Detection of Usability Errors of a Medical Device Zeneo®
- Conditions
- Healthy Volunteers
- Interventions
- Other: using the demo version of a self-injector pen
- Registration Number
- NCT03808246
- Lead Sponsor
- University Hospital, Lille
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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 -
- Pregnant women
- Vulnerable Persons
- Persons under administrative supervision
- Persons who are subject to a judicial protection measure
- Persons who do not understand correctly French.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description informed/realistic environment using the demo version of a self-injector pen 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". naive/realistic environment using the demo version of a self-injector pen 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". informed/laboratory-like environment using the demo version of a self-injector pen 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". naive/laboratory-like environment using the demo version of a self-injector pen 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".
- Primary Outcome Measures
Name Time Method For each arm, number of participants needed to uncover 95% of the use errors known through study completion, an average of 6 months
- Secondary Outcome Measures
Name Time Method number of use errors uncovered per participant through study completion, an average of 6 months number of unanticipated errors detected through study completion, an average of 6 months number of participants who detected a given error through study completion, an average of 6 months
Trial Locations
- Locations (1)
Usability Lab of CIC IT 1403
🇫🇷Lille, Haut De France, France