Design and Usability Testing of a Tailored Intervention About Sleep and Sleep Disorders Among Transportation Workers

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: Personalized OSA messages; Other: Control

• Registration Number: NCT05039528
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-09
• Study Start: 2022-10-01
• Status Verified: 2024-07
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Age 18 years or older
2. Access to a smartphone device
3. Commitment to completing all study activities
4. Score 4 or higher (mild or higher on OSA risk) according to the Apnea Risk Evaluation System (ARES) questionnaire.

Exclusion Criteria

1. Significant medical or psychiatric illness according to the PROMIS Short Form (SF-12)
2. No OSA risk (a score below 4 on the ARES).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Personalized OSA messages	Participants will receive the personalized OSA messages.
Control	Control	Placebo participants will receive no treatment during the experiment.

Primary Outcome Measures

Name	Time	Method
Change in OSA self-management efficacy as measured by the Survey of OSA Functional Health Literacy (SOFHL)	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.	OSA self-management efficacy will be examined using the SOFHL

Secondary Outcome Measures

Name	Time	Method
Change in OSA general knowledge as measured by the SOFHL.	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.	OSA general knowledge will be assessed with the validated SOFHL.
Change in Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS).	Sleepiness will be assessed at baseline and post-intervention. Change in daytime sleepiness will be computed by comparing responses at baseline and post-intervention..	Daytime sleepiness will be assessed with the validated ESS.
Change in Attentional Failures as measured by previously validated questions assessing Attentional Failures.	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.	Attentional failures (e.g., near miss accidents) will be measured via self-report.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States