Detection of Usability Errors of a Medical Device Zeneo®

NCT03808246 | Completed

• 2 other identifiers: 2017_162017-A02847-46
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

  through study completion, an average of 6 months

Secondary Outcomes (3)

• number of use errors uncovered per participant

  through study completion, an average of 6 months

• number of participants who detected a given error

  through study completion, an average of 6 months

• number of unanticipated errors detected

  through study completion, an average of 6 months

Study Arms (4)

naive/realistic environment

EXPERIMENTAL

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".

Other: using the demo version of a self-injector pen

informed/realistic environment

EXPERIMENTAL

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".

Other: using the demo version of a self-injector pen

informed/laboratory-like environment

EXPERIMENTAL

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".

Other: using the demo version of a self-injector pen

naive/laboratory-like environment

EXPERIMENTAL

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".

Other: using the demo version of a self-injector pen

Interventions

using the demo version of a self-injector pen 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; informed/realistic environment; naive/laboratory-like environment; naive/realistic environment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• Pregnant women
• Vulnerable Persons
• Persons under administrative supervision
• Persons who are subject to a judicial protection measure
• Persons who do not understand correctly French.

Sponsors & Collaborators

• University Hospital, Lille: lead
• National Research Agency, France: collaborator

Study Sites (1)

Usability Lab of CIC IT 1403

Lille, Haut de France, 59037, France

Location

Related Publications (1)

• Caron A, Vandewalle V, Marcilly R, Rochat J, Dervaux B. The Optimal Sample Size for Usability Testing, From the Manufacturer's Perspective: A Value-of-Information Approach. Value Health. 2022 Jan;25(1):116-124. doi: 10.1016/j.jval.2021.07.010. Epub 2021 Aug 28.

  PMID: 35031090 RESULT

Study Officials

• Romaric Marcilly, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: January 17, 2019
• Study Start: April 24, 2019
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: April 22, 2026

Record last verified: 2020-03

Locations

FR (1)