Advancing the Science of Pediatric Interstage Home Monitoring

Ann & Robert H Lurie Children's Hospital of Chicago2 enrolled

Overview

The overall goal of this study is to understand the feasibility of using a wireless sensor device (instead of a wired device) to collect information used to monitor children with heart conditions at home.

The goal of this study is to examine how well continuous sensor-based monitoring performs at detecting physiologic data in infants with single ventricle physiology at home compared to existing approaches, in manner that is feasible and acceptable to patients' families. Performance features of interest include how the data compares to family measurements, whether it correlates with parents' observable symptoms, and how this approach may be integrated into home life and health system workflows. The investigators will also explore whether the collected data can be used to develop predictive analytics for acute deterioration and/or advanced chronic cardiopulmonary management compared to what is currently being done in remote patient monitoring.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Defects, Congenital

Interventions

Wireless sensor and platformDEVICE

Skin-mounted sensor that pairs with tablet platform

Eligibility

Sex: ALLMax age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Receiving active remote patient monitoring (RPM) in Lurie's Tele-Interstage Home Monitoring Program. * Age 0-2 years of age at enrollment. * In the opinion of the investigator, parent or legally authorized guardian, and participant, the participant and (when relevant) family can follow study procedures. Exclusion Criteria: * Is going to discontinue RPM before their enrollment would end (i.e., within 14 days). * Skin breakdown or severe rash at the site of sensor placement. * Patient without a parental guardian to consent. * The patient is in active hospice or similar end-of-life care. * The patient will be living in a long-term institution or transitional facility.

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Physiologic measurements

Physiologic data waveform morphology

Time frame: up to 14 days per patient of data collection

Secondary Outcomes

Systems Usability Score

Score from 0 (min) to 100 (max) of usability with higher is better (100=perfect).

Time frame: up to 14 days per patient of data collection

Utilization

Emergency departnment use

Time frame: up to 14 days per patient of data collection

Data from ClinicalTrials.gov

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