RECRUITING

Remote Temperature Monitoring of Patients At Risk for Developing Fever

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Remote Temperature Monitoring of Patients At Risk for Developing Fever

Quick Facts

Study Start:2023-08-09
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06752512

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is at risk of a fever post discharge.
  2. * Subject is ≥ 18 years or older.
  3. * Subject has an iOS or Android phone, or is able to operate an AION provided smartphone device.
  4. * Subject is willing to install the TempShield app on his/her phone.
  5. * Subject is willing to allow AION to send text reminders to take temperature or complete surveys.
  6. * Subject is willing to take an oral temperature as directed by their care plan.
  7. * Subject is willing to configure the phone to ensure these notifications are delivered, even when phone is in a "no notification" mode.
  8. * Subject or subject caretaker is able and willing to complete subject surveys.
  9. * Subject is willing and able to provide written informed consent in English.
  10. * Subject is willing and able to comply with all program procedures, requirements, assessments, visits, and complete questionnaires.
  11. * English speakers
  1. * Unable to provide informed consent
  2. * Subjects with a history of Medical Adhesive-Related Skin Injury (MARSI)
  3. * Subjects with no available placement that avoids open wounds or traumatized skin (burns. Blisters. Etc.)
  4. * Non-English speakers: The mobile application is only currently available in English. Future development will include other languages.
  5. * Subjects receiving prophylactics that could induce fever.
  6. * Subjects with a silicon allergy
  7. * Subject does not have iOS or Android phone, and is unable to operate an AION provided smartphone device.
  8. * Subjects who are not willing to take an oral temperature per their care plan.

Contacts and Locations

Study Contact

David Colburn, Ph.D.
CONTACT
(757) 641-2019
d.alexander.colburn@aionbioystems.com

Principal Investigator

Tallat Mahmood, M.D.
PRINCIPAL_INVESTIGATOR
Ellis Hospital

Study Locations (Sites)

Ellis Hospital
Schenectady, New York, 12308
United States

Collaborators and Investigators

Sponsor: AION Biosystems

  • Tallat Mahmood, M.D., PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-08-09
Study Completion Date2025-01

Study Record Updates

Study Start Date2023-08-09
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Fever
  • Cancer
  • Remote Patient Monitoring