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

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

Ann & Robert H Lurie Children's Hospital of Chicago

Status

Enrolling

Conditions

Heart Defects, Congenital

Treatments

Device: Wireless sensor and platform

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06547268
2023-6397

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

Under 2 years old

Volunteers

No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Carolyn C Foster, MD, MS; Leah C Hoelscher, MD, MS

Data sourced from clinicaltrials.gov

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