Detection of Usability Errors of a Medical Device Zeneo®
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In order to determine how many participants must be recruited to detect 95% of the anticipated use errors, two groups of participants (naives or informed to the type of device under evaluation) will take part to usability test of a demo version of an auto injector pen in one of two test environments (realistic or laboratory-like). The combination of the 2 types of users and the two types of environment composes 4 arms.
By default, 15 participants will be recruited per arm (in conformity with usual guidelines). If, in a given group, 95% of anticipated errors are detected, no more participants will be recruited in the arm. Otherwise, 5 other participants will be recruited till the 95% threshold is reached with a maximum of 40 participants per group.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Haut De France
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Lille, Haut De France, Francia, 59037
- Usability Lab of CIC IT 1403
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Two types of participants (healthy people) will be recruited: participants informed about auto-injector pens (BUT NOT PATIENTS) and participants naïves on this topic.
Inclusion Criteria:
- Able to use the device
- Without previous experience of anaphylactic shock
- Not taking a psychotropic drug
- Without hearing impairment
- Covered by social security
- Who signed the consent form and the information letter
- Who agree to conform to the procedure of the study -
Exclusion Criteria:
- Pregnant women
- Vulnerable Persons
- Persons under administrative supervision
- Persons who are subject to a judicial protection measure
- Persons who do not understand correctly French.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: naive/realistic environment
This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
|
|
Experimental: informed/realistic environment
This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
|
|
Experimental: informed/laboratory-like environment
This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
|
|
Experimental: naive/laboratory-like environment
This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
For each arm, number of participants needed to uncover 95% of the use errors known
Periodo de tiempo: through study completion, an average of 6 months
|
through study completion, an average of 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
number of use errors uncovered per participant
Periodo de tiempo: through study completion, an average of 6 months
|
through study completion, an average of 6 months
|
|
number of participants who detected a given error
Periodo de tiempo: through study completion, an average of 6 months
|
through study completion, an average of 6 months
|
|
number of unanticipated errors detected
Periodo de tiempo: through study completion, an average of 6 months
|
through study completion, an average of 6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Romaric Marcilly, PhD, University Hospital, Lille
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
Otros números de identificación del estudio
- 2017_16
- 2017-A02847-46 (Otro identificador: ID-RCB number, ANSM)
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.
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