Heart Defects, Congenital
Conditions
Keywords
Heart Defects, Congenital, Digital Health
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.
Interventions
DEVICEWireless sensor and platform
Skin-mounted sensor that pairs with tablet platform
Sponsors
Sibel Health Inc.
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiologic measurements | up to 14 days per patient of data collection | Physiologic data waveform morphology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systems Usability Score | up to 14 days per patient of data collection | Score from 0 (min) to 100 (max) of usability with higher is better (100=perfect). |
| Utilization | up to 14 days per patient of data collection | Emergency departnment use |
Countries
United States
Outcome results
None listed