CompletedNot Applicable

Detection of Usability Errors of a Medical Device Zeneo®

France60 participantsStarted 2019-04-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

For each arm, number of participants needed to uncover 95% of the use errors known

Timeframe: through study completion, an average of 6 months

Trial details

NCT IDNCT03808246

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-09

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