Virtual Remote Physiological Monitoring Program of Children With Heart Disease

NCT05034354 | Completed

• 1 other identifier: Pro00112366
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Acceptability of technology

  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 Outcomes (1)

• Device and app feedback

  3-weeks

Study Arms (1)

Remote physiological monitoring

EXPERIMENTAL

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

Interventions

Remote physiological monitoring DEVICE

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.

Remote physiological monitoring

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (9)

• Lorch SA, Rogowski J, Profit J, Phibbs CS. Access to risk-appropriate hospital care and disparities in neonatal outcomes in racial/ethnic groups and rural-urban populations. Semin Perinatol. 2021 Jun;45(4):151409. doi: 10.1016/j.semperi.2021.151409. Epub 2021 Mar 21.

  PMID: 33931237 BACKGROUND

• Choi SA, Lim K, Baek H, Yoo S, Cho A, Kim H, Hwang H, Kim KJ. Impact of mobile health application on data collection and self-management of epilepsy. Epilepsy Behav. 2021 Jun;119:107982. doi: 10.1016/j.yebeh.2021.107982. Epub 2021 May 1.

  PMID: 33946011 BACKGROUND

• Padwal R, Wood PW. Digital Health Approaches for the Assessment and Optimisation of Hypertension Care Provision. Can J Cardiol. 2021 May;37(5):711-721. doi: 10.1016/j.cjca.2020.12.009. Epub 2020 Dec 17.

  PMID: 33340672 BACKGROUND

• Padwal RS, So H, Wood PW, Mcalister FA, Siddiqui M, Norris CM, Jeerakathil T, Stone J, Valaire S, Mann B, Boulanger P, Klarenbach SW. Cost-effectiveness of home blood pressure telemonitoring and case management in the secondary prevention of cerebrovascular disease in Canada. J Clin Hypertens (Greenwich). 2019 Feb;21(2):159-168. doi: 10.1111/jch.13459. Epub 2018 Dec 20.

  PMID: 30570200 BACKGROUND

• Hehir DA, Ghanayem NS. Single-ventricle infant home monitoring programs: outcomes and impact. Curr Opin Cardiol. 2013 Mar;28(2):97-102. doi: 10.1097/HCO.0b013e32835dceaf.

  PMID: 23337893 BACKGROUND

• Siehr SL, Norris JK, Bushnell JA, Ramamoorthy C, Reddy VM, Hanley FL, Wright GE. Home monitoring program reduces interstage mortality after the modified Norwood procedure. J Thorac Cardiovasc Surg. 2014 Feb;147(2):718-23.e1. doi: 10.1016/j.jtcvs.2013.04.006. Epub 2013 May 8.

  PMID: 23663957 BACKGROUND

• Castellanos DA, Herrington C, Adler S, Haas K, Ram Kumar S, Kung GC. Home Monitoring Program Reduces Mortality in High-Risk Sociodemographic Single-Ventricle Patients. Pediatr Cardiol. 2016 Dec;37(8):1575-1580. doi: 10.1007/s00246-016-1472-x. Epub 2016 Aug 23.

  PMID: 27554255 BACKGROUND

• Park KT, Bensen R, Lu B, Nanda P, Esquivel C, Cox K. Geographical rural status and health outcomes in pediatric liver transplantation: an analysis of 6 years of national United Network of Organ Sharing Data. J Pediatr. 2013 Feb;162(2):313-8.e1. doi: 10.1016/j.jpeds.2012.07.015. Epub 2012 Aug 20.

  PMID: 22914224 BACKGROUND

• Bertagnin E, Greco A, Bottaro G, Zappulla P, Romanazzi I, Russo MD, Lo Presti M, Valenti N, Sollano G, Calvi V. Remote monitoring for heart failure management during COVID-19 pandemic. Int J Cardiol Heart Vasc. 2021 Feb;32:100724. doi: 10.1016/j.ijcha.2021.100724. Epub 2021 Jan 28.

  PMID: 33532544 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Heart Defects, Congenital; Univentricular Heart; Heart Failure

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jennifer Conway, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multi-methods observational study

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 5, 2021
• Study Start: February 8, 2022
• Primary Completion: September 30, 2024
• Study Completion: January 10, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)