REMEDY: Remote Outpatient Temperature Monitoring for Early Detection of Febrile Neutropenia After Chemotherapy

Sponsor

Augusta University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04081753

Collaborator

University of Georgia (Other)

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Febrile neutropenic patients are at high risk for developing sepsis and other infections which often necessitates acute admission to the Intensive Care Unit (ICU) and are associated with high mortality. Neutropenic fever is a medical emergency and early detection of fever allows for prompt infectious work up. In this study, the investigators will collect pilot data from outpatients utilizing a remote outpatient continuous temperature monitoring device to compare the incidence of ICU admission and severe sepsis to historical data for prior patients who did not receive at home monitoring device.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML)	Device: Remote monitoring of temperature	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Interventional group will be compared with historic group of patientsInterventional group will be compared with historic group of patients

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Remote Outpatient Temperature Monitoring for Early Detection of Febrile Neutropenia After Chemotherapy

Actual Study Start Date :

Dec 16, 2019

Anticipated Primary Completion Date :

Apr 30, 2020

Anticipated Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TMD Group Temperature Monitoring Device Group - The interventional group, who will be given the temperature monitoring device and will be monitored remotely.	Device: Remote monitoring of temperature The patient will be set up with a remote monitoring device for temperature recording and the temperature will monitored remotely
No Intervention: Historic cohort Group Historic cohort group will be enrolled from medical record

Arm

Intervention/Treatment

Experimental: TMD Group

Temperature Monitoring Device Group - The interventional group, who will be given the temperature monitoring device and will be monitored remotely.

Device: Remote monitoring of temperature

The patient will be set up with a remote monitoring device for temperature recording and the temperature will monitored remotely

No Intervention: Historic cohort Group

Historic cohort group will be enrolled from medical record

Outcome Measures

Primary Outcome Measures

Change ICU admission [1 month]
The interventional group will have less number of ICU admission
Change incidence of sepsis in interventional group [1 month]
The interventional group will have chnaged rate of sepsis incidence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who have acute myeloid leukemia (AML) and are candidates for consolidation chemotherapy with high dose cytarabine (HiDAC) after successful remission induction chemotherapy

Both male and female
Age 18 years and older

Exclusion Criteria:

Patients who have already developed febrile neutropenia during their hospitalization for their consolidative cycle of chemotherapy will not be eligible for monitoring for that cycle; however, these patients will be able to participate in subsequent cycle if they do not develop febrile neutropenia during their subsequent HiDAC hospitalization.

• If a patient is admitted to the hospital between cycles of chemotherapy for reasons other than febrile neutropenia or its sequelae, they will be taken off study for that cycle and data not collected while they are admitted