The EMS Sleep Health Study: A Randomized Controlled Trial

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04218279
• Other study ID #: STUDY19080090
• Secondary ID: DTNH2215R00029
• Status: Terminated
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: April 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 678
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Sleep Quality

Intervention

Other:
• Sleep Health Education
Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Association of State EMS Officials (NASEMSO), National Highway Traffic Safety Administration (NHTSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Sleep Quality at 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	Change From Baseline in Fatigue at 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