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Operational Trial of Dayzz App

16. juni 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

1355

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Partners HealthCare

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Dayzz app
Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Aim 1: Sleep Behavior 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Secondary Aim 1: Absenteeism
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 9 months
Healthcare utilization will be reported on monthly surveys and costs estimated from the reported usages.
Up to 9 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Brigham and Women's Hospital

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. august 2020

Primær fullføring (Faktiske)

27. mai 2021

Studiet fullført (Faktiske)

30. september 2021

Datoer for studieregistrering

Først innsendt

23. desember 2019

Først innsendt som oppfylte QC-kriteriene

8. januar 2020

Først lagt ut (Faktiske)

13. januar 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2019P003277

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

Tilgangskriterier for IPD-deling

Consistent with MGB IRB policies and procedures.

IPD-deling Støtteinformasjonstype

  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Medisinsk tilstand

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Forhold

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