The EMS Sleep Health Study: A Randomized Controlled Trial

April 4, 2022 updated by: Daniel Patterson, PhD, NRP, University of Pittsburgh

The EMS Sleep Health and Fatigue Study: A Randomized Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

678

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Highway Traffic Safety Administration (NHTSA)
National Association of State EMS Officials (NASEMSO)

Investigators

  • Principal Investigator: Daniel Patterson, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2020

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19080090
  • DTNH2215R00029 (Other Grant/Funding Number: National Highway Traffic Safety Administration (NHTSA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Time Frame

The de-identified data will be made available immediately following publication and upon approval from the funding organization. No end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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