Design and Usability Testing of a Tailored Intervention About Sleep and Sleep Disorders Among Transportation Workers
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized OSA messages
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Access to a smartphone device
- Commitment to completing all study activities
- Score 4 or higher (mild or higher on OSA risk) according to the Apnea Risk Evaluation System (ARES) questionnaire.
Exclusion Criteria:
- Significant medical or psychiatric illness according to the PROMIS Short Form (SF-12)
- No OSA risk (a score below 4 on the ARES).
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Participants will receive the personalized OSA messages.
Placebo participants will receive no treatment during the experiment.
Outcomes
Primary Outcome Measures
Change in OSA self-management efficacy as measured by the Survey of OSA Functional Health Literacy (SOFHL)
OSA self-management efficacy will be examined using the SOFHL
Secondary Outcome Measures
Change in OSA general knowledge as measured by the SOFHL.
OSA general knowledge will be assessed with the validated SOFHL.
Change in Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS).
Daytime sleepiness will be assessed with the validated ESS.
Change in Attentional Failures as measured by previously validated questions assessing Attentional Failures.
Attentional failures (e.g., near miss accidents) will be measured via self-report.
Full Information
NCT ID
NCT05039528
First Posted
July 12, 2021
Last Updated
July 6, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05039528
Brief Title
Design and Usability Testing of a Tailored Intervention About Sleep and Sleep Disorders Among Transportation Workers
Official Title
Design and Usability Testing of a Tailored Intervention to Increase Awareness About Sleep and Sleep Disorders Among Transportation Workers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this protocol is to conduct a focus group to identify OSA beliefs, attitudes, and knowledge among employees in the transportation industry on shift schedules.
Detailed Description
Transportation shift workers (TSW, e.g., overnight, on-call, or rotating) have been identified as a high-risk group for health conditions (e.g., obesity, cardiovascular disease). Also, TSW are at risk for obstructive sleep apnea (OSA). According to one study, approximately 36% of TSWs have OSA, a condition that exacerbates health risks and daytime sleepiness. A recent report from the American Academy of Sleep Medicine (AASM) showed that those with untreated OSA cost on average $4,261 more than those without OSA. Also concerning, workers with OSA who are non-adherent to recommended OSA treatment (i.e., continuous positive airway pressure, CPAP) are at particularly high risk for motor vehicle accidents compared to those who are adherent.
This protocol outlines focus groups that will aim to identify knowledge, attitudes, and beliefs about OSA among TSW. Results of these focus groups will be used in future research to design a tailored website for relaying OSA information to TSW.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A 2-month pre-post pilot study will be conducted. Two worksites will be selected at random then randomized to either the tailored (intervention) or non-tailored (control) groups. Participants who fit the eligibility criteria will be recruited from each worksite and assigned to the study arm corresponding to their worksite (20 per worksite for a total of 40 participants).
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will receive the personalized OSA messages.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo participants will receive no treatment during the experiment.
Intervention Type
Behavioral
Intervention Name(s)
Personalized OSA messages
Intervention Description
Participants will receive personalized OSA messages designed to nudge and navigate them toward evaluation and treatment for OSA. Participants will complete questionnaires at baseline and at study follow-up.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants will complete questionnaires at baseline and at study follow-up. At the end of the study period, participants will receive the OSA message intervention.
Primary Outcome Measure Information:
Title
Change in OSA self-management efficacy as measured by the Survey of OSA Functional Health Literacy (SOFHL)
Description
OSA self-management efficacy will be examined using the SOFHL
Time Frame
The SOFHL will be administered at baseline and post-intervention. Change in SOFHL score on self-management efficacy will be computed by comparing responses at baseline and post-intervention.
Secondary Outcome Measure Information:
Title
Change in OSA general knowledge as measured by the SOFHL.
Description
OSA general knowledge will be assessed with the validated SOFHL.
Time Frame
The SOFHL will be administered at baseline and post-intervention. Change in SOFHL score on OSA general knowledge will be computed by comparing responses at baseline and post-intervention.
Title
Change in Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS).
Description
Daytime sleepiness will be assessed with the validated ESS.
Time Frame
Sleepiness will be assessed at baseline and post-intervention. Change in daytime sleepiness will be computed by comparing responses at baseline and post-intervention..
Title
Change in Attentional Failures as measured by previously validated questions assessing Attentional Failures.
Description
Attentional failures (e.g., near miss accidents) will be measured via self-report.
Time Frame
Attentional failures will be measured at baseline and post-intervention.Change in attentional failures will be computed by comparing responses at baseline and follow-up.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Access to a smartphone device
Commitment to completing all study activities
Score 4 or higher (mild or higher on OSA risk) according to the Apnea Risk Evaluation System (ARES) questionnaire.
Exclusion Criteria:
Significant medical or psychiatric illness according to the PROMIS Short Form (SF-12)
No OSA risk (a score below 4 on the ARES).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Robbins, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Design and Usability Testing of a Tailored Intervention About Sleep and Sleep Disorders Among Transportation Workers
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