Status:
COMPLETED
WIReD: Wireless Interstage Remote Device Study
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
Gabi SmartCare
Conditions:
Congenital Heart Disease in Children
Vital Signs
Eligibility:
All Genders
Up to 2 years
Brief Summary
A mixed-methods study will be used to evaluate the use of standard of care periodic pulse oximetry by parents/LAR and the feasibility of the collection of physiologic data related to the use of the Pe...
Detailed Description
After enrollment, parents will be taught by the study team on the use of the Pediarity System which includes the placement of the Gabi Band and the use of the Gabi Wi-Fi monitor application for data t...
Eligibility Criteria
Inclusion
- Study participants will be parent-child dyads - pediatric patients who have been diagnosed with congenital, arrhythmic, or acquired heart disease at Children's Mercy Kansas City.
- Age criteria for children: after birth and who are less than two years of age at the time of being approached.
- The child of the parent-child dyad must be planned from the clinical standpoint prior to approach for discharge home with standard of care oxygen saturation/heart rate/pulse oximeter for remote patient monitoring population - and followed with the CHAMP application in the home setting.
- CHAMP App CM IRB 15030113 - Pediatric patients may be followed by the CHAMP Clinical team or enrolled in the CHAMP App Cardiac Study
Exclusion
- Over two years of age at the time of being approached for study participation.
- Families that do not speak English or Spanish (languages supported by the devices).
- Families that do not have access to a Wi-Fi network at home.
Key Trial Info
Start Date :
September 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 3 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05975658
Start Date
September 30 2023
End Date
December 3 2024
Last Update
December 5 2024
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108