Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ...
Primary Purpose
Sleep Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sleep Health Education Program (SHEP)
Sponsored by
About this trial
This is an interventional screening trial for Sleep Disorder
Eligibility Criteria
Inclusion Criteria:
- Firefighters working in one of the two fire departments selected for study
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental (Early Education)
Control (Later education)
Arm Description
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.
Firefighters in station randomized to the control condition will not receive SHEP prior to the data collection.
Outcomes
Primary Outcome Measures
Evaluation of sleep disorder
Evaluation of sleep disorder
Diagnosis of sleep disorder
Diagnosis of sleep disorder
Treatment of sleep disorder
Treatment of sleep disorder
Injuries
Injuries
Disability days
Disability days
Secondary Outcome Measures
Motor vehicle crashes
Motor vehicle crashes (exploratory aim)
Near crashes
Near crashes (exploratory aim)
Full Information
NCT ID
NCT04519177
First Posted
August 17, 2020
Last Updated
July 25, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04519177
Brief Title
Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ...
Official Title
Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental (Early Education)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (Later education)
Arm Type
No Intervention
Arm Description
Firefighters in station randomized to the control condition will not receive SHEP prior to the data collection.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Health Education Program (SHEP)
Intervention Description
Sleep Health Education Program (SHEP) including screening for common sleep disorders
Primary Outcome Measure Information:
Title
Evaluation of sleep disorder
Description
Evaluation of sleep disorder
Time Frame
12 months (on end-of-year questionnaire)
Title
Diagnosis of sleep disorder
Description
Diagnosis of sleep disorder
Time Frame
12 months (on end-of-year questionnaire)
Title
Treatment of sleep disorder
Description
Treatment of sleep disorder
Time Frame
12 months (on end-of-year questionnaire)
Title
Injuries
Description
Injuries
Time Frame
Over 12 months (The number of injuries as documented in the fire department database)
Title
Disability days
Description
Disability days
Time Frame
Over 12 months (The number of injuries as documented in the fire department database)
Secondary Outcome Measure Information:
Title
Motor vehicle crashes
Description
Motor vehicle crashes (exploratory aim)
Time Frame
Over 12 months, reported on monthly surveys
Title
Near crashes
Description
Near crashes (exploratory aim)
Time Frame
Over 12 months, reported on monthly surveys
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Firefighters working in one of the two fire departments selected for study
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Barger, PhD
Phone
530-753-2876
Email
lkbarger@hms.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Sullivan
Email
jsullivan@rics.bwh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ...
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