Remote Temperature Monitoring of Patients At Risk for Developing Fever

NCT06752512 | Recruiting FDA Device

• 1 other identifier: ELLIS001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Fever; Cancer; Remote Patient Monitoring

Keywords

fever; infection; sepsis; cancer; chemotherapy; immunocompromised; temperature; wearable; remote patient monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean out-of-pocket cost

  Day of enrollment

• Number of CPT codes generated

  Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment

Study Arms (1)

Remote Patient Monitoring

EXPERIMENTAL

Patients assigned remote patient monitoring

Device: Remote Patient Monitoring

Interventions

Remote Patient Monitoring DEVICE

24/7 remote patient monitoring with a wearable thermometer

Also known as: RPM

Remote Patient Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AION Biosystems: lead
• Ellis Medicine: collaborator

Study Sites (1)

Ellis Hospital

Schenectady, New York, 12308, United States

RECRUITING

MeSH Terms

Conditions

Fever; Neoplasms; Infections; Sepsis

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Study Officials

• Tallat Mahmood, M.D.

  Ellis Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Colburn, Ph.D.

CONTACT

(757) 641-2019; d.alexander.colburn@aionbioystems.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 30, 2024
• Study Start: August 9, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)