Virtual Remote Physiological Monitoring Program of Children With Heart Disease

January 29, 2025 updated by: University of Alberta

Development and Feasibility of a Virtual Remote Physiological Monitoring Program of Children With Heart Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a prospective multi-methods observational study. Investigators will assess the feasibility of the novel home-based remote physiological monitoring (RPM) system paired to a smartphone app (Sphygmo™) and linked to a secure physician platform. The study team will enroll caregivers of medically high- risk infants with CHD and children and caregivers with heart failure or early post heart transplant. In addition, investigators will obtain feedback from their healthcare providers. Qualitative analysis of semi- structured interviews will determine patient and parent/caregiver and healthcare providers experience with the system and allow for future modifications specific to pediatrics.

Purposive sampling will be used to achieve a maximum variation and will ensure a diverse group of patients/caregivers that represent a variety of patient profiles. The study team aim to recruit 10 participants in each group, with 50% of the patients living at least 100 km drive from the Stollery.

Medical records will be accessed to collect baseline characteristics including date of birth, sex, postal code, diagnoses, surgeries and procedures. The number of pediatric cardiology clinic visits, hospitalizations, ED visits, and cardiac investigations in the last 2 years will be collected to describe the patients requirements for access to cardiac care. In addition, the family will be asked to complete a demographic form that compiles information about parents' ethnicity, education level, SES, access to Wi-FI and iOS/Android devices in the home.

An emerging, qualitative descriptive approach will be used to explore patient and parents' experiences using the RPM devices and app in their home as part of their daily care routine. Data collection and analysis will occur iteratively to allow emerging ideas. Semi-structured interviews with parents/patients/healthcare providers will be conducted by a qualitatively trained members of the study team. Data collection will occur until saturation (data redundancy) is achieved. Interviews will be held and recorded on a secure, password protected Zoom™ ECHO account and digitally captured and transcribed by Zoom auto-transcription services.

Baseline and demographic characteristics will be analyzed using descriptive statistics. Investigators will ascertain adherence with the protocol by determining the mean number of requested assessments performed and the proportion of patients who completed >80% of measurements. This will contribute to our understanding of the acceptability of this technology from the patient and family perspective.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of Pediatric Cardiology at the Stollery Children's Hospital in Edmonton, AB
  • Group 1: infants <12 months of age with single ventricle physiology or biventricular cyanotic congenital heart disease
  • Group 2: patients aged 5 to 17 years with heart failure, listed for heart transplant, or within 1-year of heart transplant
  • English speaking
  • Access to internet either in the household or within the community

Exclusion Criteria:

  • Inability to use technology due to physical or cognitive impairment in the caregiver
  • Non-English speaking (thus limiting communication during qualitative interviews)
  • No access to the internet (thus unable to transmit the device data through the app or be able to complete the qualitative interview)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote physiological monitoring

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of technology
Time Frame: 3-weeks
We will ascertain adherence with the protocol by determining the mean number of requested assessments performed and the proportion of participants who complete >80% of measurements. This will contribute to our understanding of the acceptability of this technology from the patient and family perspective.
3-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device and app feedback
Time Frame: 3-weeks
Families, participants if they are of age and understanding, and healthcare providers will provide feedback through qualitative interviews on the Bluetooth devices and Sphygmo application. As the app is designed for adults, this feedback will allow the study team to work with developers on a pediatric focused version of the application.
3-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Jennifer Conway, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2022

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00112366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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