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

Completed

• Conditions: Hemophilia a

• Registration Number: NCT06369740
• Lead Sponsor: Enzyre B.V.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Study Start: 2024-08-22
• Primary Completion: 2024-08-25
• Study Completion: 2024-08-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Patients:

• With Hemophilia A diagnosis
• All Hemophilia A severity categories are eligible (mild, moderate, or severe)
• Aged 12 years and older
• For children aged 12 through 17 their parent must provide permission by signing the informed consent form
• Consider English their primary language (capable of communicating in English verbally and in writing)
• Capable of giving informed consent or assent

Family member(s) of patients:

• Related to a patient with Hemophilia A (mild, moderate, or severe)
• Aged 18 years and older
• Consider English their primary language (capable of communicating in English verbally and in writing)
• Capable of giving informed consent or assent

Healthcare professionals:

• Healthcare workers specialized in hemophilia care. (e.g. hematologists, nurse practitioners, physician assistants, nurses, and pharmacists)
• Capable of giving informed consent

Exclusion Criteria

Patients:

• Without a diagnosis of Hemophilia A
• With acquired Hemophilia A
• Younger than 12 years of age
• Unable to communicate in English
• Incapable of giving consent or assent for themselves

Specifically for the case scenario focus group

• Unwilling to consent to voice recording
• Participating in the use scenario part of the study

Specifically for the use scenario part of the study

• Unwilling to consent to video recording
• Participating in the case scenario part of the study

Family members:

• No relation to a patient with Hemophilia A (mild, moderate, or severe)
• Related to a patient with acquired Hemophilia A
• Younger than 18 years of age
• Unable to communicate in English
• Incapable of giving consent or assent for themselves

Specifically for the case scenario focus group

• Unwilling to consent to voice recording
• Participating in the use scenario part of the study

Specifically for the use scenario part of the study

• Unwilling to consent to video recording
• Participating in the case scenario part of the study

Healthcare professionals:

• Without any prior hematological experience
• Not licensed as hematologists, nurse practitioners, physician assistants, nurses or pharmacists
• Unable to communicate in English
• Incapable of giving their consent to participate

Specifically for the case scenario part of the study • Unwilling to consent to voice recording

Specifically for the use scenario part of the study

• Unwilling to consent to video recording

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A	One day
Usability issues of the current POC in-vitro diagnostic device prototypes	one day	Overview of identified usability issues
Current management of Hemophilia A coagulation lab testing	One day	Themes regarding the current management of Hemophilia A coagulation lab testing

Secondary Outcome Measures

Name	Time	Method
Potential benefits of a POC device for home use, near-patient use or in clinic use	One day
Problems with current Hemophilia A coagulation monitoring	One day
User preferences for the point of care in-vitro diagnostic device	One day

Trial Locations

Locations (1)

Indiana Hemophilia & Thrombosis Center; 🇺🇸 Indianapolis, Indiana, United States