Handheld Ultrasound (HHUS) for Home Use in Hemophilia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Outcome 2.2: Accuracy of the assignment of "bleed" vs. "non-bleed" will be determined on the stationary GE LS8 Logiq Pro in the HTC.
研究概览
简要总结
This is a study in 3 phases that will assess the feasibility and utility of handheld home ultrasound (HHUS) in a patient's home to assess whether a painful episode in the elbow, knee or ankle is a bleed or not.
详细描述
This is a study in 3 phases that will assess the feasibility and utility of handheld home ultrasound (HHUS) in a patient's home to assess whether a painful episode in the elbow, knee or ankle is a bleed or not.
Phase 1 will assess whether 10 subjects with severe hemophilia A can be trained to use HHUS in clinic to identify basic joint structures of the elbow, knee and ankle. It will then assess whether these subjects can identify these structures at home and transmit the images life via tele-ultrasound.
Phase 2 will assess whether the determination of "bleed" vs. "non-bleed" made at home via HHUS can be confirmed/validated with a standard high resolution ultrasound machine in clinic.
Phase 3 will then utilize HHUS during the EmiMSKUS study over 3 years to more objectively identify patient reported bleeding during the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe hemophilia A
- •Over 18 years of age
- •Able to read, write and understand English
- •Willing to come to the center for an 8 hour training session
- •Lives in proximity of the HTC and is willing to come in for acute joint episodes in phase 2
- •Willing and able to follow study procedures
- •Willing and able to keep HHUS at a safe place
- •Have the dexterity to operate a HHUS unit
排除标准
- •Unable to follow study instructions
- •Physically or mentally unable to operate a HHUS unit
结局指标
主要结局
Outcome 2.2: Accuracy of the assignment of "bleed" vs. "non-bleed" will be determined on the stationary GE LS8 Logiq Pro in the HTC.
时间窗: 6 months
Percentage accuracy of the assignment of "bleed" vs. "non-bleed" will be determined on the stationary GE LS8 Logiq Pro in the HTC.
Outcome 3.1: To establish how accurate patient reported bleeding is compared to HHUS utilizing tele-ultrasound.
时间窗: 3 years
Percentage accuracy of patient reported bleeding is compared to HHUS utilizing tele-ultrasound.
Outcome 1.1: Participant understanding of basic ultrasound transducer concepts and ability to perform basic positioning maneuvers.
时间窗: 3 months
Number of participating subjects who understand basic ultrasound transducer concepts and can perform basic positioning maneuvers based on post-training test.
Outcome 1.3: Participating subjects can perform what they learned during their training at the HTC in outcome 1.1 and outcome 1.2 at home and transmit images to the HTC.
时间窗: 3 months
Number of participating subjects who can perform what they learned during their training at the HTC in outcome 1.1 and outcome 1.2 at home and transmit images to the HTC on post-training test.
Outcome 3.2: To establish more accurate bleeding data for the EmiMSKUS study.
时间窗: 3 years
Number of patients who have joint bleeding data incorporated into the EmiMSKUS study.
Outcome 1.2: Participating subjects are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle.
时间窗: 3 months
Number of participating subjects who are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle based on post-training test.
Outcome 2.1: Subjects will be able to attain and transmit images of their joint spaces to the HTC via telemedicine utilizing the HHUS technology they learned in phase 1 and React App.
时间窗: 6 months
Number of subjects who will be able to attain and transmit images of their joint spaces to the HTC via telemedicine utilizing the HHUS technology they learned in phase 1 and React App.
次要结局
未报告次要终点
研究者
Rebecca Kruse-Jarres, MD, MPH
Executive/Medical Director, Washington Center for Bleeding Disorders
Washington Institute for Coagulation