Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02410252
• Collaborator: Dana-Farber Cancer Institute (Other)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 0.9

Study Details

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	N/A

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
• 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 1, 2015
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Aug 1, 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 [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 [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 [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

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol and Statistical Analysis Plan - Jun 15, 2017

More Information

Publications

None provided.

• Responsible Party: Joseph C. Kvedar, Dermatologist, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02410252
• Other Study ID Numbers: 14-485
• First Posted: Apr 7, 2015
• Last Update Posted: Oct 22, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Joseph C. Kvedar, Dermatologist, Massachusetts General Hospital: continuous temperature monitoring; patient self-management; iThermonitor; Home monitoring
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

Participant Flow

Recruitment Details	Adolescent-Caregiver dyads were recruited from the MGH Pediatric Cancer Center or the MGH Hospital for Children (Surgical Division). Recruitment began in early 2015 and was completed by April of 2017.

Arm/Group Title	Temperature Monitoring Group
Arm/Group Description	This was a single arm usability and feasibility study. All participants were enrolled into the same group and used the temperature monitoring device for 2 weeks.
Period Title: Overall Study
STARTED	25
COMPLETED	19
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Temperature Monitoring Group
Arm/Group Description	This was a single arm usability and feasibility study. All participants were enrolled into the same group where they used the study device to monitor their temperature for two weeks.
Overall Participants	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8 (5)
Sex: Female, Male (Count of Participants)
Female	5 26.3%
Male	14 73.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	17 89.5%
More than one race	0 0%
Unknown or Not Reported	1 5.3%
Region of Enrollment (participants) [Number]
United States	19 100%
Age of Caregivers (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (8)
Employment Status of Caregivers (Count of Participants)
Employed, full time	5 26.3%
Employed, part time	3 15.8%
Homemaker	6 31.6%
Unemployed	5 26.3%

Outcome Measures

1. Primary Outcome

Title	Percent of Participants That Successfully Used the iThermonitor
Description	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.
Time Frame	Two Weeks

Outcome Measure Data

Analysis Population Description

Caregivers of participants using the device

Arm/Group Title	Temperature Monitoring Group
Arm/Group Description	This was a single arm usability and feasibility study. All participants were enrolled into the same group and monitored their body temperature using the study device for 2 weeks.
Measure Participants	19
View data at least once per day	100 526.3%
Reported receiving out of range alerts	75 394.7%
Reported receiving 3 or more out of range alerts	63 331.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Temperature Monitoring Group
	Comments	Descriptive statistics were used to characterize the study sample, and survey responses.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	%
	Estimated Value	100
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Temperature Monitoring Group
	Comments	Only percent will be calculated. No statistical analysis will be conducted.
	Type of Statistical Test	Other
	Comments	Only percents were calculated, no formal statistical analysis was completed.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		No statistical analysis was conducted as part of this study.

2. Secondary Outcome

Title	Care Giver Anxiety
Description	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
Time Frame	0 & 2 weeks

Outcome Measure Data

Analysis Population Description

Caregivers of participants using the device.

Arm/Group Title	Temperature Monitoring Group
Arm/Group Description	This was a single arm usability and feasibility study. All participants were enrolled into the same group and used the study device to monitor body temperature for 2 weeks.
Measure Participants	19
No anxiety	12 63.2%
Mild anxiety	3 15.8%
Moderate anxiety	1 5.3%
Severe anxiety	3 15.8%
No anxiety	16 84.2%
Mild anxiety	2 10.5%
Moderate anxiety	0 0%
Severe anxiety	1 5.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Temperature Monitoring Group
	Comments	GAD-7 scores were coded as a categorical variable as follows: mild anxiety (total score 0 to 5) and moderate/ severe anxiety (total score 6-15). Proportion of participants with mild and moderate/ severe anxiety at enrollment and closeout was compared using Cochran's Q test.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments	Significance was set at p<0.05
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	%
	Estimated Value	0.29
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Usability, Acceptability and Satisfaction
Description	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.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Caregivers of participants using the device.

Arm/Group Title	Temperature Monitoring Group
Arm/Group Description	This was a single arm usability and feasibility study. All participants were enrolled into the same group and asked to monitor their body temperature for 2 weeks using the study device.
Measure Participants	19
Definitey True	8 42.1%
Mostly True	9 47.4%
A little true	0 0%
Not true	2 10.5%
Definitey True	13 68.4%
Mostly True	6 31.6%
A little true	0 0%
Not true	0 0%
Definitey True	13 68.4%
Mostly True	3 15.8%
A little true	1 5.3%
Not true	1 5.3%
Definitey True	12 63.2%
Mostly True	3 15.8%
A little true	2 10.5%
Not true	2 10.5%
Definitey True	10 52.6%
Mostly True	4 21.1%
A little true	2 10.5%
Not true	2 10.5%
Definitey True	5 26.3%
Mostly True	2 10.5%
A little true	5 26.3%
Not true	5 26.3%
Definitey True	2 10.5%
Mostly True	7 36.8%
A little true	4 21.1%
Not true	6 31.6%
Definitey True	10 52.6%
Mostly True	5 26.3%
A little true	2 10.5%
Not true	2 10.5%
Definitey True	10 52.6%
Mostly True	4 21.1%
A little true	4 21.1%
Not true	1 5.3%
Definitey True	5 26.3%
Mostly True	5 26.3%
A little true	5 26.3%
Not true	4 21.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Temperature Monitoring Group
	Comments	Descriptive statistics were used to characterize the study sample, and survey responses. All analysis was conducted using STATA version 14.2 with an alpha of 0.05 set a priori. Since this was an exploratory study with descriptive statistics, a complete case analysis approach was adopted for this study
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	descriptive analysis
	Comments
Method of Estimation	Estimation Parameter	%
	Estimated Value	84
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse event information was collected during active enrollment in the study and reported annually to the IRB (over 3 years).
Arm/Group Title	Temperature Monitoring Group
Arm/Group Description	Single group subjects that will use the iThermonitor device to collect temperature information for two weeks. iThermonitor: The device is a continuous temperature monitoring tool for home monitoring of temperature
All Cause Mortality
	Temperature Monitoring Group
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Serious Adverse Events
	Temperature Monitoring Group
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	Temperature Monitoring Group
	Affected / at Risk (%)	# Events
Total	0/25 (0%)

Limitations/Caveats

One major limitation of our study is the lack of a control group that used another temperature measurement device such as a digital thermometer without a companion app or automated temperature measurement features.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.