case and use scenario study to gain knowledge on the user needs for a medical device for hemophilia a monitoring

Conditions: Hemophilia a

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.


Eligibility criteria:
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