Clinical trial NCT05034354: Virtual Remote Physiological Monitoring Program of Children With Heart Disease
Official title: Development and Feasibility of a Virtual Remote Physiological Monitoring Program of Children With Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric ALL
Congenital Heart Disease
Single-ventricle
Biventricular Congestive Heart Failure
Heart Failure
Heart Failure，Congestive
Transplant; Failure, Heart
Keywords: Remote physiological monitoring
Qualitative interviews
Perceptions of virtual care
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 23
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective multi-methods observational study
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acceptability of technology
timeFrame: 3-weeks
Secondary outcomes:
measure: Device and app feedback
timeFrame: 3-weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jennifer Conway, MD
role: PRINCIPAL_INVESTIGATOR
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