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Virtual Remote Physiological Monitoring Program of Children With Heart Disease

Primary Purpose

Pediatric ALL, Congenital Heart Disease, Single-ventricle

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Remote physiological monitoring
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Pediatric ALL focused on measuring Remote physiological monitoring, Qualitative interviews, Perceptions of virtual care

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remote physiological monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Device and app feedback
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.

Full Information

First Posted
August 27, 2021
Last Updated
February 24, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05034354
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective multi-methods observational study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote physiological monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Remote physiological monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of technology
Description
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.
Time Frame
3-weeks
Secondary Outcome Measure Information:
Title
Device and app feedback
Description
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.
Time Frame
3-weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rae Foshaug
Phone
780-407-7499
Email
raef@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Conway, MD
Phone
780-407-3952
Email
jennifer.conway2@albertahealthservices.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Conway, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rae Foshaug
Phone
780-407-7499
Email
rae.foshaug@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Jennifer Conway, MD
Email
jennifer.conway2@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Jennifer Conway, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33931237
Citation
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.
Results Reference
background
PubMed Identifier
33946011
Citation
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.
Results Reference
background
PubMed Identifier
33340672
Citation
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.
Results Reference
background
PubMed Identifier
30570200
Citation
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.
Results Reference
background
PubMed Identifier
23337893
Citation
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.
Results Reference
background
PubMed Identifier
23663957
Citation
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.
Results Reference
background
PubMed Identifier
27554255
Citation
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. Erratum In: Pediatr Cardiol. 2017 Jan 19;:
Results Reference
background
PubMed Identifier
22914224
Citation
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.
Results Reference
background
PubMed Identifier
33532544
Citation
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.
Results Reference
background

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Virtual Remote Physiological Monitoring Program of Children With Heart Disease

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