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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
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sleep Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 17, 2020
    Last Updated
    July 25, 2023
    Sponsor
    Brigham and Women's Hospital
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    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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