Operational Trial of Dayzz App
16 de junho de 2022 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
1355
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02115
- Partners HealthCare
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Primary Aim 1: Sleep Behavior 1
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Secondary Aim 1: Absenteeism
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to 9 months
|
Healthcare utilization will be reported on monthly surveys and costs estimated from the reported usages.
|
Up to 9 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Rebecca Robbins, PhD, Brigham and Women's Hospital / Harvard Medical School
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
12 de agosto de 2020
Conclusão Primária (Real)
27 de maio de 2021
Conclusão do estudo (Real)
30 de setembro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
23 de dezembro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de janeiro de 2020
Primeira postagem (Real)
13 de janeiro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de junho de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de junho de 2022
Última verificação
1 de junho de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2019P003277
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Data will become available two years following the primary publication.
It will be available for 5 years.
Critérios de acesso de compartilhamento IPD
Consistent with MGB IRB policies and procedures.
Tipo de informação de suporte de compartilhamento de IPD
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .