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

Hemophilia A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369740
• Other study ID #: ENZ20-2024-INDIANAPOLIS
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 4, 2024

Study information

• Verified date: April 2024
• Source: Enzyre B.V.
• Contact: Waander Van Heerde, PhD
• Phone: +31 024 6690036
• Email: w.vanheerde[@]enzyre.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: June 4, 2024
• Est. primary completion date: June 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A

Intervention

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.
• 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.
• 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).
• Use scenarios - interview
The participants will be interviewed and asked for their opinions and experiences with the mock-ups.

Locations

Country	Name	City	State
United States	Indiana Hemophilia & Thrombosis Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Enzyre B.V.	Indiana Hemophilia & Thrombosis Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current management of Hemophilia A coagulation lab testing	Themes regarding the current management of Hemophilia A coagulation lab testing	One day
Primary	Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A		One day
Primary	Usability issues of the current POC in-vitro diagnostic device prototypes	Overview of identified usability issues	one day
Secondary	User preferences for the point of care in-vitro diagnostic device		One day
Secondary	Problems with current Hemophilia A coagulation monitoring		One day
Secondary	Potential benefits of a POC device for home use, near-patient use or in clinic use		One day