Advancing the Science of Pediatric Interstage Home Monitoring

NCT06547268 | Terminated FDA Device

• 1 other identifier: 2023-6397
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital

Keywords

Heart Defects, Congenital; Digital Health

Outcome Measures

Primary Outcomes (1)

• Physiologic measurements

  Physiologic data waveform morphology

  up to 14 days per patient of data collection

Secondary Outcomes (2)

• Systems Usability Score

  up to 14 days per patient of data collection

• Utilization

  up to 14 days per patient of data collection

Study Arms (1)

Home monitoring program patients

Patients enrolled in the study are those patients who are already enrolled in (or are being discharged with) home monitoring in an existing program

Device: Wireless sensor and platform

Interventions

Wireless sensor and platform DEVICE

Skin-mounted sensor that pairs with tablet platform

Also known as: Arc

Home monitoring program patients

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children receiving remote patient monitoring in tele-interstage home monitoring program.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Sibel Health Inc.: collaborator

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• Foster C, Schinasi D, Kan K, Macy M, Wheeler D, Curfman A. Remote Monitoring of Patient- and Family-Generated Health Data in Pediatrics. Pediatrics. 2022 Feb 1;149(2):e2021054137. doi: 10.1542/peds.2021-054137.

  PMID: 35102417 BACKGROUND

• Foster CC, Steltzer M, Snyder A, Alden C, Helner K, Schinasi DA, Bohling K, Allen K. Integrated Multimodality Telemedicine to Enhance In-Home Care of Infants During the Interstage Period. Pediatr Cardiol. 2021 Feb;42(2):349-360. doi: 10.1007/s00246-020-02489-7. Epub 2020 Oct 20.

  PMID: 33079264 BACKGROUND

• Rudd NA, Ghanayem NS, Hill GD, Lambert LM, Mussatto KA, Nieves JA, Robinson S, Shirali G, Steltzer MM, Uzark K, Pike NA; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Lifelong Congenital Heart Disease and Heart Health in the Young; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Clinical Cardiology; and Council on Lifestyle and Cardiometabolic Health. Interstage Home Monitoring for Infants With Single Ventricle Heart Disease: Education and Management: A Scientific Statement From the American Heart Association. J Am Heart Assoc. 2020 Aug 18;9(16):e014548. doi: 10.1161/JAHA.119.014548. Epub 2020 Aug 11.

  PMID: 32777961 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Carolyn C Foster, MD, MS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: July 24, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)