Detection of Usability Errors of a Medical Device Zeneo®

NCT ID: NCT03808246

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-24
• Study Completion Date: 2019-12-09

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

naive/realistic environment

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".

Group Type: EXPERIMENTAL

using the demo version of a self-injector pen

Intervention Type: OTHER

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.

informed/realistic environment

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".

Group Type: EXPERIMENTAL

using the demo version of a self-injector pen

Intervention Type: OTHER

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.

informed/laboratory-like environment

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".

Group Type: EXPERIMENTAL

using the demo version of a self-injector pen

Intervention Type: OTHER

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.

naive/laboratory-like environment

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".

Group Type: EXPERIMENTAL

using the demo version of a self-injector pen

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Agency, France

OTHER

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romaric Marcilly, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Usability Lab of CIC IT 1403

Lille, Haut de France, France

Countries

France

Other Identifiers

2017-A02847-46

Identifier Type: OTHER

Identifier Source: secondary_id

2017_16

Identifier Type: -

Identifier Source: org_study_id