Formative Usability Testing Study of a Novel Medical Device for Peritoneal Dialysis (WEAKID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Use errors
研究概览
简要总结
This study aimed to formatively test the usability of the WEarable Artificial KIDney (WEAKID) for peritoneal dialysis (PD) in the device's intended user populations (i.e., nurses and patients).
详细描述
End stage renal disease is a growing health problem worldwide, with a growing number of patients requiring a kidney transplantation. Recent years have seen the development of multiple novel devices for both hemodialysis and peritoneal dialysis (PD), one of these devices being the WEarable Artificial KIDney (WEAKID) for PD. WEAKID uses both sorbent technology and continuous flow PD to improve dialysis efficacy. Here, we present the results of a formative usability testing study of WEAKID among nurses and patients. We included 14 participants (n=6 nurses, n=8 patients) in three participating centres (Modena University Hospital, Italy; La Paz University Hospital Madrid, Spain; University Medical Center Utrecht, the Netherlands). Participants were asked to perform basic operational procedures with the device according to a usability task list. Their performance was observed and use errors were noted. Furthermore, participants were asked for feedback, both verbally and by means of completing the system usability scale (SUS), reflecting perceived usability on a scale from 0 (worst) to 100 (best). In total, 22 use errors occurred, 10 in nurses and 12 in patients. The mean SUS score was 70 (range 57.5 - 85) for nurses, and 71.9 (range 55 - 87.5) for patients. Despite the slightly above-average perceived usability of the device's current design stage, participants made a lot of suggestions for improvements, and indeed, usability must be improved to make the device ready for market introduction.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Nurses: aged 18 years or older, >1 years of professional experience with PD.
- •Patients: aged 18 years or older, clinical diagnosis of ESRD, any treatment experience with PD, either current or in the past.
排除标准
- •Nurses: none.
- •Patients: severe physical and/or cognitive impairment, as judged by the researchers.
结局指标
主要结局
Use errors
时间窗: During the procedure (usability test)
The number and percentages of incorrect actions during task performance. Reported per participant and for the total group.
次要结局
- Completion rate(During the procedure (usability test))
- Perceived usability(Immediately after the procedure (usability test))
研究者
Karin G.F. Gerritsen
Principal Investigator
UMC Utrecht
