WIReD: Wireless Interstage Remote Device Study (WIReD)

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).

Study Overview

• Status: Completed
• Conditions: Pediatrics; Congenital Heart Disease in Children; Vital Signs; Remote Monitoring
• Intervention / Treatment: Device: Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, 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.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Satisfaction with the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Effectiveness with the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Comfort with the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Easy to use the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Easy to find information within the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Visualization of information within the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Clear organization of information within the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks
Functions of the System	Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7	3-6 weeks

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: Gabi SmartCare
• Investigators: Principal Investigator: Lori Erickson, PhD, Director, Remote Health Solutions Children's Mercy

Publications and helpful links

Helpful Links

• Gabi SmartCare Website

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Actual): December 3, 2024
• Study Completion (Actual): December 3, 2024

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; Physiologic vital signs
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: STUDY00002554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No