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

NCT ID: NCT05039528

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-07-01

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Participants will receive the personalized OSA messages.

Group Type EXPERIMENTAL

Personalized OSA messages

Intervention Type BEHAVIORAL

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.

Control

Placebo participants will receive no treatment during the experiment.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Robbins

Assistant Professor of Medicine at Harvard Medical Scool and Associate Scientist at Brigham & Women's Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Robbins, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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K01HL150339

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019P003171

Identifier Type: -

Identifier Source: org_study_id

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