Actively Recruiting
Remote Temperature Monitoring of Patients At Risk for Developing Fever
Led by AION Biosystems · Updated on 2024-12-30
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AION Biosystems
Lead Sponsor
E
Ellis Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate continuous remote temperature monitoring in cancer patients who are at risk of developing fever and infection due to chemotherapy treatment. The study focuses on whether this monitoring can reduce the number of days patients spend hospitalized, the out-of-pocket costs they might face, and the number of billable medical codes generated. The program compares patients who comply with the remote temperature monitoring to those who do not, to see if compliance is linked to fewer inpatient days. Participants will wear a wearable thermometer device throughout their study participation, allowing 24/7 remote temperature monitoring. Physicians can configure alert thresholds for sustained high temperatures, triggering notifications sent to patients' phones. Participants will receive alerts when their temperature exceeds these limits and will be contacted by remote monitors via text or phone calls when an alert occurs. During the study, patients will be monitored continuously and their temperature data collected. Researchers will measure the average number of inpatient days from enrollment up to 180 days, along with participants' out-of-pocket costs and the number of billing codes generated. The study involves completing surveys, responding to alerts, and using the TempShield app. Safety and compliance will be tracked over a maximum participation period of 180 days after enrollment.
CONDITIONS
Brief Title
Remote Temperature Monitoring of Patients At Risk for Developing Fever
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for informed consent and eligibility assessment
Duration - Up to 180 days after enrollment
Participants are remotely monitored 24/7 using a wearable thermometer and a mobile app to track temperature and complete surveys.
Continuous remote monitoring with app notifications and temperature recordings
Trial Site Locations
Total: 1 location
1
Ellis Hospital
Schenectady, New York, United States, 12308
Actively Recruiting
Research Team
D
David Colburn, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here