NCT06369740已完成不适用
Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia a Monitoring
Enzyre B.V.1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年8月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A
时间窗: One day
Usability issues of the current POC in-vitro diagnostic device prototypes
时间窗: one day
Overview of identified usability issues
Current management of Hemophilia A coagulation lab testing
时间窗: One day
Themes regarding the current management of Hemophilia A coagulation lab testing
次要结局
- Potential benefits of a POC device for home use, near-patient use or in clinic use(One day)
- Problems with current Hemophilia A coagulation monitoring(One day)
- User preferences for the point of care in-vitro diagnostic device(One day)
研究者
研究点 (1)
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