Hemophilia a
Conditions
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.
Interventions
OTHERCase 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.
OTHERCase 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.
OTHERUse 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).
OTHERUse scenarios - interview
The participants will be interviewed and asked for their opinions and experiences with the mock-ups.
Sponsors
Indiana Hemophilia & Thrombosis Center
Enzyre B.V.
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Current management of Hemophilia A coagulation lab testing | One day | Themes regarding the current management of Hemophilia A coagulation lab testing |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| User preferences for the point of care in-vitro diagnostic device | One day |
| Problems with current Hemophilia A coagulation monitoring | One day |
| Potential benefits of a POC device for home use, near-patient use or in clinic use | One day |
Countries
United States
Outcome results
None listed