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NCT06752512 | RECRUITING | Fever

Remote Temperature Monitoring of Patients At Risk for Developing Fever
Sponsor:

AION Biosystems

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

Condition or disease

Fever

Cancer

Remote Patient Monitoring

Intervention/treatment

Remote Patient Monitoring

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Remote Temperature Monitoring of Patients At Risk for Developing Fever
Actual Study Start Date : 2023-08-09
Estimated Primary Completion Date : 2025-01
Estimated Study Completion Date : 2025-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Remote Temperature Monitoring of Patients At Risk for Developing Fever

Location Details

NCT06752512

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Ellis Hospital

Schenectady, New York, United States, 12308