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临床试验/NCT07131995
NCT07131995已完成不适用

Formative Usability Testing Study of a Novel Medical Device for Peritoneal Dialysis (WEAKID)

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年11月1日最近更新:

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

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

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karin G.F. Gerritsen

Principal Investigator

UMC Utrecht

研究点 (1)

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