- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02345941
Safety in Seconds 2.0: An App to Increase Car Seat Use
Evaluating a Web-based Child Passenger Safety Program: Safety in Seconds 2.0
This project will utilize the first web-based program to provide tailored injury prevention education. The existing Safety in Seconds program was adapted into a smartphone platform. Parents are recruited from and engage in the program in the clinical setting (PED or PTS). Parents download the app onto their smartphone which is used to ask the questions, collect a parent's responses, assess the parents' safety needs and give tailored directions for proper car sear use. The control group parents will also engage with the smartphone app and receive immediate feedback. However, they will receive tailored educational messages about smoke alarms. Parents will also have access to the online SIS v 2.0 Parent Portal which will have educational features (e.g., tips for keeping children content in their CSSs, links to helpful websites). The investigators will use emerging technology such as push notification and email to remind parents to visit the portal and have their child's car seat reassessed.
The investigators plan to conduct a cost benefit analysis of the program's expected financial benefit from the perspective of a third party payer of medical claims and an in-depth examination of program adoption and implementation using qualitative data collected from key informant interviews, direct observations of the clinic environments, and document review.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
-
-
Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins School of Public Health
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Visiting the Pediatric Emergency Department (PED) at Johns Hopkins Hospital or Arkansas Children's Hospital
- Parent or guardian of child 4-7 years
- English speaking
- Have and Android or iPhone smartphone
- Drive with the child in a car at least once per week in a car that the parent owns, borrows or gets a ride round-trip
- Resident of Baltimore City, MD or Little Rock, AR and surrounding area.
Exclusion Criteria:
- PED has flagged case as suspected abuse
- Another household member is enrolled in the study
- In Arkansas, less than 18 years without parent present at the PED
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Invervention
The intervention group will get tailored information on the Parent Action Report and the Parent Portal about child safety seats and booster seats.
|
Parent Action Report will be displayed after the baseline assessment and contain educational safety messages.
Parents will have access to the Parent Portal, and they will be encouraged to visit it at any time.
|
Comparador activo: Control
The control group will get tailored information in the Parent Action Report and the Parent Portal about smoke alarms.
|
Parent Action Report will be displayed after the baseline assessment and contain educational safety messages.
Parents will have access to the Parent Portal, and they will be encouraged to visit it at any time.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline self-reported car seat use at 6 months
Periodo de tiempo: 6 months
|
Self-reported measures include the type of car seat used (rear-facing car seat, forward-facing car seat, booster seat, or seat belt), the location in car where it is used (front seat or backseat), frequency of use (some of the time or all of the time) and having the seat inspected by a car seat technician.
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6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline self-reported smoke alarm use at 6 months
Periodo de tiempo: 6 months
|
Self-reported measures include having a smoke alarm on every level of the home, having long-life battery alarms in the home, having a fire escape plan and practicing the fire escape plan.
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6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Elise C Omaki, MHS, Johns Hopkins Bloomberg School of Public Health
Publicaciones y enlaces útiles
Publicaciones Generales
- Gielen AC, Bishai DM, Omaki E, Shields WC, McDonald EM, Rizzutti NC, Case J, Stevens MW, Aitken ME. Results of an RCT in Two Pediatric Emergency Departments to Evaluate the Efficacy of an m-Health Educational App on Car Seat Use. Am J Prev Med. 2018 Jun;54(6):746-755. doi: 10.1016/j.amepre.2018.01.042. Epub 2018 Apr 12.
- Omaki E, Shields WC, McDonald E, Aitken ME, Bishai D, Case J, Gielen A. Evaluating a smartphone application to improve child passenger safety and fire safety knowledge and behaviour. Inj Prev. 2017 Feb;23(1):58. doi: 10.1136/injuryprev-2016-042161. Epub 2016 Sep 5.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HD069221-01A1
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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