Hemophilia A, Joint Bleed
Conditions
Keywords
Joint Bleed, Hemophilia A, Handheld Ultrasound
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.
Interventions
DEVICEhandheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform
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.
Sponsors
Genentech, Inc.
Washington Institute for Coagulation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome 1.1: Participant understanding of basic ultrasound transducer concepts and ability to perform basic positioning maneuvers. | 3 months | Number of participating subjects who understand basic ultrasound transducer concepts and can perform basic positioning maneuvers based on post-training test. |
| Outcome 1.2: Participating subjects are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle. | 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 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. | 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 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. | 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. |
| 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. | 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. | 3 years | Percentage accuracy of patient reported bleeding is compared to HHUS utilizing tele-ultrasound. |
| Outcome 3.2: To establish more accurate bleeding data for the EmiMSKUS study. | 3 years | Number of patients who have joint bleeding data incorporated into the EmiMSKUS study. |
Countries
United States
Outcome results
None listed