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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07131995
Acronym
WEAKID
Enrollment
14
Registered
2025-08-20
Start date
2021-11-01
Completion date
2022-12-01
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis

Brief summary

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).

Detailed description

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.

Interventions

None listed

Sponsors

Hospital Universitario La Paz
CollaboratorOTHER
Azienda Unita' Sanitaria Locale Di Modena
CollaboratorOTHER
UMC Utrecht
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Use errorsDuring the procedure (usability test)The number and percentages of incorrect actions during task performance. Reported per participant and for the total group.

Secondary

MeasureTime frameDescription
Completion rateDuring the procedure (usability test)The number and percentages of tasks successfully completed during task performance. Reported per participant and for the total group.
Perceived usabilityImmediately 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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026