NCT06369740

Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia a Monitoring

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Enzyre B.V. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This observational study consists of two parts. In part one, case scenario focus groups with hemophilia A patients and healthcare providers (HCPs) will be held. This parts aims to identify potential use scenarios of a point of care (POC) in vitro medical for patients with hemophilia A. The main questions it aims to answer are: * How is coagulation lab testing for patients with hemophilia A currently organized? * What is the interest and what are desired alternatives of a POC in-vitro diagnostic medical device for patients with hemophilia A? Part two of the study consists of a use scenario study in which patients with hemophilia A and HCPs will evaluate two types of non-functional mock-ups of a POC in vitro medical device. The main goal of this part is to evaluate the usability of the current prototypes of the POC device.

Conditions

• Hemophilia a

Interventions

Type	Name	Description
OTHER	Case scenarios - questionnaire	Participants fill in a questionnaire on the current care of hemophilia A and envisioned use scenarios of a point-of-care diagnostic device for hemophilia A.
OTHER	Case scenarios - Focus groups	Participants partake in focus groups on the current care for hemophilia A, the envisioned use scenarios of point-of-care diagnostic device for hemophilia A and desired features of such a diagnostic device.
OTHER	Use scenarios - Usability test	Participants are asked to perform basic tasks with the mock-ups with minimal instructions, they will also be given a graphic of the user interface (GUI).
OTHER	Use scenarios - interview	The participants will be interviewed and asked for their opinions and experiences with the mock-ups.

Timeline

• Start date: 2024-08-22
• Primary completion: 2024-08-25
• Completion: 2024-08-25
• First posted: 2024-04-17
• Last updated: 2024-10-29

Locations

1 site across 1 country: United States