Remote Temperature Monitoring of Patients At Risk for Developing Fever
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAION Biosystems
About this trial
The purpose of this program is to evaluate remote temperature monitoring in cancer patients at risk of fever and infection due to chemotherapy treatment. The main questions it aims to answer are:
* does remote temperature monitoring reduce the number of days spent inpatient * what out-of-pocket cost can a patient expect to incur for participating in remote temperature monitoring * the number of billable CPT codes that will be generated by providing remote temperature monitoring
Researchers will compare compliant and non-compliant patients to assess if compliance with remote temperature monitoring is associated with a decrease in the number of days spent inpatient.
Patients will
* wear the thermometer for the duration of their participation in the study * have their temperature monitored continuously * receive alerts on their phone when their temperature exceeds a threshold for a sustained duration, configurable by their physician * respond to texts or calls from remote monitors when an alert is triggered
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is at risk of a fever post discharge.
Subject is ≥ 18 years or older.
Subject has an iOS or Android phone, or is able to operate an AION provided smartphone device.
Subject is willing to install the TempShield app on his/her phone.
Disqualifiers
Unable to provide informed consent
Subjects with a history of Medical Adhesive-Related Skin Injury (MARSI)
Subjects with no available placement that avoids open wounds or traumatized skin (burns. Blisters. Etc.)
Non-English speakers: The mobile application is only currently available in English. Future development will include other languages.
Trial design
Design model
Single group
Treatments tested in this trial
Remote Patient Monitoring
Device24/7 remote patient monitoring with a wearable thermometer
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Remote Patient MonitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean number of inpatient days
The number of days the participant was admitted to a hospital while receiving remote patient monitoring
Time frame
Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollmentSecondary outcomes
1
Mean out-of-pocket cost
The patient's out-of-pocket expense for setup of remote patient monitoring
Time frame
Day of enrollment2
Number of CPT codes generated
Number of CPT codes generated for remote patient monitoring
Time frame
Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
AION Biosystems
Lead sponsor
Ellis Medicine
Collaborator
Source ClinicalTrials.gov