Recruiting

Observational Study

Sponsor:

AION Biosystems

Code:

NCT06752512

Conditions

Fever

Cancer

Remote Patient Monitoring

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remote Patient Monitoring

Study Details

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

Study ID

NCT06752512

Start date

Aug 9, 2023

Status verified date

Dec, 2024

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Remote Patient Monitoring

Patients assigned remote patient monitoring

Interventions

Remote Patient Monitoring

24/7 remote patient monitoring with a wearable thermometer

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

David Colburn, Ph.D.

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

Locations

Ellis Hospital

Recruiting

Schenectady, New York, United States, 12308

Contacts

Elise Currier

(704) 307-1253curriere4s@ellismedicine.org

More Information

Sponsor

AION Biosystems

Last update posted

Dec 30, 2024

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AION Biosystems on 2024-12-30.