Congenital Heart Disease in ChildrenWIReDNCT05975658
WIReD: Wireless Interstage Remote Device Study
An observational study of Congenital Heart Disease in Children and Vital Signs, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Congenital Heart Disease in Children, Vital Signs, Pediatrics
- What is being tested?
- Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, Gabi Analytics]
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2023to 3 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
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).
Read the 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.
- Being tested
- Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, Gabi Analytics]
- Keywords
- Pediatric, Physiologic vital signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, Gabi Analytics]Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 Weeks
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 3-6 Weeks
Satisfaction with the System
Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
Measured: 3-6 weeks
Effectiveness with the System
Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
Measured: 3-6 weeks
Comfort with the System
Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
Measured: 3-6 weeks
Easy to use the System
Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
Measured: 3-6 weeks
Easy to find information within the System
Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
Measured: 3-6 weeks
Visualization of information within the System
Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
Measured: 3-6 weeks
Clear organization of information within the System
Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
Measured: 3-6 weeks
Functions of the System
Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
Measured: 3-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start30 Sep 2023
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Gabi SmartCare
- Responsible party
- Principal investigator, Lori Erickson, Children's Mercy Hospital Kansas City
- Investigators
- Lori Erickson, PhD, Principal investigator, Director, Remote Health Solutions Children's Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975658
- Sponsor's protocol ID
- STUDY00002554
- Acronym
- WIReD
- Status last verified
- Dec 2024
- First submitted
- 27 Jul 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WIReD: Wireless Interstage Remote Device Study
- ClinicalTrials.gov ID
- NCT05975658
- Acronym / sponsor ID
- WIReD / STUDY00002554
- Keywords
- Pediatric, Physiologic vital signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Gabi SmartCare
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Parental Experience Evaluation
Time frame: 3-6 Weeks
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.
11 secondary outcomes
Data Transfer Rate Evaluation
Time frame: 3-6 Weeks
Stakeholder Experience Assessment
Time frame: 3-6 Weeks
Data Threshold Event Rate Evaluation
Time frame: 3-6 Weeks
Satisfaction with the System
Time frame: 3-6 weeks
Effectiveness with the System
Time frame: 3-6 weeks
Comfort with the System
Time frame: 3-6 weeks
Easy to use the System
Time frame: 3-6 weeks
Easy to find information within the System
Time frame: 3-6 weeks
Visualization of information within the System
Time frame: 3-6 weeks
Clear organization of information within the System
Time frame: 3-6 weeks
Functions of the System
Time frame: 3-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Gabi SmartCare WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Erickson, PhD principal investigator
Director, Remote Health Solutions Children's Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease in Children and Vital Signs, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Experience Evaluation (time frame: 3-6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.