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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: Personalized OSA messages; Other: Control

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will receive the personalized OSA messages.	Behavioral: Personalized OSA messages; 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.
Placebo Comparator: Control; Placebo participants will receive no treatment during the experiment.	Other: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Measures

Outcome Measure	Measure Description	Time Frame
Change in OSA general knowledge as measured by the SOFHL.	OSA general knowledge will be assessed with the validated 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.
Change in Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS).	Daytime sleepiness will be assessed with the validated 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..
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.	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.

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Rebecca Robbins, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: 2019P003171; K01HL150339 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No