Advancing the Science of Pediatric Interstage Home Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-24

Study Completion Date

2025-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Defects, Congenital

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Wireless sensor and platform

Intervention Type DEVICE

Skin-mounted sensor that pairs with tablet platform

Interventions

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Wireless sensor and platform

Skin-mounted sensor that pairs with tablet platform

Intervention Type DEVICE

Other Intervention Names

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Arc

Eligibility Criteria

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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.

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No