Clinical trial NCT06547268: Advancing the Science of Pediatric Interstage Home Monitoring
Official title: Heart@Home: Advancing the Science of Pediatric Interstage Home Monitoring
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Defects, Congenital
Keywords: Heart Defects, Congenital
Digital Health
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Sibel Health Inc.
First posted: 2024-08-09
Enrollment: 20
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children receiving remote patient monitoring in tele-interstage home monitoring program.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physiologic measurements
timeFrame: up to 14 days per patient of data collection
Secondary outcomes:
measure: Systems Usability Score
timeFrame: up to 14 days per patient of data collection
measure: Utilization
timeFrame: up to 14 days per patient of data collection
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann and Robert H. Lurie Children&#39;s Hospital of Chicago
name: Carolyn C Foster, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.