Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies

NCT02410252 | Completed Results

• 1 other identifier: 14-485
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphocytic Leukemia; Acute Myeloid Leukemia; Non-Hodgkin Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent of Participants That Successfully Used the iThermonitor

  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.

  Two Weeks

Secondary Outcomes (2)

• Care Giver Anxiety

  0 & 2 weeks

• Usability, Acceptability and Satisfaction

  2 weeks

Study Arms (1)

iThermonitor

EXPERIMENTAL

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

Interventions

iThermonitor DEVICE

The device is a continuous temperature monitoring tool for home monitoring of temperature. Participants are asked to use this device for two weeks.

iThermonitor

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Amanda Centi

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 31518304 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Lymphoma

Limitations and 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.

Results Point of Contact

• Title: Amanda Centi
• Organization: Partners Connected Health Innovations

acenti@partners.org

6177242158

Study Officials

• Stephen Agboola, MD, MPH

  Partners Connected Health Innovations

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 7, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 22, 2020
• Results First Posted: July 31, 2018

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)