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

Study Overview
=================
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.

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

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Behavioral: Personalized OSA messages
* Other: Control


Participation Criteria
=================
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).
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will receive the personalized OSA messages. | Behavioral: Personalized OSA messages<br>* 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.<br>|
| Placebo Comparator: Control<br>Placebo participants will receive no treatment during the experiment. | Other: Control<br>* 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.<br>|

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. |