Pediatric ALLNCT05034354
Virtual Remote Physiological Monitoring Program of Children With Heart Disease
A study testing Remote physiological monitoring in people with Pediatric ALL and Congenital Heart Disease, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pediatric ALL, Congenital Heart Disease, Single-ventricle
- What is being tested?
- Remote physiological monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 8 Feb 2022to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric ALL, Congenital Heart Disease, Single-ventricle, Biventricular Congestive Heart Failure, Heart Failure, Heart Failure，Congestive
- Being tested
- Remote physiological monitoring
- Keywords
- Remote physiological monitoring, Qualitative interviews, Perceptions of virtual care
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Heart Defects, Congenital, Univentricular Heart, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote physiological monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Remote physiological monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-weeks
Secondary outcomes (1)
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.
Measured: 3-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start8 Feb 2022
- Primary completion30 Sep 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective multi-methods observational study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Conway, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034354
- Sponsor's protocol ID
- Pro00112366
- Status last verified
- Jan 2025
- First submitted
- 27 Aug 2021
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33931237Choi 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.
PubMed 33946011Padwal 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.
PubMed 33340672Padwal 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.
PubMed 30570200Hehir 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.
PubMed 23337893Siehr 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.
PubMed 23663957Castellanos 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.
PubMed 27554255Park 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.
PubMed 22914224Bertagnin 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.
PubMed 33532544
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility of a Virtual Remote Physiological Monitoring Program of Children With Heart Disease
- ClinicalTrials.gov ID
- NCT05034354
- Acronym / sponsor ID
- Pro00112366
- Conditions
- Pediatric ALL, Congenital Heart Disease, Single-ventricle, Biventricular Congestive Heart Failure, Heart Failure, Heart Failure，Congestive
- Keywords
- Remote physiological monitoring, Qualitative interviews, Perceptions of virtual care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective multi-methods observational study
| Arm | Type | Receives |
|---|---|---|
| Remote physiological monitoring | Experimental | Device: Remote physiological monitoringPatients 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote physiological monitoringParticipants 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. | Device | Remote physiological monitoring |
Primary outcome
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.
1 secondary outcome
Device and app feedback
Time frame: 3-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Background: PubMed 33931237Lorch 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.
- Background: PubMed 33946011Choi 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.
- Background: PubMed 33340672Padwal 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.
- Background: PubMed 30570200Padwal 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.
- Background: PubMed 23337893Hehir 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.
- Background: PubMed 23663957Siehr 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.
- Background: PubMed 27554255Castellanos 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.
- Background: PubMed 22914224Park 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.
- Background: PubMed 33532544Bertagnin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Conway, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote physiological monitoring in people with Pediatric ALL and Congenital Heart Disease, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of technology (time frame: 3-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05034354, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.