Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia a Monitoring
NCT ID: NCT06369740
Last Updated: 2024-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
74 participants
OBSERVATIONAL
2024-08-22
2024-08-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Hemophilia A patients - case scenario focus groups
60 patients with hemophilia A aged 12 years and older that partake in the case scenario focus groups
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.
Healthcare providers - case scenario focus groups
30 healthcare providers with experience in the field of hemophilia A that partake in the case scenario focus groups
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.
Hemophilia A patients - use scenarios
6 patients with hemophilia A aged 12 years and older that partake in the use scenarios usability evaluation
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.
Healthcare providers - use scenarios
6 healthcare providers with experience in the field of hemophilia A that partake in the use scenarios usability evaluation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Indiana Hemophilia & Thrombosis Center
UNKNOWN
Enzyre B.V.
INDUSTRY
Responsible Party
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Locations
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Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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ENZ20-2024-INDIANAPOLIS
Identifier Type: -
Identifier Source: org_study_id
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