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

April 12, 2024 updated by: Enzyre B.V.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Indiana Hemophilia & Thrombosis center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Case scenarios - questionnaire
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.
Other: Case scenarios - Focus groups
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.
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
Other: Case scenarios - questionnaire
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.
Other: Case scenarios - Focus groups
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.
Hemophilia A patients - use scenarios
6 patients with hemophilia A aged 12 years and older that partake in the use scenarios usability evaluation
Other: Use scenarios - Usability test
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).
Other: Use scenarios - interview
The participants will be interviewed and asked for their opinions and experiences with the mock-ups.
Healthcare providers - use scenarios
6 healthcare providers with experience in the field of hemophilia A that partake in the use scenarios usability evaluation
Other: Use scenarios - Usability test
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).
Other: Use scenarios - interview
The participants will be interviewed and asked for their opinions and experiences with the mock-ups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current management of Hemophilia A coagulation lab testing
Time Frame: One day
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
Time Frame: One day
One day
Usability issues of the current POC in-vitro diagnostic device prototypes
Time Frame: one day
Overview of identified usability issues
one day

Secondary Outcome Measures

Outcome Measure
Time Frame
User preferences for the point of care in-vitro diagnostic device
Time Frame: One day
One day
Problems with current Hemophilia A coagulation monitoring
Time Frame: One day
One day
Potential benefits of a POC device for home use, near-patient use or in clinic use
Time Frame: One day
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enzyre B.V.

Collaborators

Indiana Hemophilia & Thrombosis Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 4, 2024

Study Completion (Estimated)

June 4, 2024

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENZ20-2024-INDIANAPOLIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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