Detection of Usability Errors of a Medical Device Zeneo®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- For each arm, number of participants needed to uncover 95% of the use errors known
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 -
排除标准
- •Pregnant women
- •Vulnerable Persons
- •Persons under administrative supervision
- •Persons who are subject to a judicial protection measure
- •Persons who do not understand correctly French.
研究组 & 干预措施
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".
干预措施: using the demo version of a self-injector pen (Other)
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".
干预措施: using the demo version of a self-injector pen (Other)
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".
干预措施: using the demo version of a self-injector pen (Other)
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".
干预措施: using the demo version of a self-injector pen (Other)
结局指标
主要结局
For each arm, number of participants needed to uncover 95% of the use errors known
时间窗: through study completion, an average of 6 months
次要结局
- 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)