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The EMS Sleep Health Study: A Randomized Controlled Trial

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: 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

Tracking Information
First Submitted Date  ICMJE January 2, 2020
First Posted Date  ICMJE January 6, 2020
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE February 24, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The EMS Sleep Health Study: A Randomized Controlled Trial
Official Title  ICMJE The EMS Sleep Health and Fatigue Study: A Randomized Controlled Trial
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Unblinded
Primary Purpose: Other
Condition  ICMJE
  • Sleep Quality
  • Fatigue
Intervention  ICMJE Other: Sleep Health Education
Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Sleep Health Education
  • 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..
    Intervention: Other: Sleep Health Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2020)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04218279
Other Study ID Numbers  ICMJE STUDY19080090
DTNH2215R00029 ( Other Grant/Funding Number: National Highway Traffic Safety Administration (NHTSA) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Responsible Party Daniel Patterson, PhD, NRP, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • National Highway Traffic Safety Administration (NHTSA)
  • National Association of State EMS Officials (NASEMSO)
Investigators  ICMJE
Principal Investigator: Daniel Patterson University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP