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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia (AML)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Interventional group will be compared with historic group of patients

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TMD Group

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

Group Type EXPERIMENTAL

Remote monitoring of temperature

Intervention Type DEVICE

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

Historic cohort Group

Historic cohort group will be enrolled from medical record

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote monitoring of temperature

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No