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

Completed

• Conditions: Peritoneal Dialysis

• Registration Number: NCT07131995
• Lead Sponsor: UMC Utrecht

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.

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Study First Submitted: 2025-07-15
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-17
• Last Update Submitted: 2025-08-17
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Use errors	Procedure (usability test)	The number and percentages of incorrect actions during task performance. Reported per participant and for the total group.

Secondary Outcome Measures

Name	Time	Method
Perceived usability	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.
Completion rate	Procedure (usability test)	The number and percentages of tasks successfully completed during task performance. Reported per participant and for the total group.

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands