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

NCT05039528 | Completed DMC

• 2 other identifiers: 2019P003171K01HL150339
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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..

• 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.

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive the personalized OSA messages.

Behavioral: Personalized OSA messages

Control

PLACEBO COMPARATOR

Placebo participants will receive no treatment during the experiment.

Other: Control

Interventions

Personalized OSA messages 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.

Intervention

Control 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.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Rebecca Robbins, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine at Harvard Medical Scool and Associate Scientist at Brigham & Women's Hospital

Model Details: 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).

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: September 9, 2021
• Study Start: October 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)