WIReD: Wireless Interstage Remote Device Study

Pediatrics Clinical Trial

— WIReD  

Official title:

WIReD: Wireless Interstage Remote Device Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05975658
• Other study ID #: STUDY00002554
• Status: Enrolling by invitation
• Start date: September 30, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: November 1, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases
• Pediatrics
• Remote Monitoring
• Vital Signs

Intervention

Device:
• Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, Gabi Analytics]
Gabi SmartCare has created a monitoring system named Pediarity System that obtains pediatric vitals data through non-invasive means through a Gabi band. When paired with a proprietary algorithm and software - Gabi Analytics - the cloud-based platform measures blood oxygen levels, pulse rate (and variability), respiratory rate, actigraphy, inter-beat interval, and tracking for the time the device is worn (or not worn by the child). Three LEDs on the monitor are used for capturing this information. Peak wavelengths for the red, infrared, and green LEDs operate at 660nm, 950nm, and 526nm respectively. The Gabi band features an optical front end coupled with an analog front end using 24 bits. Bluetooth data transmission is utilized on a mobile phone application with a tablet-based system in a CSV format for the purpose of offline data processing.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	Gabi SmartCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental Experience Evaluation	Rigorously explore the parental experience of utilizing a continuous pediatric wireless device for monitoring at home pulse oximetry compared with standard of care periodic pulse oximetry through parent interviews.	3-6 Weeks
Secondary	Data Transfer Rate Evaluation	Evaluate the rate of data transfer from a wireless continuous monitoring device night ± daytime vs. standard of care periodic pulse oximetry.	3-6 Weeks
Secondary	Stakeholder Experience Assessment	Assess the technology experience for stakeholders with a wireless continuous monitoring device at home vs. standard of care periodic pulse oximetry using healthcare provider interviews to discuss outcome experience.	3-6 Weeks
Secondary	Data Threshold Event Rate Evaluation	Evaluate the rate of data threshold events with continuous remote device monitoring at home vs. intermittent pulse oximetry via standard of care periodic pulse oximetry.	3-6 Weeks
Secondary	Satisfaction with the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Secondary	Effectiveness with the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Secondary	Comfort with the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Secondary	Easy to use the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Secondary	Easy to find information within the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Secondary	Visualization of information within the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Secondary	Clear organization of information within the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Secondary	Functions of the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks

External Links

•   Gabi SmartCare Website