NCT06369740Completed
Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia a Monitoring
Source: ClinicalTrials.gov · Last updated 29 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 74 (actual)
- First submitted
- 12 Apr 2024
- Start date
- Aug 2024
- Primary completion date
- Aug 2024
- Lead sponsor
- Enzyre B.V.
- Diseases
- Haemophilia
- NCT number
- NCT06369740
What you commit to
- Study type: Observational
- Participants enrolled: 74
- From Aug 2024 to the primary completion date, Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Without any prior hematological experience
Age
- Younger than 12 years of age
- Younger than 18 years of age
Other
- Patients:
- Without a diagnosis of Hemophilia A
- With acquired Hemophilia A
- 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
- 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:
- 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
Who the study is looking for
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana Hemophilia & Thrombosis Center Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.