- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04224285
Operational Trial of Dayzz App
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Partners HealthCare
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Primary Aim 1: Sleep Behavior 1
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Secondary Aim 1: Absenteeism
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Rebecca Robbins, PhD, Brigham and Women's Hospital / Harvard Medical School
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2019P003277
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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