Clinical trial NCT05975658: WIReD: Wireless Interstage Remote Device Study
Official title: WIReD: Wireless Interstage Remote Device Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease in Children
Vital Signs
Pediatrics
Remote Monitoring
Keywords: Pediatric
Physiologic vital signs
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Gabi SmartCare
First posted: 2023-08-04
Enrollment: 13
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Maximum of 15 infants in the congenital, arrhythmic, or acquired heart disease population to be enrolled at Children's Mercy Hospital Kansas City.

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 Pediarity System. This system includes the Gabi Band and software platform (Gabi Analytics).

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 transfer. This education by the study team will ensure uniform training and preliminary understanding with teach back on the use of the Gabi band and Gabi Wi-Fi monitoring application. Parents can ask the study team any use and/or technical questions during this time period. All clinical care questions from standard of care monitoring will go to the CHAMP healthcare team. If parents/LARs have a clinical concern from a value on the Pediarity System - they will be referred to use their standard of care pulse oximetry before any clinical intervention and care is recommended by the healthcare team. The study team will not make any healthcare or diagnostic recommendations during the monitoring period based on any Pediarity System data.

The study team will educate parents and LARs on the Pediarity System. This system does not replace any use of their standard of care pulse oximetry and CHAMP videos. Parents may place the Gabi band on their child and use the Pediarity System at any frequency they choose in the home setting for a length of approximately one month at home (to coordinate when they return to the study site for a care visit). Parents can email or Teams call the study team directly (during daytime hours M-F) for any technical questions during this the study period. The study team will evaluate clinical data only at the conclusion of the study period and qualitative feedback from the parents will be gathered.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Parental Experience Evaluation
timeFrame: 3-6 Weeks
Secondary outcomes:
measure: Data Transfer Rate Evaluation
timeFrame: 3-6 Weeks
measure: Stakeholder Experience Assessment
timeFrame: 3-6 Weeks
measure: Data Threshold Event Rate Evaluation
timeFrame: 3-6 Weeks
measure: Satisfaction with the System
timeFrame: 3-6 weeks
measure: Effectiveness with the System
timeFrame: 3-6 weeks
measure: Comfort with the System
timeFrame: 3-6 weeks
measure: Easy to use the System
timeFrame: 3-6 weeks
measure: Easy to find information within the System
timeFrame: 3-6 weeks
measure: Visualization of information within the System
timeFrame: 3-6 weeks
measure: Clear organization of information within the System
timeFrame: 3-6 weeks
measure: Functions of the System
timeFrame: 3-6 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Director, Remote Health Solutions Children's Mercy
name: Lori Erickson, PhD
role: PRINCIPAL_INVESTIGATOR
References: