Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547268
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Advancing the Science of Pediatric Interstage Home Monitoring
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HeartHome Advancing the Science of Pediatric Interstage Home Monitoring
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HeartHome
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 andor advanced chronic cardiopulmonary management compared to what is currently being done in remote patient monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None