A Study to Validate the Apple Watch's ECG Application in Children During or After Cancer Therapy

Neoplasms Clinical Trial

Official title:

A Prospective Study in Paediatric, Adolescent and Young Adult Patients Aged 7 to 18 Years of Age Who Are Undergoing or Have Undergone Cancer Therapy to Validate the Use of the Apple Watch's ECG Function in Measuring QT Prolongation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05401656
• Other study ID #: 77454
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: May 29, 2023

Study information

• Verified date: May 2022
• Source: Murdoch Childrens Research Institute
• Contact: Lane Collier
• Phone: 0383416200
• Email: acor[@]mcri.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective study in paediatric, adolescent and young adult patients aged 7 to 18 years to validate the use of the Apple Watch's electrocardiogram (ECG) function in measuring QT prolongation during and or after cancer therapy.

Description:

A prospective study in paediatric, adolescent and young adult patients aged 7 to 18 years to validate the use of the Apple Watch's ECG function in measuring QT prolongation during and or after cancer therapy.

Primary Objective: To evaluate the agreement between QTc measured using 12 lead ECG and Apple Watch using mean absolute error calculations.

Secondary Objectives: 1. To calculate the sensitivity and specificity for measuring prolonged QTc using the Apple Watch.

2. To calculate the interobserver variability between the two health care professional readings of QTc.

Rationale: Leveraging existing wearable technology for monitoring of QTc prolongation has the ability to scale routine screening strategies across large populations, and can facilitate ambulatory care. Utilising the Apple iWatch to monitor QTc prolongation in this study improves patient outcomes by facilitating real-time monitoring of potential irregularities, widespread screening, detection, and quicker initiation of treatment solutions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 29, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• Paediatric or Adolescent diagnosis of cancer AND an inpatient of The Royal Children's Hospital, Melbourne at the time of consent.

• Patient Age = 7 years at time of eligibility screening

• If Age < 18 years, parent or guardian able to provide consent

• Parental or participant ( if > 18 years of age) possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:

• iPhone (5s or later) with iOS version 11.0 or later defined as iPhone model/iOS version used to complete screening eligibility.

• Apple Watch (Series 1 or later) with watchOS version 4.0 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility. Apple Watch will be provided as part of the study.

• Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone.

• Valid phone number associated with iPhone, ascertained from self-report.

• Valid email address, ascertained from self-report.

Exclusion Criteria:

• Less than 7 years of age and unable to wear Apple Watch

• Older than 18 years of age without guardian or parent to provide consent

• Interpreter required for consent purposes

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Neoplasms

Intervention

Device:
• ECG application
The app together with the device (Apple Watch) will record a V1 (Left wrist) or V2 (left ankle) ECG reading. These measurements will be conducted on Day 1 and Day 4.
• 12 lead ECG
The 12 lead ECG will measure corrected QT interval by recording RR and QT intervals on Day 1 and Day 4. This will be performed within the same episode of care as Apple Watch ECG recording. There is no need to perform both at exactly the same time point, but within a 15 minute window.

Locations

Country	Name	City	State
Australia	The Royal Children's Hospital	Parkville	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording of a 12 lead ECG and Apple Watch ECG	12 lead ECG and Apple Watch ECG recordings of QT interval will be taken at the time point of care.The Apple iWatch ECG app will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.	Day 1 of inpatient stay
Primary	Recording of a 12 lead ECG and Apple Watch ECG	12 lead ECG and Apple Watch ECG recordings of QT interval will be taken at the time point of care.The Apple iWatch ECG app will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.	Day 4 of inpatient stay
Primary	Calculation of QT interval by two blinded health professionals	The Apple iWatch ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).	Day 1 of inpatient stay
Primary	Calculation of QT interval by two blinded health professionals	The Apple iWatch ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).	Day 4 of inpatient stay
Primary	Mean and Median QTc measurement using Apple iWatch ECG	The mean and median QTc will be calculated separately for Day 1 and Day 4	Day 1 and Day 4 of inpatient stay
Primary	Mean and Median QTc measurement using 12 lead ECG	The mean and median QTc will be calculated separately for Day 1 and Day 4	Day 1 and Day 4 of inpatient stay
Secondary	Abnormal QTc that is greater than 0.48mm on 12 lead ECG and Apple Watch ECG	From the analysis of QT measurements from Outcome 2, prolonged or abnormal QTc measurement will be noted. An abnormal QTc is greater than 0.48mm. This data will be collected separately for each patient.	Day 1 and day 4 of inpatient stay
Secondary	Sensitivity calculations of Apple Watch vs 12 Lead ECG	Sensitivity is calculated only in the participants who are declared to have QTc prolongation (abnormal QTc) and is calculated as the proportion patients with QTc prolongation on the Apple Watch among those with QTc prolongation on the 12-lead ECG.	Day 1 and day 4 of inpatient stay
Secondary	Specificity calculations of Apple Watch vs 12 Lead ECG	Specificity is calculated only in participants who do not have QTc prolongation and is calculated as the proportion patients who do not have QTc prolongation on the Apple Watch among those who do not have QTc prolongation on the 12-lead ECG.	Day 1 and day 4 of inpatient stay
Secondary	To calculate the interobserver variability between the two health care professional readings of QTc.	The corrected QT interval will be calculated on both Apple Watch ECG and the 12 lead ECG for each patient and measured by a health professional. QT interval will be calculated by the health professional by using the QT and RR interval from the ECGs using Frederichias interval (QTcF = QT divided by cube root of RR). This data will be collected separately for each patient for each patient The standard deviation of the difference in QTc interval between the two observers will be reported.	Day 1 and day 4 of inpatient stay