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

October 25, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Enzyre B.V.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Hemophilia a

Clinical Trials on Case scenarios - questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings