Remote Temperature Monitoring of Patients At Risk for Developing Fever

AION Biosystems

Status

Enrolling

Conditions

Fever

Remote Patient Monitoring

Cancer

Treatments

Device: Remote Patient Monitoring

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06752512

ELLIS001

Details and patient eligibility

About

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

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
Subject is willing to allow AION to send text reminders to take temperature or complete surveys.
Subject is willing to take an oral temperature as directed by their care plan.
Subject is willing to configure the phone to ensure these notifications are delivered, even when phone is in a "no notification" mode.
Subject or subject caretaker is able and willing to complete subject surveys.
Subject is willing and able to provide written informed consent in English.
Subject is willing and able to comply with all program procedures, requirements, assessments, visits, and complete questionnaires.
English speakers

Exclusion criteria

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.
Subjects receiving prophylactics that could induce fever.
Subjects with a silicon allergy
Subject does not have iOS or Android phone, and is unable to operate an AION provided smartphone device.
Subjects who are not willing to take an oral temperature per their care plan.