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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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

1355

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
        • Partners HealthCare

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：ヘルスサービス研究
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：Dayzz app
Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution
介入なし：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Primary Aim 1: Sleep Behavior 1
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Secondary Aim 1: Absenteeism
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 9 months
Healthcare utilization will be reported on monthly surveys and costs estimated from the reported usages.
Up to 9 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Brigham and Women's Hospital

捜査官

  • スタディディレクター：Rebecca Robbins, PhD、Brigham and Women's Hospital / Harvard Medical School

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年8月12日

一次修了 (実際)

2021年5月27日

研究の完了 (実際)

2021年9月30日

試験登録日

最初に提出

2019年12月23日

QC基準を満たした最初の提出物

2020年1月8日

最初の投稿 (実際)

2020年1月13日

学習記録の更新

投稿された最後の更新 (実際)

2022年6月22日

QC基準を満たした最後の更新が送信されました

2022年6月16日

最終確認日

2022年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2019P003277

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

Consistent with MGB IRB policies and procedures.

IPD 共有サポート情報タイプ

  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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