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关于运输工人睡眠和睡眠障碍的定制干预措施的设计和可用性测试

2026年9月30日 更新者:Rebecca Robbins、Brigham and Women's Hospital

旨在提高运输工人对睡眠和睡眠障碍意识的量身定制干预措施的设计和可用性测试

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

38

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

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).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention

Participants will receive the 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.

安慰剂比较:Control

Placebo participants will receive no treatment during the experiment.

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Obstructive Sleep Apnea (OSA) Self-efficacy
大体时间:Baseline and follow-up (approximately 2 months)

The Survey of Obstructive Sleep Apnea Functional Health Literacy (SOFHL) was administered, which includes two subscales, one for OSA Self-Efficacy and another for OSA Knowledge. The SOFHL can be scored by measuring the proportion of correct answers in each sub-scale (OSA Self-Efficacy and OSA Knowledge). The OSA Self-Efficacy subscale collects responses to 5 self-efficacy questions on 3-point scales from 1 "I am confident" to 2 "I am not sure" and 3 "I am not confident." Scores of 1 ("I am confident") indicate self-efficacy. To score OSA Self-Efficacy, the total number of questions that participants mark a response of "1" ("I am confident") are summed then divided by the total number of questions in the subscale (5) and multiplied by 100. The result is a total score with a minimum possible value of 0% and a maximum possible value of 100%. Lower scores (closer to 0%) indicate low OSA self-efficacy scores. Higher scores (closer to 100%) indicate higher OSA Self-efficacy.

Baseline and follow-up (approximately 2 months)

次要结果测量

结果测量
措施说明
大体时间
OSA Knowledge
大体时间:Baseline and follow-up (approximately 2 months)

The Survey of Obstructive Sleep Apnea Functional Health Literacy (SOFHL) was administered, which includes two subscales, one for OSA Self-Efficacy and another for OSA Knowledge. The SOFHL can be scored by measuring the proportion of correct answers in each sub-scale (OSA Self-Efficacy and OSA Knowledge). The OSA Knowledge subscale collects responses to 13 knowledge questions on 3-point scale from 1 ("I am confident this is true") to 2 ("I am not sure") and 3 ("I am confident this is not true"). To score OSA Knowledge, the total number of responses of 1 "I am confident this is true" are summed then divided by 13 and multiplied by 100. The result is a score with a minimum possible value of 0% and a maximum possible value of 100%. Lower scores (closer to 0%) indicate lower OSA knowledge while higher scores (closer to 100%) indicate higher OSA Knowledge.

Baseline and follow-up (approximately 2 months)
OSA Readiness to Change
大体时间:Baseline and follow-up (approximately 2 months)

OSA Readiness to Change: A measure of willingness to improve sleep and address sleep problems. OSA readiness to change will be measured with a 12-item questionnaire. Responses are captured on a 5-item scale from 1 "strongly disagree" to 5 "strongly agree." Responses are summed for a total score of readiness to change. Higher scores indicate higher levels of readiness to change.

Baseline and follow-up (approximately 2 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rebecca Robbins, PhD、Brigham and Women's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年10月1日

初级完成 (实际的)

2024年7月1日

研究完成 (实际的)

2024年7月1日

研究注册日期

首次提交

2021年7月12日

首先提交符合 QC 标准的

2021年9月2日

首次发布 (实际的)

2021年9月9日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2019P003171
  • K01HL150339 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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