Clinical trial NCT06752512: Remote Temperature Monitoring of Patients At Risk for Developing Fever
Official title: Remote Temperature Monitoring of Patients At Risk for Developing Fever
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fever
Cancer
Remote Patient Monitoring
Keywords: fever
infection
sepsis
cancer
chemotherapy
immunocompromised
temperature
wearable
remote patient monitoring
Lead sponsor: AION Biosystems
Sponsor class: INDUSTRY
Collaborators: name: Ellis Medicine
First posted: 2024-12-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Primary outcomes:
measure: Mean number of inpatient days
timeFrame: Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment
Secondary outcomes:
measure: Mean out-of-pocket cost
timeFrame: Day of enrollment
measure: Number of CPT codes generated
timeFrame: Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment
Other outcomes:
Locations:
city: Schenectady
country: United States
facility: Ellis Hospital
state: New York
Study officials:
affiliation: Ellis Hospital
name: Tallat Mahmood, M.D.
role: PRINCIPAL_INVESTIGATOR
References: