NCT06752512 Remote Temperature Monitoring of Patients At Risk for Developing Fever
| NCT ID | NCT06752512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AION Biosystems |
| Condition | Fever |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-08-09 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-08-09 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Tallat Mahmood, M.D.
PRINCIPAL INVESTIGATOR
Ellis Hospital
Frequently Asked Questions
Who can join the NCT06752512 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fever. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06752512 currently recruiting?
Yes, NCT06752512 is actively recruiting participants. Contact the research team at d.alexander.colburn@aionbioystems.com for enrollment information.
Where is the NCT06752512 trial being conducted?
This trial is being conducted at Schenectady, United States.
Who is sponsoring the NCT06752512 clinical trial?
NCT06752512 is sponsored by AION Biosystems. The principal investigator is Tallat Mahmood, M.D. at Ellis Hospital. The trial plans to enroll 150 participants.