Pediatrics Clinical Trial
— WIReDOfficial title:
WIReD: Wireless Interstage Remote Device Study
Verified date | June 2024 |
Source | Children's Mercy Hospital Kansas City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Hospital | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City | Gabi SmartCare |
United States,
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 |
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