Trials / Terminated
TerminatedNCT06547268
Advancing the Science of Pediatric Interstage Home Monitoring
Heart@Home: Advancing the Science of Pediatric Interstage Home Monitoring
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 2 (actual)
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Wireless sensor and platform | Skin-mounted sensor that pairs with tablet platform |
Timeline
- Start date
- 2024-07-24
- Primary completion
- 2025-10-30
- Completion
- 2025-10-30
- First posted
- 2024-08-09
- Last updated
- 2025-10-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06547268. Inclusion in this directory is not an endorsement.