in injuries to EMS workers and medical errors for patients.(Patterson et al; 2012) The investigators' recent research shows that odds of injury among fatigued EMS workers are 1.9 times higher than non-fatigued workers.(Patterson et al; 2012) Additional data show that other emergency workers (e.g., emergency physicians and nurses) are vulnerable to sleepiness and fatigue while at work.(Fisman et al; 2007; Machi et al; 2012; Thomas et al; 2006; Geiger-Brown et al; 2012).
There are a number of individual and system factors that influence sleepiness and fatigue during shift work for emergency workers. Individual factors include sleep hygiene, medical conditions like obstructive sleep apnea, and other factors.(Schaefer et al; 2012; Simon et al; 2012) System factors include shift length, patient care intensity, and workload. Many factors are modifiable, yet some are more difficult than others to change or control. Reducing shift length and customary patterns of shift work, such as 12-hr and 24-hr shifts, is not feasible for many employers and shift workers in the emergency medicine care setting. In some locations, >80% of EMS workers hold multiple jobs, 40% work more than 16 shifts per month, and many accumulate unsafe amounts of overtime in order to make a livable wage.(Patterson et al, 2010; Patterson et al, 2012; Bauder 2012) Other shift workers in emergency care settings face the same or similar obstacles as do EMS shift workers.
An objective of this research study is to pilot test real-time assessment of emergency care worker sleepiness and fatigue. The investigators seek to determine if text-messaging fatigue-reduction strategies to emergency care workers that report a high-level of sleepiness or fatigue at the start or during their shift reduces perceived sleepiness or fatigue at the end of shift. A long term goal of this research is to determine if this innovative text-messaging tool can be used to reduce the likelihood of fatigue-related injury among emergency care shift workers.
Aim 1: To determine if real-time assessments of perceived sleepiness and fatigue using text-messaging impacts a worker'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.
Rationale: The investigators recognize that emergency care shift workers hold different beliefs and attitudes about the risk of sleepiness and fatigue on duty and are at different stages of adopting risk-reduction behaviors. Behavioral research shows that modifying one or more of these factors can impact future behavior and potentially reduce risk over the long term. Approach: The investigators have developed a list of candidate items that operationalize the Integrative Model of Behavioral Prediction. The investigators will administer these candidate items at baseline and again at the end of the study period to assess impact.
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.
Approach: At baseline, the investigators will randomly assign 100 emergency care workers to one of two groups (the control group or intervention group). The control group (n=50 / 50%) will receive standard text-message questions of sleepiness and fatigue at the beginning, during, and end of shift. The other 50% (n=50) will be assigned to our intervention group and receive the same text-message questions as the control group, as well as additional text-messages that include strategies that the investigators hypothesize will lead to a reduction in perceived sleepiness or fatigue at the end of shift work. With 100 EMS workers (50% intervention / 50% control), the investigators have 80% power to detect a difference (effect size of 0.78) in the self-reported fatigue levels reported at the end of shift by the control and intervention groups. The investigators will collect data over a 90-day study period.
Eligibility Criteria include:
- The study subject must be 18 years of age or older;
- The study subject must currently work in the emergency medicine setting as an emergency physician, emergency nurse, or emergency medical technician (EMT) / paramedic worker;
- The study subject must work shifts as part of your employment in the emergency medicine setting;
- The study subject must have a cell-phone / smartphone that can receive and send text-messages;
- The study subject must be willing to take part in a research study where he/she is required to send and receive multiple text-messages at the start, during, and end of scheduled shift work?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Behavioral: Text-message assessments onlyThe 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. |
| Intervention Group | Experimental | Behavioral: Text-message interventions for high level fatigueThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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?
Key exclusion criteria (1 listed)
- 1: Those that do not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text-message assessments onlyText message assessments only. No intervention for high level fatigue. | Behavioural | Control Group |
| Text-message interventions for high level fatigueIntervention 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. | Behavioural | Intervention Group |
Primary outcome
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).
13 secondary outcomes
Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool
Time frame: Assessed at the end of 90-day study period
Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool
Time frame: end of study at 90 day follow up
Normative Beliefs Scale One Subscale of the SFAB
Time frame: end of study at 90 day follow up
Normative Beliefs Scale Two Subscale of the SFAB
Time frame: end of study at 90 day follow up
Self Efficacy Subscale of the SFAB
Time frame: end of study at 90 day follow up
Knowledge-one Subscale of SFAB
Time frame: end of study at 90 day follow up
Knowledge-two Subscale of the SFAB
Time frame: end of study at 90 day follow up
Importance Subscale of SFAB
Time frame: end of study at 90 day follow up
Environmental Constraints One Subscale of the SFAB
Time frame: end of study at 90 day follow up
Environmental Constraints Two Subscale of the SFAB
Time frame: end of study at 90 day follow up
Environmental Constraints Three Subscale of the SFAB
Time frame: end of study at 90 day follow up
Habits Subscale of the SFAB
Time frame: end of study at the 90 day follow up
Intentions Subscale of the SFAB
Time frame: end of study at 90 day follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24952387Patterson PD, Moore CG, Weaver MD, Buysse DJ, Suffoletto BP, Callaway CW, Yealy DM. Mobile phone text messaging intervention to improve alertness and reduce sleepiness and fatigue during shiftwork among emergency medicine clinicians: study protocol for the SleepTrackTXT pilot randomized controlled trial. Trials. 2014 Jun 21;15:244. doi: 10.1186/1745-6215-15-244.
- Results publication: PubMed 25658148Patterson PD, Buysse DJ, Weaver MD, Callaway CW, Yealy DM. Recovery between Work Shifts among Emergency Medical Services Clinicians. Prehosp Emerg Care. 2015 Jul-Sep;19(3):365-75. doi: 10.3109/10903127.2014.995847. Epub 2015 Feb 6.
- Results publication: PubMed 25978152Patterson PD, Klapec SE, Weaver MD, Guyette FX, Platt TE, Buysse DJ. Differences in Paramedic Fatigue before and after Changing from a 24-hour to an 8-hour Shift Schedule: A Case Report. Prehosp Emerg Care. 2016;20(1):132-6. doi: 10.3109/10903127.2015.1025158. Epub 2015 May 15.
- Results publication: PubMed 26305869Patterson PD, Buysse DJ, Weaver MD, Doman JM, Moore CG, Suffoletto BP, McManigle KL, Callaway CW, Yealy DM. Real-time fatigue reduction in emergency care clinicians: The SleepTrackTXT randomized trial. Am J Ind Med. 2015 Oct;58(10):1098-113. doi: 10.1002/ajim.22503. Epub 2015 Aug 25.
- Derived from this study: PubMed 28583143Patterson PD, Moore CG, Guyette FX, Doman JM, Sequeira D, Werman HA, Swanson D, Hostler D, Lynch J, Russo L, Hines L, Swecker K, Runyon MS, Buysse DJ. Fatigue mitigation with SleepTrackTXT2 in air medical emergency care systems: study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):254. doi: 10.1186/s13063-017-1999-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Patterson, PhD principal investigator
University of Pittsburgh Department of Emergency Medicine School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Text-message assessments only and Text-message interventions for high level fatigue in people with Fatigue, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Fatigue at End of Shift Work (time frame: At the end of scheduled work shifts during a 90 day study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063737, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.