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

Enzyre

Status: Completed

Conditions: Hemophilia a

Treatments: Other: Use scenarios - Usability test; Other: Case scenarios - questionnaire; Other: Use scenarios - interview; Other: Case scenarios - Focus groups

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06369740

ENZ20-2024-INDIANAPOLIS

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

74 participants in 4 patient groups

Hemophilia A patients - case scenario focus groups

Description:

60 patients with hemophilia A aged 12 years and older that partake in the case scenario focus groups

Treatment:

Other: Case scenarios - Focus groups

Other: Case scenarios - questionnaire

Healthcare providers - case scenario focus groups

Description:

30 healthcare providers with experience in the field of hemophilia A that partake in the case scenario focus groups

Treatment:

Other: Case scenarios - Focus groups

Other: Case scenarios - questionnaire

Hemophilia A patients - use scenarios

Description:

6 patients with hemophilia A aged 12 years and older that partake in the use scenarios usability evaluation

Treatment:

Other: Use scenarios - interview

Other: Use scenarios - Usability test

Healthcare providers - use scenarios

Description:

6 healthcare providers with experience in the field of hemophilia A that partake in the use scenarios usability evaluation

Treatment:

Other: Use scenarios - interview

Other: Use scenarios - Usability test