Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ...

Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability

The investigators have shown that sleep health education and sleep disorders screening improve health and safety of employees. There is potential to increase the benefits of the sleep health education and screening program if more firefighters are evaluated, diagnosed and referred for treatment. Investigators will evaluate whether firefighters in stations randomized to participate in the Sleep Health and Education Program (SHEP) intervention will have improved health and safety outcomes as compared to firefighters in stations randomized to the control condition.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disorder
• Intervention / Treatment: Behavioral: Sleep Health Education Program (SHEP)

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Barger, PhD; Phone Number: 530-753-2876; Email: lkbarger@hms.harvard.edu
• Study Contact Backup: Name: Jason Sullivan; Email: jsullivan@rics.bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Firefighters working in one of the two fire departments selected for study

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental (Early Education); Firefighters in station randomized to the experimental (early education) will receive the sleep health education program (SHEP) including screening for common sleep disorders. Those found at high risk will be given information about seeking further evaluation, diagnosis and treatment, if necessary.	Behavioral: Sleep Health Education Program (SHEP); Sleep Health Education Program (SHEP) including screening for common sleep disorders
No Intervention: Control (Later education); Firefighters in station randomized to the control condition will not receive SHEP prior to the data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of sleep disorder	Evaluation of sleep disorder	12 months (on end-of-year questionnaire)
Diagnosis of sleep disorder	Diagnosis of sleep disorder	12 months (on end-of-year questionnaire)
Treatment of sleep disorder	Treatment of sleep disorder	12 months (on end-of-year questionnaire)
Injuries	Injuries	Over 12 months (The number of injuries as documented in the fire department database)
Disability days	Disability days	Over 12 months (The number of injuries as documented in the fire department database)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor vehicle crashes	Motor vehicle crashes (exploratory aim)	Over 12 months, reported on monthly surveys
Near crashes	Near crashes (exploratory aim)	Over 12 months, reported on monthly surveys

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: 2020P002448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Results derived from the proposed work will be shared through presentation at research conferences as well as publication in peer-reviewed journals. We or the journal will submit an electronic version of all final manuscripts upon acceptance for publication to PubMed Central database, in compliance with NIH Policy. If required, published data will also be deposited in publicly available databases.

Per NIH Policy, we will make the database available to other investigators following publication of the final study results. The database will not contain identifying information per HIPAA regulations and permission will be obtained from participants to share their data with researchers outside the BWH.

Per Partners policies, any investigator or entity requesting the data must request the data in writing in an agreement outlining how the data will be used, protected, and maintained.

• IPD Sharing Time Frame: After publication of results.
• IPD Sharing Access Criteria: Per the NIH Policy on Data Sharing, we will make the database available to other investigators following publication of the final study results. The database will not contain identifying information per the regulations outlined in HIPPA, and permission will be obtained from study participants to share their data with researchers outside the Brigham and Women's Hospital. Per Partners HealthCare System policies, any investigator or entity requesting the data must request the data in writing in an agreement outlining how the data will be used, protected, and maintained, e.g., through a formal Data Use Agreement (DUA) negotiated by a Partners office or a template letter agreement signed by the sharing and receiving PIs.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; 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