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NCT Number: NCT06369740

Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia a Monitoring

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana Hemophilia & Thrombosis Center

Indianapolis, Indiana, 46260, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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).

Use scenarios - interview

Other

The participants will be interviewed and asked for their opinions and experiences with the mock-ups.

Primary outcomes

  1. Current management of Hemophilia A coagulation lab testing

    Time frame: One day

    Themes regarding the current management of Hemophilia A coagulation lab testing

  2. Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A

    Time frame: One day

  3. Usability issues of the current POC in-vitro diagnostic device prototypes

    Time frame: one day

    Overview of identified usability issues

Secondary outcomes

  1. User preferences for the point of care in-vitro diagnostic device

    Time frame: One day

  2. Problems with current Hemophilia A coagulation monitoring

    Time frame: One day

  3. Potential benefits of a POC device for home use, near-patient use or in clinic use

    Time frame: One day

Sponsors and collaborators

Lead sponsor

Enzyre B.V.

Industry

Collaborators

  • Indiana Hemophilia &Thrombosis Center, Inc.

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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