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The EMS Sleep Health Study: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT04218279
Recruitment Status : Active, not recruiting
First Posted : January 6, 2020
Last Update Posted : April 6, 2021
Sponsor:
Collaborators:
National Highway Traffic Safety Administration (NHTSA)
National Association of State EMS Officials (NASEMSO)
Information provided by (Responsible Party):
Daniel Patterson, PhD, NRP, University of Pittsburgh

Brief Summary:
The experiment seeks to determine the impact of a sleep health and fatigue education and training program on diverse indicators of sleep and fatigue among Emergency Medical Services (EMS) personnel. The overarching goals of this research study are to [1] enhance our understanding of the relationships between shift work, sleep, and fatigue in EMS operations; and [2] determine whether or not providing education and training to EMS personnel on the importance of sleep health and dangers of fatigue impact indicators of sleep and fatigue. The investigators will accomplish these goals by using a cluster-randomized trial study design with a wait-list control group.

Condition or disease Intervention/treatment Phase
Sleep Quality Fatigue Other: Sleep Health Education Not Applicable

Detailed Description:

The overarching goals of this research study are to:

  1. enhance our understanding of the relationships between shift work, sleep, and fatigue in EMS operations; and
  2. determine whether or not providing education and training to EMS personnel on the importance of sleep health and dangers of fatigue impact indicators of sleep and fatigue.

The investigators will recruit EMS nationwide for EMS agencies to participate in this study and focus on moderately sized EMS agencies with between 50 and 300 employees (yet we will not outright exclude smaller or larger organizations). Agencies that run dual ground-based and air-medical EMS services are eligible. Maximum enrollment at the agency-level is n=30 EMS agencies. Agencies will be randomized upon enrollment to one of two arms: [1] Intervention group; or [2] the Wait-List control group. The intervention group will receive immediate access to the intervention materials (the 10 brief Sleep Health Education Modules). The wait-list control group will receive access to intervention materials at 3 months post enrollment/baseline.

Within each agency, the investigators will recruit individual EMS clinicians to participate. Goal enrollment within each agency is a minimum of 30 and a maximum of 50 EMS clinicians.

All individual EMS clinician participants will undergo informed consent, answer a baseline survey, and be queried via mobile phone text message at regular intervals which will begin upon enrollment. These mobile phone text message queries will assess indicators of sleep and fatigue. All participants will be asked to answer two follow up surveys at 3 months and 6 months. The total duration of study participation is 6 months. The primary outcome of interest is sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcome of interest is fatigue as measured by the Chalder Fatigue Questionnaire (CFQ).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Unblinded
Primary Purpose: Other
Official Title: The EMS Sleep Health and Fatigue Study: A Randomized Controlled Trial
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Sleep Health Education
At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue.
Other: Sleep Health Education
Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.

Active Comparator: Wait List Control
At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue..
Other: Sleep Health Education
Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.




Primary Outcome Measures :
  1. Change from baseline in Sleep Quality at 3 months [ Time Frame: baseline to 3 months ]
    Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) tool. Scores range from 0-21 with scores greater than or equal to 6 classified as poor sleep quality.

  2. Change from baseline in Sleep Quality at 6 months [ Time Frame: baseline to 6 months ]
    Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) tool. Scores range from 0-21 with scores greater than or equal to 6 classified as poor sleep quality.


Secondary Outcome Measures :
  1. Change from baseline in Fatigue at 3 months [ Time Frame: baseline to 3 months ]
    Fatigue will be measured with the Chalder Fatigue Questionnaire (CFQ). The CFQ is a brief 11-item survey tool that measures mental and physical fatigue with scores ranging from 0-11. Scores 4 or greater indicate severe fatigue.

  2. Change from baseline in Fatigue at 6 months [ Time Frame: baseline to 6 months ]
    Fatigue will be measured with the Chalder Fatigue Questionnaire (CFQ). The CFQ is a brief 11-item survey tool that measures mental and physical fatigue with scores ranging from 0-11. Scores 4 or greater indicate severe fatigue.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • EMS Personnel:

    1. 18 years of age or older
    2. Currently working as an EMS clinician
    3. Working a minimum of one shift a week
    4. Working & residing in the United States
    5. Working at one of the EMS organizations that agreed to participate in this study
    6. Have a cellular, mobile, or smart phone that can send and receive text messages
    7. Willing to answer online surveys and respond to text-message queries for seven days in a row every third week of the month for a total of 24 weeks/6 months

Exclusion Criteria:

  • EMS Personnel:

    1. Individuals <18 years of age
    2. Not currently working as an EMS clinician
    3. Does not work a minimum of one shift a week
    4. Does not work and/reside in the United States
    5. Does not work at one of the EMS organizations that agreed to participate in this study
    6. Does not have a cellular, mobile, or smart phone that can send and receive text messages
    7. Is not willing to answer online surveys and respond to text-message queries for seven days in a row every third week of the month for a total of 24 weeks/6 months.

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): NCT04218279


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
National Highway Traffic Safety Administration (NHTSA)
National Association of State EMS Officials (NASEMSO)
Investigators
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Principal Investigator: Daniel Patterson University of Pittsburgh
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Responsible Party: Daniel Patterson, PhD, NRP, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04218279    
Other Study ID Numbers: STUDY19080090
DTNH2215R00029 ( Other Grant/Funding Number: National Highway Traffic Safety Administration (NHTSA) )
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual de-identified participant data collected during the trial will be shared with the funding organization (the National Highway Traffic Safety Administration (NHTSA)) and with researchers who provide a methodologically sound proposal and have been approved by the funding organization and by the University of Pittsburgh.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The de-identified data will be made available immediately following publication and upon approval from the funding organization. No end date.
Access Criteria: Access will be provided to researchers who provide a methodologically sound proposal and have been approved by the funding organization and by the University of Pittsburgh.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue