Detection of Usability Errors of a Medical Device Zeneo®

University Hospital, Lille

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: using the demo version of a self-injector pen

Study type: Interventional

Funder types: Other

Identifiers

NCT03808246

2017_16

2017-A02847-46 (Other Identifier)

Details and patient eligibility

About

The research addresses the question of the number of participants needed to identify as many usability-induced errors as possible in the context of summative usability tests. The research addresses also the impact of the ecological validity of the test environment on the number of usability-induced errors uncovered.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 4 patient groups

naive/realistic environment

Experimental group

Description:

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".

Treatment:

Other: using the demo version of a self-injector pen

informed/realistic environment

Experimental group

Description:

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".

Treatment:

Other: using the demo version of a self-injector pen

informed/laboratory-like environment

Experimental group

Description:

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".

Treatment:

Other: using the demo version of a self-injector pen

naive/laboratory-like environment

Experimental group

Description:

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".

Treatment:

Other: using the demo version of a self-injector pen