Purpose of this Study
We are doing this study to evaluate the performance of an experimental medical technology called the Patched Sepsis Prediction Algorithm (the study technology). This technology is designed to detect the early signs of sepsis and give clinicians the chance to treat it earlier than usual.
Who Can Participate?
Eligibility
Adults who:<ul>
<li>Are scheduled to receive, are actively receiving, or have recently received (within the past 7 days) cytotoxic chemotherapy and/or bone marrow transplantation</li>
<li>Are diagnosed with a hematologic malignancy</li>
<li>Are capable of using vitals-sign monitoring equipment and smartphone applications or have access to assistance for their use</li>
<li>Own an Android or iOS smartphone</li>
<li>Do not have uncontrolled arrhythmia, a cardiac pacemaker or a left ventricular assist device</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: terri.lucas@duke.edu">terri.lucas@duke.edu</a> or 919-681-6580.
<li>Are scheduled to receive, are actively receiving, or have recently received (within the past 7 days) cytotoxic chemotherapy and/or bone marrow transplantation</li>
<li>Are diagnosed with a hematologic malignancy</li>
<li>Are capable of using vitals-sign monitoring equipment and smartphone applications or have access to assistance for their use</li>
<li>Own an Android or iOS smartphone</li>
<li>Do not have uncontrolled arrhythmia, a cardiac pacemaker or a left ventricular assist device</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: terri.lucas@duke.edu">terri.lucas@duke.edu</a> or 919-681-6580.
What is Involved?
If you choose to join this study, you will go through a screening/training visit. During this screening/training/visit, you will:<ul>
<li>Answer questionnaires</li>
<li>Learn how to use the study technology</li></ul>
During the study, you will wear continuous vital-sign monitoring equipment for the study monitoring period. The study kit will be provided to recruited patients following discharge from the hospital or in outpatient clinic after chemotherapy and will be worn for the entire monitoring period. The system will not be set up to trigger any alerts, only to collect data.
Your participation in the study will last for up to 90 days.
<li>Answer questionnaires</li>
<li>Learn how to use the study technology</li></ul>
During the study, you will wear continuous vital-sign monitoring equipment for the study monitoring period. The study kit will be provided to recruited patients following discharge from the hospital or in outpatient clinic after chemotherapy and will be worn for the entire monitoring period. The system will not be set up to trigger any alerts, only to collect data.
Your participation in the study will last for up to 90 days.
Study Details
Full Title
Patchd - Prediction of Sepsis in a High-Risk Post-Acute Care Population
Principal Investigator
Lindsay
Rein
Protocol Number
PRO00112372
Phase
0
Enrollment Status
Pending Open to Enrollment