Clinical trial NCT06369740: Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia a Monitoring
Official title: Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia a Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia a
Lead sponsor: Enzyre B.V.
Sponsor class: INDUSTRY
Collaborators: name: Indiana Hemophilia & Thrombosis Center
First posted: 2024-04-17
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients or caregivers of patients with hemophilia A of any severity (mild, moderate, severe) aged 12 years and older are considered. Patients have tbe able to speak English and have give informed consent. In patients ages 12-17, parents will also have to give informed consent. Patients are not allowed to participate in both the use scenarios and the case scenarios parts of the study.

Healthcare providers specialized in hemophilia care are also included. This could be hematologists, nurse practitioners, physician assistents, nurses and pharmacists.

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.


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

Primary outcomes:
measure: Current management of Hemophilia A coagulation lab testing
timeFrame: One day
measure: Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A
timeFrame: One day
measure: Usability issues of the current POC in-vitro diagnostic device prototypes
timeFrame: one day
Secondary outcomes:
measure: User preferences for the point of care in-vitro diagnostic device
timeFrame: One day
measure: Problems with current Hemophilia A coagulation monitoring
timeFrame: One day
measure: Potential benefits of a POC device for home use, near-patient use or in clinic use
timeFrame: One day
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Hemophilia & Thrombosis Center
state: Indiana
Study officials:
References: