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

NCT06369740 | Completed

• 1 other identifier: ENZ20-2024-INDIANAPOLIS
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia a

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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

  One day

Study Arms (4)

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; Other: Case scenarios - 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

Other: Case scenarios - questionnaire; Other: Case scenarios - 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

Other: Use scenarios - Usability test; Other: Use scenarios - interview

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; Other: Use scenarios - interview

Interventions

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.

Healthcare providers - case scenario focus groups; Hemophilia A patients - case scenario focus groups

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.

Healthcare providers - case scenario focus groups; Hemophilia A patients - case scenario focus groups

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).

Healthcare providers - use scenarios; Hemophilia A patients - use scenarios

Use scenarios - interview OTHER

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

Healthcare providers - use scenarios; Hemophilia A patients - use scenarios

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Enzyre B.V.: lead
• Indiana Hemophilia & Thrombosis Center: collaborator

Study Sites (1)

Indiana Hemophilia & Thrombosis Center

Indianapolis, Indiana, 46260, United States

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: August 22, 2024
• Primary Completion: August 25, 2024
• Study Completion: August 25, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)