Clinical trial NCT03808246: Detection of Usability Errors of a Medical Device Zeneo®
Official title: Detection of Usability Errors of a Medical Device Zeneo®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2019-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 profiles of participants (naïves vs. informed) x 2 types of test environment (realistic vs. laboratory-like).

Each participant, depending on her/his profile is assigned to one "profile of participant" group and randomly to one "type of test environment" group.
Primary purpose: OTHER

Brief 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.

Eligibility 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.

Primary outcomes:
measure: For each arm, number of participants needed to uncover 95% of the use errors known
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: number of use errors uncovered per participant
timeFrame: through study completion, an average of 6 months
measure: number of participants who detected a given error
timeFrame: through study completion, an average of 6 months
measure: number of unanticipated errors detected
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Usability Lab of CIC IT 1403
state: Haut De France
Study officials:
affiliation: University Hospital, Lille
name: Romaric Marcilly, PhD
role: PRINCIPAL_INVESTIGATOR
References: