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Virtual Remote Physiological Monitoring Program of Children With Heart Disease

NCT05034354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Pediatric ALL
  • Congenital Heart Disease
  • Single-ventricle
  • Biventricular Congestive Heart Failure
  • Heart Failure
  • Heart Failure，Congestive
  • Transplant; Failure, Heart

Interventions

DEVICE

Remote physiological monitoring

Participants will be provided with a Bluetooth capable weight scale (A\&D Medical UC-352BLE or Beurer BY90), oxygen saturation monitor (Contec Medical Systems CMS50D-BT) and automatic blood pressure monitor (A\&D Medical UA- 651BLE) to use daily for at least 10 days of a 14-day trial period. Data will be sent via the Sphygmo App to the pediatric cardiology for monitoring. Parents and healthcare providers will be asked to participate in a qualitative interview and the end of the 14-day period to provide feedback on the devices and Sphygmo™ platform.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Jennifer Conway, MD · University of Alberta

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2024-09-30
Completion
2025-01-10

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05034354 on ClinicalTrials.gov