Advancing the Science of Pediatric Interstage Home Monitoring (Heart@Home)

October 30, 2025 updated by: Carolyn Foster, Ann & Robert H Lurie Children's Hospital of Chicago

Heart@Home: Advancing the Science of Pediatric Interstage Home Monitoring

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Skin-mounted sensor that pairs with tablet platform
Other Names:
  • Arc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiologic measurements
Time Frame: up to 14 days per patient of data collection
Physiologic data waveform morphology
up to 14 days per patient of data collection

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

Sibel Health Inc.

Investigators

  • Principal Investigator: Carolyn C Foster, MD, MS, Ann and Robert H. Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2024

Primary Completion (Actual)

October 30, 2025

Study Completion (Actual)

October 30, 2025

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 31, 2025

Last Update Submitted That Met QC Criteria

October 30, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-6397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data requests will be reviewed by PI if the occur.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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