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Operational Trial of Dayzz App

16 juin 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

1355

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02115
        • Partners HealthCare

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: Dayzz app
Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Primary Aim 1: Sleep Behavior 1
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Secondary Aim 1: Absenteeism
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Up to 9 months
Healthcare utilization will be reported on monthly surveys and costs estimated from the reported usages.
Up to 9 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Brigham and Women's Hospital

Les enquêteurs

  • Directeur d'études: Rebecca Robbins, PhD, Brigham and Women's Hospital / Harvard Medical School

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 août 2020

Achèvement primaire (Réel)

27 mai 2021

Achèvement de l'étude (Réel)

30 septembre 2021

Dates d'inscription aux études

Première soumission

23 décembre 2019

Première soumission répondant aux critères de contrôle qualité

8 janvier 2020

Première publication (Réel)

13 janvier 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juin 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 juin 2022

Dernière vérification

1 juin 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2019P003277

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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

Critères d'accès au partage IPD

Consistent with MGB IRB policies and procedures.

Type d'informations de prise en charge du partage d'IPD

  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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