Remote Monitoring for Pediatric Heart Disease

Overseen By Rae Foshaug

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Physical impairment, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

23 Participants Needed

Trial Summary

What is the purpose of this trial?

Infants and children with heart conditions require treatment in children's hospitals that are typically located in large cities. This creates challenges for children and families who need to travel long distances to come to appointments. Providing quality care to children with heart disease has further been challenged by the COVID-19 pandemic, with a shift towards decreased in-person contact and an increase in virtual visits, where assessment by doctors and nurses is more limited. This research study will look at how families of children with heart disease access care and how investigators can improve care with virtual technologies. This will involve testing a new home-based virtual care platform that uses Bluetooth technology to connect weight scales, oxygen measuring devices and blood pressure cuffs with a smartphone app, allowing parents to easily use these devices and send accurate data directly to the cardiology team. Investigators will obtain feedback from families, patients, and healthcare providers about how this helped or did not help them, and adjust the technology as needed to make it better.

Research Team

Jennifer Conway, MD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for English-speaking children with heart conditions who are patients at Stollery Children's Hospital. It includes infants under 12 months with certain heart diseases and kids aged 5-17 with heart failure or post-heart transplant. Participants need internet access and a caregiver able to use technology.

Inclusion Criteria

This criterion is not written in a way that can be simplified. It seems to be a specific reference to patients at a particular hospital and department, which may not be suitable for a general, plain language summary.

I am aged 5-17 with heart failure, listed for a transplant, or had one within the last year.

Access to internet either in the household or within the community

Exclusion Criteria

I am not fluent in English, which may limit my participation in interviews.

My caregiver cannot use technology because of physical or mental reasons.

No access to the internet (thus unable to transmit the device data through the app or be able to complete the qualitative interview)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Remote Physiological Monitoring

Participants use a home-based virtual care platform with Bluetooth technology to monitor physiological parameters and send data to the cardiology team.

3 weeks

Virtual monitoring with remote data submission

Feedback and Analysis

Qualitative interviews with families, participants, and healthcare providers to gather feedback on the technology and app.

3 weeks

Virtual interviews

Follow-up

Participants are monitored for safety and effectiveness after the initial monitoring phase.

4 weeks

Treatment Details

Interventions

• Virtual Remote Physiological Monitoring Program

Trial Overview The study tests a home-based virtual care platform connecting scales, oxygen devices, and blood pressure cuffs via Bluetooth to an app. This allows data sharing directly with the cardiology team, aiming to improve care for children with heart disease through remote monitoring.

Participant Groups

Group I: Remote physiological monitoring Experimental Treatment 1 Intervention

Patients will be recruited from inpatient and outpatient cardiology service at the Stollery Children's Hospital will be purposively selected, with 50% of the patients living at least 100km from the Stollery into one of the following groups: Group 1: Infants \<12 months of age with single ventricle physiology or biventricular cyanotic congenital heart disease. Group 2: Patients aged 5-17 with heart failure, listed for transplant, or within 1 year of transplant.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+