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NCT Number: NCT06752512

Remote Temperature Monitoring of Patients At Risk for Developing Fever

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

Recruiting

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Key information

Conditions

Fever Body Temperature Changes Cancer Infections Inflammation Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Remote Patient Monitoring Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ellis Hospital

Schenectady, New York, 12308, United States

Location status: Recruiting

Location contact

Elise Currier

CONTACT

[email protected]

(704) 307-1253

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Patient Monitoring

Device

24/7 remote patient monitoring with a wearable thermometer

Other names: RPM

Primary outcomes

  1. 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

Secondary outcomes

  1. Mean out-of-pocket cost

    Time frame: Day of enrollment

    The patient's out-of-pocket expense for setup of remote patient monitoring

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

David Colburn, Ph.D.

CONTACT

[email protected]

(757) 641-2019

Sponsors and collaborators

Lead sponsor

AION Biosystems

Industry

Collaborators

  • Ellis Medicine

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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