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Remote Monitoring for Pediatric Heart Disease

N/A

Recruiting

Led By Jennifer Conway, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Group 2: patients aged 5 to 17 years with heart failure, listed for heart transplant, or within 1-year of heart transplant

Group 1: infants <12 months of age with single ventricle physiology or biventricular cyanotic congenital heart disease

Must not have

Inability to use technology due to physical or cognitive impairment in the caregiver

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand how to better provide care for infants and children with heart conditions using virtual technologies.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive remote monitoring tools rather than medication, traditional side effects aren't expected. However, there may be technical issues or stress related to using new technologies that could affect families.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My child is under 1 year old with a specific heart condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of technology

Secondary study objectives

Device and app feedback

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Remote physiological monitoringExperimental Treatment1 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.

0 / 3Eligibility criteria met