Remote Temperature Monitoring of Patients At Risk for Developing Fever

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Fever; Remote Patient Monitoring
• Intervention / Treatment: Device: Remote Patient Monitoring

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Colburn, Ph.D.; Phone Number: (757) 641-2019; Email: d.alexander.colburn@aionbioystems.com

Study Locations

• United States
  • New York
    • Schenectady, New York, United States, 12308
      • Recruiting
      • Ellis Hospital
      • Contact: Elise Currier; Phone Number: (704) 307-1253; Email: curriere4s@ellismedicine.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Patient Monitoring; Patients assigned remote patient monitoring	Device: Remote Patient Monitoring; 24/7 remote patient monitoring with a wearable thermometer; Other Names: RPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of inpatient days	The number of days the participant was admitted to a hospital while receiving remote patient monitoring	Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean out-of-pocket cost	The patient's out-of-pocket expense for setup of remote patient monitoring	Day of enrollment
Number of CPT codes generated	Number of CPT codes generated for remote patient monitoring	Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment

Collaborators and Investigators

• Sponsor: AION Biosystems
• Collaborators: Ellis Medicine
• Investigators: Principal Investigator: Tallat Mahmood, M.D., Ellis Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: December 22, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: chemotherapy; cancer; fever; temperature; wearable; infection; sepsis; remote patient monitoring; immunocompromised
• Additional Relevant MeSH Terms: Body Temperature Changes; Fever
• Other Study ID Numbers: ELLIS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No