Distracted Driving App Study for Teens and Parents/Caregivers (IDD)
11 de noviembre de 2021 actualizado por: Children's Hospital of Philadelphia
An Informatics Approach to Preventing Distracted Driving
The purpose of this research study is to determine if a new smartphone application helps to decrease distracted driving, and to learn about parent and teen perspectives about the application
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This 3-group randomized controlled trial aims to (1) evaluate the frequency of smartphone use among young drivers and their parents/caregivers while driving; and (2) determine if the LifeSaver mobile app reduces the rate of smartphone use while driving.
Eligible participants will be licensed teenage drivers between the ages of 16 and 18 years, and a parent/caregiver.
The app will be downloaded and installed on both parent/caregivers' and teens' phones to monitor phone use while in a vehicle for 8 weeks.
Tipo de estudio
Intervencionista
Inscripción (Actual)
134
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19146
- Children's Hospital of Philadelphia Roberts Center for Pediatric Research
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
16 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Licensed teen drivers 16 years to 18 years and one parent/caregiver
- Teen and parent/caregiver are both Android smartphone users
- Teen and parent/caregiver both drive a minimum of 2 days per week
Exclusion Criteria:
- Non-fluency in written or spoken English
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm 1
Participants alternate between using the Manual Mode of the app for 2 weeks and Auto-Detect Mode of the app for 2 weeks, for a total of 4 periods (8 weeks).
|
In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.
Otros nombres:
In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.
Otros nombres:
|
|
Experimental: Arm 2
Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks.
|
In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.
Otros nombres:
In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.
Otros nombres:
|
|
Experimental: Arm 3
Participants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks.
|
In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.
Otros nombres:
The LifeSaver app tracks the date, time, and global positioning system (GPS) location of each trip that the participant takes in a moving vehicle, along with a list of apps used during the trip, but does not contain any anti-distracted driving features.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in frequency of smartphone use while driving
Periodo de tiempo: Week 2, 4, 6, and post-intervention at Week 8
|
Frequency of smartphone use is recorded by the LifeSaver app among the three app modes.
Within-driver smartphone use over the 8-week study period is compared as the app modes change.
|
Week 2, 4, 6, and post-intervention at Week 8
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in frequency of self-reported smartphone use while driving
Periodo de tiempo: Weeks 2, 4, 6, and Post-Intervention at Week 8
|
The change in self-reported smartphone use while driving will be assessed using the same within-driver and between-driver comparisons as the primary outcome measure.
Self-reported smartphone use is collected through 10 items on a participant survey that is completed at enrollment, Weeks 2, 4, 6 and post-intervention at Week 8. Participants report how many days during the previous 2 weeks (0-14) that they drove, and talked on a hands-held smartphone, talked on a hands-free smartphone, sent a text, and read a text while driving.
Participants also report how many times per day (free text, any number greater than or equal to 0) that they drove, and talked on a hands-held smartphone, talked on a hands-free smartphone, sent a text, and read a text while driving.
There is no overall self-reported smartphone use score for these survey items.
|
Weeks 2, 4, 6, and Post-Intervention at Week 8
|
|
Participant acceptability of the smartphone App: survey
Periodo de tiempo: Post-Intervention at Week 8
|
Participant assessment of accessibility will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared.
Participants complete a survey at Week 8, post-intervention.
8 items in the survey ask participants about accessibility of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about accessibility of the app through open-ended questions, where participants are able to enter free text.
There is no overall score for these survey items.
|
Post-Intervention at Week 8
|
|
Participant usability of the smartphone app: survey
Periodo de tiempo: Post-Intervention at Week 8
|
Participant assessment of usability will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared.
Participants complete a survey at Week 8, post-intervention.
8 items in the survey ask participants about usability of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about usability of the app through open-ended questions, where participants are able to enter free text.
There is no overall score for these survey items.
|
Post-Intervention at Week 8
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sara Seifert, MPH, Minnesota HealthSolutions
- Investigador principal: Allison Curry, PhD, MPH, Children's Hospital of Philadelphia
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de enero de 2020
Finalización primaria (Actual)
31 de agosto de 2021
Finalización del estudio (Actual)
31 de agosto de 2021
Fechas de registro del estudio
Enviado por primera vez
22 de noviembre de 2019
Primero enviado que cumplió con los criterios de control de calidad
25 de noviembre de 2019
Publicado por primera vez (Actual)
26 de noviembre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de noviembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
11 de noviembre de 2021
Última verificación
1 de noviembre de 2021
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 19-016717
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Data and study documents will be shared with Minnesota HealthSolutions (the sponsor).
No identifiable data will be used for future studies without first obtaining CHOP Institutional Review Board (IRB) approval.
The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).
Marco de tiempo para compartir IPD
The study will comply with CHOP's data retention policy.
All study data will be maintained for at least 6 years following study completion.
There is no set timeline for the destruction of the study's de-identified data.
Criterios de acceso compartido de IPD
IRB approval, data use agreement
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
Ensayos clínicos sobre Manual Mode
-
Josue Fernandez CarneroUniversidad Autonoma de MadridTerminadoCervicalgia | Dolores de cuello | Dolores cervicales posteriores | Dolor de cuello posterior
-
Universidad de ZaragozaTerminadoPlagiocefalia | Plagiocefalia No Sinostótica | Plagiocefalia PosicionalEspaña
-
University of ArizonaNational Cancer Institute (NCI)TerminadoCáncerEstados Unidos
-
Alexander AchalandabasoTerminadoDolor crónico | Dolor de cuelloEspaña
-
Universidad de ZaragozaTerminadoDientes tratados con endodoncia | Terapia de conducto radicularEspaña
-
Imam Abdulrahman Bin Faisal UniversityDesconocido
-
William Beaumont HospitalsTerminadoEl embarazo | Parto por cesáreaEstados Unidos
-
University of AlcalaTerminado
-
Universitat de LleidaReclutamientoFibromialgia | Trastorno TemporomandibularEspaña
-
Hacettepe UniversityTerminado