Handheld Ultrasound (HHUS) for Home Use in Hemophilia

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Handheld Ultrasound (HHUS) for Home Use in Hemophilia

Conditions
-----------------
Joint Bleed, Hemophilia A

Intervention / Treatment
-----------------
* Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe hemophilia A Male 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 Exclusion Criteria: Unable to follow study instructions Physically or mentally unable to operate a HHUS unit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase 1 and 2<br>10 male patients with severe Hemophilia A from the Washington Center for Bleeding Disorders | Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform<br>* Patients receive training by the physical therapist to operate a handheld ultrasound (HHUS) including proper probe placement. Subjects will be tested on their knowledge at the HTC to demonstrate proficiency, and will then repeat the testing at home via tele-ultrasound.<br>|
| Phase 3<br>20 subjects who are also participating in the EmiMSKUS study | Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform<br>* Patients receive training by the physical therapist to operate a handheld ultrasound (HHUS) including proper probe placement. Subjects will be tested on their knowledge at the HTC to demonstrate proficiency, and will then repeat the testing at home via tele-ultrasound.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome 1.1: Participant understanding of basic ultrasound transducer concepts and ability to perform basic positioning maneuvers. | Number of participating subjects who understand basic ultrasound transducer concepts and can perform basic positioning maneuvers based on post-training test. | 3 months | 
| Outcome 1.2: Participating subjects are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle. | 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. | 3 months | 
| 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. | 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. | 3 months | 
| 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. | 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. | 6 months | 
| 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. | Percentage accuracy of the assignment of bleed vs. non-bleed will be determined on the stationary GE LS8 Logiq Pro in the HTC. | 6 months | 
| Outcome 3.1: To establish how accurate patient reported bleeding is compared to HHUS utilizing tele-ultrasound. | Percentage accuracy of patient reported bleeding is compared to HHUS utilizing tele-ultrasound. | 3 years | 
| Outcome 3.2: To establish more accurate bleeding data for the EmiMSKUS study. | Number of patients who have joint bleeding data incorporated into the EmiMSKUS study. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Joint Bleed, Hemophilia A, Handheld Ultrasound