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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to enhance care for families of children with heart disease by testing a new virtual care platform, the Virtual Remote Physiological Monitoring Program. This program uses Bluetooth devices, such as weight scales and oxygen monitors, to send health data directly to doctors through a smartphone app. The trial will gather feedback from families, patients, and healthcare providers to refine the technology. It is suitable for infants under 12 months with certain heart conditions or children aged 5-17 dealing with heart failure or a heart transplant, who also have internet access at home or nearby. As an unphased trial, this study offers families the opportunity to contribute to innovative care solutions and improve future healthcare experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on using technology to monitor heart conditions rather than changing medication routines.

What prior data suggests that this virtual remote physiological monitoring program is safe for pediatric heart disease patients?

Studies have shown that virtual remote monitoring programs for children with heart conditions are generally safe. In one pilot project, researchers used Bluetooth devices like weight scales and oxygen monitors to collect health data from children. This method proved both safe and easy for families to use. Another review of telehealth solutions for heart disease found that these technologies are usually well-tolerated, with very few side effects reported. This allows children and parents to feel comfortable using these tools at home. Overall, initial findings suggest that such virtual care platforms are safe and can effectively manage heart health from a distance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Remote Monitoring for Pediatric Heart Disease trial because it uses a virtual remote physiological monitoring program to keep tabs on young heart patients from afar. Unlike traditional methods that require frequent hospital visits for monitoring, this approach allows doctors to track a child's heart health remotely. This is especially beneficial for families living far from specialized care centers, as it reduces travel and hospital time. By offering a convenient and continuous way to monitor heart conditions, this program aims to catch potential issues earlier and improve overall patient outcomes.

What evidence suggests that this virtual remote physiological monitoring program is effective for pediatric heart disease?

Research has shown that home-based virtual care can effectively manage children's heart conditions. In this trial, participants will enroll in a Remote Physiological Monitoring Program. One study found that Bluetooth technology, which connects medical devices with a smartphone app, allows families to easily share important health information with their child's heart doctor. This method benefits families living far from specialized hospitals by facilitating access to care. Additionally, past patients with heart disease demonstrated that remote monitoring is safe and useful. While it might not immediately reduce hospital visits, it helps doctors closely monitor symptoms and adjust treatments as needed. ^{1 3 4 6 7}

Who Is on the Research Team?

Jennifer Conway, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05034354

Virtual Remote Physiological Monitoring Program of ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12131034/

Interactive Telehealth Solutions for Patients With ... This systematic review investigates interactive telehealth solutions including application program interfaces for children and adults with CHD.

3. withpower.com withpower.com/trial/phase-univentricular-heart-8-2021-d58e2

Remote Monitoring for Pediatric Heart Disease Participants use a home-based virtual care platform with Bluetooth technology to monitor physiological parameters and send data to the cardiology team.

4. publications.aap.org publications.aap.org/pediatricsopenscience/article/1/2/1/201448/Feasibility-Safety-and-Efficacy-of-Pediatric

Feasibility, Safety, and Efficacy of Pediatric Cardiac ... This randomized controlled trial of pediatric participants with heart disease demonstrated that pediatric cardiac telerehabilitation is feasible ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2023.04.010

Remote Monitoring for Heart Failure Management at Home Early telemonitoring of weights and symptoms did not decrease heart failure hospitalizations but helped identify steps toward effective monitoring programs.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772812925000430

Capturing Physiological Data in Children With Heart ... We conducted a proof-of-concept pilot project to evaluate the feasibility of collecting and describing physiologic and activity data from pediatric patients ...

7. publications.aap.org publications.aap.org/pediatrics/article/149/2/e2021054137/184460/Remote-Monitoring-of-Patient-and-Family-Generated

Remote Monitoring of Patient- and Family-Generated ... In this article, we provide an overview of remote monitoring of pediatric PGHD and family-generated health data, including its current uses, ...