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

NCT07131995 | Completed

• 1 other identifier: 21/616
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• Use errors

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

  During the procedure (usability test)

Secondary Outcomes (2)

• Completion rate

  During the procedure (usability test)

• Perceived usability

  Immediately after the procedure (usability test)

Study Arms (2)

Nurses

Nurses, aged 18 years or older, and having \>1 years of professional experience with PD.

Patients

Patients, aged 18 years or older, having a clinical diagnosis of ESRD and any treatment experience with PD, either current or in the past.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants represented two populations of intended users of the device, namely nurses and patients. The sample sizes were set at 6 (nurses) and 8 (patients). Prior work on the sample sizes of formative usability testing has shown that these sample sizes suffice to identify the most important design issues.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• UMC Utrecht: lead
• Hospital Universitario La Paz: collaborator
• Azienda Unita' Sanitaria Locale Di Modena: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 20, 2025
• Study Start: November 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)