Remote Temperature Monitoring of Patients At Risk for Developing Fever
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote Patient Monitoring.
- Who it may be relevant to
- Registry conditions: Fever, Cancer, Remote Patient Monitoring. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device Remote Patient Monitoring
24/7 remote patient monitoring with a wearable thermometer
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Mean out-of-pocket cost [Time frame: Day of enrollment]
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Ellis Hospital — Schenectady
Identifiers
NCT: NCT06752512 · ELLIS001