NCT03808246

Detection of Usability Errors of a Medical Device Zeneo®

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2019-04-24
• Primary completion: 2019-12-09
• Completion: 2019-12-09
• First posted: 2019-01-17
• Last updated: 2020-03-26

Locations

1 site across 1 country: France