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Operational Trial of Dayzz App

2022年6月16日 更新者:Laura K. Barger、Brigham and Women's Hospital
Sleep deficiency is a hidden cost of our 24-7 society, with 70% of Americans admitting that they routinely obtain insufficient sleep, 30% of US workers report sleeping less than 6 hours per night, and it is estimated that 50-70 million individuals have a sleep disorder. Undiagnosed and untreated sleep disorders are associated with poor health outcomes for the individual and generate substantial costs for the employer. Diminished alertness resulting from sleep deficiency or undiagnosed and untreated sleep disorders contributes to absenteeism, presenteeism (diminished work performance at work), health care expenditure, occupational injuries, workplace accidents, and commute-related motor vehicle crashes; all of which result in substantial direct and indirect costs. The investigators have shown that adverse impacts on employees and employers can be mitigated through a sleep health education and sleep disorder screening program which have been implemented in a variety of industries. Further, smartphone apps are becoming popular. Dayzz has created a personalized sleep training app that evaluates sleep issues and offers a holistic sleep improvement solution. It is unique in that the sleep app uses evidence-based, big-data-based algorithms to provide personalized sleep training plans. The sleep solutions are tailored to the individual user and leverages unique motivational strategies and continuous supportive messaging. The investigators hypothesize that the Dayzz app, offering a personalized, scientifically based sleep training plan, might further promote improved health, safety and well-being. This clinical trial will implement the sleep health education and sleep disorders screening program in combination with the Dayzz app.

研究概览

地位

完全的

干预/治疗

详细说明

Specifically, the investigators will test the hypotheses that:

Primary Aim 1: Early Dayzz participants who use the app will report positive changes in sleep behavior as compared to the Late Dayzz participants.

Primary Aim 2: Early Dayzz participants who use the app will have increased sleep duration and sleep quality as compared to the Late Dayzz participants.

Secondary Aim 1: Early Dayzz participants who use the app will have fewer unscheduled absences and higher performance/productivity as compared to the Late Dayzz participants.

Secondary Aim 2: Early Dayzz participants who use the app will have improved mood and alertness and increased energy as compared to the Late Dayzz participants.

Secondary Aim 3: Early Dayzz participants who use the app will report fewer adverse health and safety outcomes as compared to the Late Dayzz participants.

Secondary Aim 4: Early Dayzz participants who use the app will have lower health care costs over a 9-month follow-up period as compared to the Late Dayzz participants.

研究类型

介入性

注册 (实际的)

1355

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
        • Partners HealthCare

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

18年 及以上 (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:

  • Employee of Harvard University or Harvard-affiliated institution or hospital.
  • Nominally work a day schedule.
  • Own and use a smart phone.
  • Regularly use a smart phone app (i.e., once per week).

Exclusion Criteria:

  • Regularly work evening, night or rotating shifts.
  • Pregnant or breast-feeding.

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:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Early Dayzz
Participants receive a Sleep Health and Wellness education session and download the Dayzz app. Complete monthly questionnaires for up to 9 months and 2 weeks of sleep diaries.
Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution
无干预:Late Dayzz
Complete monthly questionnaires for up to 9 months and 2 weeks of sleep diaries. At the end of nine months, participants have the opportunity to receive a Sleep Health and Wellness education session.

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
Primary Aim 1: Sleep Behavior 1
大体时间:Up to 9 months
Sleep behaviors (e.g., sleep on a consistent schedule, sleep in later) will be self-reported on the end-of-study survey. 100 mm visual analog scales anchored with "Not at all" at 0 and "All the time" at 100 will be used. Higher scores indicate a better outcome.
Up to 9 months
Primary Aim 1: Sleep Behavior 2
大体时间:1 week of daily eDiary in both Month 1 and Month 3
Sleep behaviors will also be tracked on the eDiary (e.g., consistent sleep schedule, as calculated with the regularity index). The Sleep Regularity Index calculates the percentage probability of an individual being in the same state (asleep vs. awake) at any two time-points 24 h apart, averaged across the study. The index is scaled so that an individual who sleeps and wakes at exactly the same times each day scores 100 (better outcome), whereas an individual who sleeps and wakes at random scores 0 (worse outcome).
1 week of daily eDiary in both Month 1 and Month 3
Primary Aim 1: Sleep Behavior 3
大体时间:Up to 9 months
Outcomes in sleep behaviors will be further detailed by self-report by completing a checklist of potential positive changes. Participants will select the healthy sleep changes they have made while completing the protocol, "During this study, have you changed any sleep-related behaviors to improve your sleep since participating in the study (check all that apply)?" Higher numbers of positive changes selected indicate a better outcome.
Up to 9 months
Primary Aim 2: Sleep Duration
大体时间:1 week of daily eDiary in both Month 1 and Month 3
Sleep duration will be reported in the eDiary.
1 week of daily eDiary in both Month 1 and Month 3
Primary Aim 2: Sleep Quality
大体时间:Up to 9 months
Sleep quality will be measured with the Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The participant self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper. Minimum Score = 0 (better outcome); Maximum Score = 21 (worse outcome).
Up to 9 months

次要结果测量

结果测量
措施说明
大体时间
Secondary Aim 1: Absenteeism
大体时间:Up to 9 months
Unscheduled absences and disability day usage will be collected by self-report on the monthly questionnaires.
Up to 9 months
Secondary Aim 1: Performance/Productivity - Absenteeism
大体时间:Up to 9 months
World Health Organization Health Work Performance Questionnaire Short Form (HPQ) will be used to assess performance/productivity via 4-week absolute absenteeism. Absenteeism is scored in terms of hours lost per month, which is to say that a high score indicates a higher amount of absenteeism. The measure of absolute absenteeism is expressed in raw hours, with a negative lower bound (if the person works more than expected) and an upper bound equal to the number of hours the respondent is expected to work.
Up to 9 months
Secondary Aim 1: Performance/Productivity - Presenteeism
大体时间:Up to 9 months
World Health Organization Health Work Performance Questionnaire Short Form (HPQ) will be used to assess performance/productivity via absolute presenteeism. Presenteeism has a lower bound of 0 (total lack of performance during time on the job) and an upper bound of 100 (no lack of performance during time on the job). A higher score indicates a lower amount of lost performance.
Up to 9 months
Secondary Aim 2: Mood - Monthly questionnaire
大体时间:Up to 9 months
Mood will be self-reported via a 7-point Likert scale anchored at 0 with "Very poor" and 7 with "Very good." Higher numbers indicate better outcome.
Up to 9 months
Secondary Aim 2: Mood - eDiary
大体时间:1 week of daily eDiary in both Month 1 and Month 3
Mood will be self-reported via 100 mm visual analog scales anchored with "Sad" at 0 and "Happy" at 100. Higher scores indicate a better outcome.
1 week of daily eDiary in both Month 1 and Month 3
Secondary Aim 2: Alertness - Monthly questionnaire
大体时间:Up to 9 months
Alertness will be self-reported via a 7-point Likert scale anchored at 0 with "Very poor" and 7 with "Very good." Higher numbers indicate better outcome.
Up to 9 months
Secondary Aim 2: Alertness - eDiary
大体时间:1 week of daily eDiary in both Month 1 and Month 3
Alertness will be self-reported via 100 mm visual analog scales anchored with "Sleepy" at 0 and "Alert" at 100. Higher scores indicate a better outcome.
1 week of daily eDiary in both Month 1 and Month 3
Secondary Aim 2: Energy - Monthly questionnaire
大体时间:Up to 9 months
Energy will be self-reported via a 7-point Likert scale anchored at 0 with "Very low" and 7 with "Very high." Higher numbers indicate better outcome.
Up to 9 months
Secondary Aim 2: Energy - eDiary
大体时间:1 week of daily eDiary in both Month 1 and Month 3
Energy will be self-reported via 100 mm visual analog scales anchored with "Sluggish" at 0 and "Energetic" at 100. Higher scores indicate a better outcome.
1 week of daily eDiary in both Month 1 and Month 3
Secondary Aim 3: Adverse Health and Safety Outcomes - Motor Vehicle Crashes
大体时间:Up to 9 months
Motor vehicle crashes will be self-reported on the monthly questionnaires (count per month).
Up to 9 months
Secondary Aim 3: Adverse Health and Safety Outcomes - Near Crash Incidents
大体时间:Up to 9 months
Near crash incidents will be self-reported on the monthly questionnaires (count per month).
Up to 9 months
Secondary Aim 3: Adverse Health and Safety Outcomes - Injuries
大体时间:Up to 9 months
Injuries will be self-reported on the monthly questionnaires (count per month).
Up to 9 months
Secondary Aim 3: Adverse Health and Safety Outcomes - Attentional Failures
大体时间:Up to 9 months
Attentional failures (nodding off) will be self-reported on the monthly questionnaires (count per month).
Up to 9 months
Secondary Aim 4: Health Care Costs
大体时间:Up to 9 months
Healthcare utilization will be reported on monthly surveys and costs estimated from the reported usages.
Up to 9 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

  • 研究主任:Rebecca Robbins, PhD、Brigham and Women's Hospital / Harvard Medical School

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2020年8月12日

初级完成 (实际的)

2021年5月27日

研究完成 (实际的)

2021年9月30日

研究注册日期

首次提交

2019年12月23日

首先提交符合 QC 标准的

2020年1月8日

首次发布 (实际的)

2020年1月13日

研究记录更新

最后更新发布 (实际的)

2022年6月22日

上次提交的符合 QC 标准的更新

2022年6月16日

最后验证

2022年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Anonymized study data will be made available upon request, consistent with our institution's IRB policies and procedures. Data and supporting documentation will become available two years following the primary publication and remain available for five years. Interested individuals will be asked to provide a research plan. Requests will be reviewed and granted as appropriate.

IPD 共享时间框架

Data will become available two years following the primary publication. It will be available for 5 years.

IPD 共享访问标准

Consistent with MGB IRB policies and procedures.

IPD 共享支持信息类型

  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

Dayzz app的临床试验

3
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