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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of technology
Secondary outcome measures
Device and app feedback
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.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,118 Total Patients Enrolled
Jennifer Conway, MDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am not fluent in English, which may limit my participation in interviews.My caregiver cannot use technology because of physical or mental reasons.My child is under 1 year old with a specific heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Remote physiological monitoring
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently being enrolled for this research?
"Confirmed. Clinicaltrials.gov has noted that this medical trial is recruiting, having been posted on February 8th 2022 and updated a fortnight later on the 23rd of February."
Answered by AI
What is the current enrollment figure for this analysis?
"Confirmed. The information hosted on clinicaltrials.gov states that the trial was first posted on February 8th 2022 and is actively looking for 20 test subjects at one medical centre."
Answered by AI
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