Studies
| Study First Submitted Date | 2020-08-17 |
| Study First Posted Date | 2020-08-19 |
| Last Update Posted Date | 2023-07-27 |
| Start Month Year | June 1, 2024 |
| Primary Completion Month Year | December 31, 2026 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-07-27 |
Conditions
| Sequence: | 51805642 |
| Name | Sleep Disorder |
| Downcase Name | sleep disorder |
Id Information
| Sequence: | 39867489 |
| Id Source | org_study_id |
| Id Value | 2020P002448 |
Design Groups
| Sequence: | 55225724 | Sequence: | 55225725 |
| Group Type | Experimental | Group Type | No Intervention |
| Title | Experimental (Early Education) | Title | Control (Later education) |
| 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. | Description | Firefighters in station randomized to the control condition will not receive SHEP prior to the data collection. |
Interventions
| Sequence: | 52127315 |
| Intervention Type | Behavioral |
| Name | Sleep Health Education Program (SHEP) |
| Description | Sleep Health Education Program (SHEP) including screening for common sleep disorders |
Design Outcomes
| Sequence: | 176200448 | Sequence: | 176200449 | Sequence: | 176200450 | Sequence: | 176200451 | Sequence: | 176200452 | Sequence: | 176200453 | Sequence: | 176200454 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Evaluation of sleep disorder | Measure | Diagnosis of sleep disorder | Measure | Treatment of sleep disorder | Measure | Injuries | Measure | Disability days | Measure | Motor vehicle crashes | Measure | Near crashes |
| Time Frame | 12 months (on end-of-year questionnaire) | Time Frame | 12 months (on end-of-year questionnaire) | Time Frame | 12 months (on end-of-year questionnaire) | Time Frame | Over 12 months (The number of injuries as documented in the fire department database) | Time Frame | Over 12 months (The number of injuries as documented in the fire department database) | Time Frame | Over 12 months, reported on monthly surveys | Time Frame | Over 12 months, reported on monthly surveys |
| Description | Evaluation of sleep disorder | Description | Diagnosis of sleep disorder | Description | Treatment of sleep disorder | Description | Injuries | Description | Disability days | Description | Motor vehicle crashes (exploratory aim) | Description | Near crashes (exploratory aim) |
Browse Conditions
| Sequence: | 192014089 | Sequence: | 192014090 | Sequence: | 192014091 | Sequence: | 192014092 | Sequence: | 192014093 |
| Mesh Term | Sleep Wake Disorders | Mesh Term | Parasomnias | Mesh Term | Nervous System Diseases | Mesh Term | Neurologic Manifestations | Mesh Term | Mental Disorders |
| Downcase Mesh Term | sleep wake disorders | Downcase Mesh Term | parasomnias | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | mental disorders |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 47978467 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Brigham and Women’s Hospital |
Central Contacts
| Sequence: | 11935194 | Sequence: | 11935195 |
| Contact Type | primary | Contact Type | backup |
| Name | Laura Barger, PhD | Name | Jason Sullivan |
| Phone | 530-753-2876 | ||
| lkbarger@hms.harvard.edu | jsullivan@rics.bwh.harvard.edu | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 67706865 |
| Design Group Id | 55225724 |
| Intervention Id | 52127315 |
Eligibilities
| Sequence: | 30550612 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 80 Years |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria: Firefighters working in one of the two fire departments selected for study Exclusion Criteria: None |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254231516 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Maximum Age Num | 80 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 5 |
| Number Of Secondary Outcomes To Measure | 2 |
Designs
| Sequence: | 30298984 |
| Allocation | Randomized |
| Intervention Model | Sequential Assignment |
| Observational Model | |
| Primary Purpose | Screening |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 28677549 |
| Responsible Party Type | Principal Investigator |
| Name | Laura K. Barger |
| Title | Principal Investigator |
| Affiliation | Brigham and Women’s Hospital |
Ipd Information Types
| Sequence: | 3314719 | Sequence: | 3314720 | Sequence: | 3314721 |
| Name | Study Protocol | Name | Statistical Analysis Plan (SAP) | Name | Informed Consent Form (ICF) |