Detection of Usability Errors of a Medical Device Zeneo®

Sponsor
University Hospital, Lille (Other)
Overall Status
Completed
CT.gov ID
NCT03808246
Collaborator
National Research Agency, France (Other)
60
1
4
7.5
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: using the demo version of a self-injector pen
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Detection of Usability Errors of a Medical Device Zeneo®
Actual Study Start Date :
Apr 24, 2019
Actual Primary Completion Date :
Dec 9, 2019
Actual Study Completion Date :
Dec 9, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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".

Other: 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.

Experimental: 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".

Other: 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.

Experimental: 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".

Other: 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.

Experimental: 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".

Other: 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.

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. number of use errors uncovered per participant [through study completion, an average of 6 months]

  2. number of participants who detected a given error [through study completion, an average of 6 months]

  3. number of unanticipated errors detected [through study completion, an average of 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Usability Lab of CIC IT 1403 Lille Haut De France France 59037

Sponsors and Collaborators

  • University Hospital, Lille
  • National Research Agency, France

Investigators

  • Principal Investigator: Romaric Marcilly, PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT03808246
Other Study ID Numbers:
  • 2017_16
  • 2017-A02847-46
First Posted:
Jan 17, 2019
Last Update Posted:
Mar 26, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 26, 2020