Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies

• ClinicalTrials.gov Identifier: NCT02410252
• Recruitment Status: Completed
• First Posted: April 7, 2015
• Results First Posted: July 31, 2018
• Last Update Posted: October 22, 2020
• Sponsor: Massachusetts General Hospital
• Collaborator: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Joseph C. Kvedar, Massachusetts General Hospital

Study Description

Brief Summary:

This is a pilot study to evaluate the use feasibility of the iThermonitor, a continuous temperature monitoring device, as a clinical support and patient self-management tool in the management of pediatrics patients on myelosuppressive therapies for acute leukemia and other childhood cancers.

Condition or disease	Intervention/treatment	Phase
Acute Lymphocytic Leukemia; Acute Myeloid Leukemia; Non-Hodgkin Lymphoma	Device: iThermonitor	Not Applicable

Detailed Description:

Neutropenia, secondary to myelosupressive therapies, predisposes patients to significant risk for infectious complications which increases morbidity and mortality. Usually, fever is the first clinical sign of the inflammatory response to the infective process; and early detection is an indication for empiric antimicrobial therapy and further evaluation to determine risk for sepsis. Today, broad-spectrum antimicrobial therapy at the first detection of fever has helped significantly decreased the mortality associated with neutropenia in the intensive phase of chemotherapy. Therefore, early detection of fever, through regular temperature monitoring, in a neutropenic patient is critical to improved clinical outcome. Vigilance on the part of care providers and care givers is crucial to early detection. Traditionally, this is simply done through episodic oral or axillary monitoring of temperature. In this study, we propose to test the use feasibility of an innovative device that continuously monitors body temperature as a clinical decision support tool in pediatric patients undergoing myelosuppressive therapies for acute leukemias and other childhood cancers.

The iThermonitor, a FDA class II device, is a high accuracy device that continuously monitors body temperature and connects to a receiver (iPad mini) via bluetooth to display body temperature data in real time. The iThermonitor is attached to the skin by a hydrogel dressing which can be changed as needed. It captures data even without connection to a receiver and it can establish connection to a paired receiver device (the iPad mini) within a range of three meters. The provided iPad mini will be pre-loaded with the iThermonitor app which will be used to pair the receiver with the iThermonitor device. The device monitors body temperature every four seconds and is able to store 10 days worth of data that can be offloaded as soon as it establishes connection with a receiver. It is able to measure temperature in the range of 25-45 degrees Celsius. Users are able to set temperature limits at which alerts for which out-of-range temperature can go off. It also provides care providers an opportunity to remotely monitor their patients' temperature in the immediate period after discharge from the hospital. Therefore, we hypothesize that the iThermonitor can serve as a feasible clinical decision support in the management of pediatric patients undergoing intensive treatments for acute leukemia and other childhood cancers.

This study will be implemented as a pilot study to test the use feasibility of the iThermonitor as a clinical decision support for continuous temperature monitoring in a dyad of 25 pediatrics patients, (aged 2yrs - 17yrs) on myelosuppressive therapies for acute leukemia and other childhood cancers at the MGH Pediatric Hematology and Oncology group, and their caregivers. The iThermonitor will be used by patients and their caregivers at home over a 2-week study period starting from the day after chemotherapy. There will be two study visits: study enrollment and study closeout.

The investigators have chosen to implement this study as a feasibility study because the investigators' goal is to determine if continuous temperature monitoring by the iThermonitor can work in home settings. To the investigators' knowledge, the researchers are not aware of any previous research exploring continuous temperature monitoring in pediatric oncology patients on myelosuppresive therapies. Therefore, findings from this study have the potential to advance knowledge about the management of fever in pediatric patients on myelosuppresive therapies.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Use Feasibility of the iThermonitor in Pediatric Patients on Myelosuppresive Therapies for Acute Leukemia and Other Childhood Cancers
• Study Start Date: May 2015
• Actual Primary Completion Date: July 2017
• Actual Study Completion Date: August 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: iThermonitor; Participants are asked to use the iThermonitor device for two weeks to monitor their temperature. Participants are asked to wear the device for as many hours as they can but at a minimum to wear while sleeping.	Device: iThermonitor; The device is a continuous temperature monitoring tool for home monitoring of temperature. Participants are asked to use this device for two weeks.

Outcome Measures

Primary Outcome Measures :

1. Percent of Participants That Successfully Used the iThermonitor [ Time Frame: Two Weeks ]
   This will be assessed by ability of the device to successfully capture, transmit and display the patient's body temperature data on the study iPod TouchiPad mini. To limit recall bias, subjects will be required to log the ability to view the temperature data on the iPad mini once a day for the entire duration of the study. The device will be deemed a feasible continuous temperature monitoring tool if at least 80% of study subjects are able to successfully use the iThermonitor to monitor their body temperature. A subject must be able to view temperature data on the provided iPad mini at least 80% of the time in the study to be considered successful. "Time in the study" here is defined as the number of days the subject spends in the study which is expected to be two weeks.

Secondary Outcome Measures :

1. Care Giver Anxiety [ Time Frame: 0 & 2 weeks ]
   The Generalized Anxiety Disorder, 7 item questionnaire was given to caregivers to see if using the device increased feelings of anxiety. This will be assessed using the GAD-7 questionnaire administered at enrollment and closeout
2. Usability, Acceptability and Satisfaction [ Time Frame: 2 weeks ]
   This will be assessed by questionnaires specifically designed for this study. We will be assessing ease of use, acceptability, connection and use problems like the device falling off the skin, usefulness of out-of-range temperature alerts and adverse reactions. We will also assess to see if the device helps to build caregiver self-efficacy skills in caring for the patient.

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Dyad consists of a pediatric patient aged 2-17 years undergoing myelosuppressive therapies for acute leukemias and other childhood cancers.
• Dyad also includes a caregiver, ≥ 18 years of age that is willing to participate in the study.
• Ability of caregiver or patient (if old enough) to read and speak English.
• If applicable, willingness of the patient to shave axillary (armpit) hair.
• Caregiver (parent or legal guardian) must give informed consent for dyad participation.

Exclusion Criteria:

• Patient has a history of allergy to hydrogel dressing or ongoing skin diseases
• Patients with ongoing febrile illness or documented infectious disease.

Contacts and Locations

Locations

United States, Massachusetts

Amanda Centi

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Dana-Farber Cancer Institute

Investigators

• Principal Investigator: Stephen Agboola, MD, MPH; Partners Connected Health Innovations

  Study Documents (Full-Text)

Documents provided by Joseph C. Kvedar, Massachusetts General Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] June 15, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kakarmath SS, de Redon E, Centi AJ, Palacholla R, Kvedar J, Jethwani K, Agboola S. Assessing the Usability of an Automated Continuous Temperature Monitoring Device (iThermonitor) in Pediatric Patients: Non-Randomized Pilot Study. JMIR Pediatr Parent. 2018 Dec 21;1(2):e10804. doi: 10.2196/10804.

• Responsible Party: Joseph C. Kvedar, Dermatologist, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02410252
• Other Study ID Numbers: 14-485
• First Posted: April 7, 2015
• Results First Posted: July 31, 2018
• Last Update Posted: October 22, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to share IPD.

Keywords provided by Joseph C. Kvedar, Massachusetts General Hospital:

continuous temperature monitoring; patient self-management; iThermonitor; Home monitoring

Additional relevant MeSH terms:

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid