Operational Trial of Dayzz App
研究概览
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Partners HealthCare
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
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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.
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Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution
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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.
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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 |
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Primary Aim 1: Sleep Behavior 1
大体时间:Up to 9 months
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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.
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Up to 9 months
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Primary Aim 1: Sleep Behavior 2
大体时间:1 week of daily eDiary in both Month 1 and Month 3
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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).
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1 week of daily eDiary in both Month 1 and Month 3
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Primary Aim 1: Sleep Behavior 3
大体时间:Up to 9 months
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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.
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Up to 9 months
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Primary Aim 2: Sleep Duration
大体时间:1 week of daily eDiary in both Month 1 and Month 3
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Sleep duration will be reported in the eDiary.
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1 week of daily eDiary in both Month 1 and Month 3
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Primary Aim 2: Sleep Quality
大体时间:Up to 9 months
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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).
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Up to 9 months
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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
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Unscheduled absences and disability day usage will be collected by self-report on the monthly questionnaires.
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Up to 9 months
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Secondary Aim 1: Performance/Productivity - Absenteeism
大体时间:Up to 9 months
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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.
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Up to 9 months
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Secondary Aim 1: Performance/Productivity - Presenteeism
大体时间:Up to 9 months
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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.
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Up to 9 months
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Secondary Aim 2: Mood - Monthly questionnaire
大体时间:Up to 9 months
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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.
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Up to 9 months
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Secondary Aim 2: Mood - eDiary
大体时间:1 week of daily eDiary in both Month 1 and Month 3
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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.
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1 week of daily eDiary in both Month 1 and Month 3
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Secondary Aim 2: Alertness - Monthly questionnaire
大体时间:Up to 9 months
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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.
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Up to 9 months
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Secondary Aim 2: Alertness - eDiary
大体时间:1 week of daily eDiary in both Month 1 and Month 3
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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.
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1 week of daily eDiary in both Month 1 and Month 3
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Secondary Aim 2: Energy - Monthly questionnaire
大体时间:Up to 9 months
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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.
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Up to 9 months
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Secondary Aim 2: Energy - eDiary
大体时间:1 week of daily eDiary in both Month 1 and Month 3
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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.
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1 week of daily eDiary in both Month 1 and Month 3
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Secondary Aim 3: Adverse Health and Safety Outcomes - Motor Vehicle Crashes
大体时间:Up to 9 months
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Motor vehicle crashes will be self-reported on the monthly questionnaires (count per month).
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Up to 9 months
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Secondary Aim 3: Adverse Health and Safety Outcomes - Near Crash Incidents
大体时间:Up to 9 months
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Near crash incidents will be self-reported on the monthly questionnaires (count per month).
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Up to 9 months
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Secondary Aim 3: Adverse Health and Safety Outcomes - Injuries
大体时间:Up to 9 months
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Injuries will be self-reported on the monthly questionnaires (count per month).
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Up to 9 months
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Secondary Aim 3: Adverse Health and Safety Outcomes - Attentional Failures
大体时间:Up to 9 months
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Attentional failures (nodding off) will be self-reported on the monthly questionnaires (count per month).
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Up to 9 months
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Secondary Aim 4: Health Care Costs
大体时间:Up to 9 months
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Healthcare utilization will be reported on monthly surveys and costs estimated from the reported usages.
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Up to 9 months
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合作者和调查者
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
一般刊物
- Robbins R, Weaver MD, Quan SF, Sullivan JP, Qadri S, Glasner L, Cohen-Zion M, Czeisler CA, Barger LK. Evaluating the impact of a sleep health education and a personalised smartphone application on sleep, productivity and healthcare utilisation among employees: results of a randomised clinical trial. BMJ Open. 2022 Sep 14;12(9):e062121. doi: 10.1136/bmjopen-2022-062121.
- Robbins R, Weaver MD, Quan SF, Sullivan JP, Cohen-Zion M, Glasner L, Qadri S, Czeisler CA, Barger LK. A clinical trial to evaluate the dayzz smartphone app on employee sleep, health, and productivity at a large US employer. PLoS One. 2022 Jan 5;17(1):e0260828. doi: 10.1371/journal.pone.0260828. eCollection 2022.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2019P003277
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
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
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