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| Name | Class |
|---|---|
| Indiana Hemophilia &Thrombosis Center, Inc. | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| Hemophilia A patients - use scenarios | 6 patients with hemophilia A aged 12 years and older that partake in the use scenarios usability evaluation |
| |
| Healthcare providers - use scenarios | 6 healthcare providers with experience in the field of hemophilia A that partake in the use scenarios usability evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Case scenarios - questionnaire | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Current management of Hemophilia A coagulation lab testing | Themes regarding the current management of Hemophilia A coagulation lab testing | One day |
| 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 | Overview of identified usability issues | one day |
| Measure | Description | 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 |
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Inclusion Criteria:
Patients:
Family member(s) of patients:
Healthcare professionals:
Exclusion Criteria:
Patients:
Specifically for the case scenario focus group
Specifically for the use scenario part of the study
Family members:
Specifically for the case scenario focus group
Specifically for the use scenario part of the study
Healthcare professionals:
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
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Hemophilia & Thrombosis Center | Indianapolis | Indiana | 46260 | United States |
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| Case scenarios - Focus groups | Other | 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. |
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| Use scenarios - Usability test | Other | 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). |
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| Use scenarios - interview | Other | The participants will be interviewed and asked for their opinions and experiences with the mock-ups. |
|
| One day |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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