Remote Temperature Monitoring of Patients At Risk for Developing Fever

Обзор

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

Вмешательства

• Устройство Remote Patient Monitoring
  24/7 remote patient monitoring with a wearable thermometer

Первичные конечные точки

• Mean number of inpatient days [Срок оценки: Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment]

Вторичные конечные точки (2)

• Mean out-of-pocket cost [Срок оценки: Day of enrollment]
• Number of CPT codes generated [Срок оценки: Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Ellis Hospital — Schenectady

Идентификаторы

NCT: NCT06752512 · ELLIS001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗