Remote Temperature Monitoring of Patients At Risk for Developing Fever

December 22, 2024 updated by: AION Biosystems

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

This is where you will find people and organizations involved with this study.

Sponsor

AION Biosystems

Collaborators

Ellis Medicine

Investigators

  • Principal Investigator: Tallat Mahmood, M.D., Ellis Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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