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OpenTrials
Completed

NCT Number: NCT07131995

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

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Nurses: none.
  • Patients: severe physical and/or cognitive impairment, as judged by the researchers.

Treatment and study plan

Primary outcomes

  1. Use errors

    Time frame: During the procedure (usability test)

    The number and percentages of incorrect actions during task performance. Reported per participant and for the total group.

Secondary outcomes

  1. Completion rate

    Time frame: During the procedure (usability test)

    The number and percentages of tasks successfully completed during task performance. Reported per participant and for the total group.

  2. Perceived usability

    Time frame: Immediately after the procedure (usability test)

    Participants' perceived usability of the device using the 10-item System Usability Scale (0-100 scale). Scores were reported per participant and for the total group.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Azienda Unita' Sanitaria Locale Di Modena
  • Hospital Universitario La Paz

Registry information

Acronym: WEAKID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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