Advancing the Science of Pediatric Interstage Home Monitoring

Active, not recruiting

• Conditions: Heart Defects, Congenital
• Interventions: Device: Wireless sensor and platform

• Registration Number: NCT06547268
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2024-07-24
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Home monitoring program patients	Wireless sensor and platform	Patients enrolled in the study are those patients who are already enrolled in (or are being discharged with) home monitoring in an existing program

Primary Outcome Measures

Name	Time	Method
Physiologic measurements	up to 14 days per patient of data collection	Physiologic data waveform morphology

Secondary Outcome Measures

Name	Time	Method
Systems Usability Score	up to 14 days per patient of data collection	Score from 0 (min) to 100 (max) of usability with higher is better (100=perfect).
Utilization	up to 14 days per patient of data collection	Emergency departnment use

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States