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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/show/NCT05401656
Registration number
NCT05401656
Ethics application status
Date submitted
25/05/2022
Date registered
2/06/2022
Date last updated
2/06/2022
Titles & IDs
Public title
A Study to Validate the Apple Watch's ECG Application in Children During or After Cancer Therapy
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Scientific 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
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Secondary ID [1]
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77454
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms
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0
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Cardiac Arrhythmia
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0
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Condition category
Condition code
Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - ECG application
Treatment: Devices - 12 lead ECG
Experimental: ECG App arm - Participants will be provided with Apple iWatch on Day 1 to Day 4 whilst admitted in hospital.
Treatment: Devices: 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.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Recording of a 12 lead ECG and Apple Watch ECG
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Assessment method [1]
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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.
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Timepoint [1]
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Day 1 of inpatient stay
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Primary outcome [2]
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Recording of a 12 lead ECG and Apple Watch ECG
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Assessment method [2]
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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.
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Timepoint [2]
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Day 4 of inpatient stay
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Primary outcome [3]
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Calculation of QT interval by two blinded health professionals
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Assessment method [3]
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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).
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Timepoint [3]
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Day 1 of inpatient stay
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Primary outcome [4]
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Calculation of QT interval by two blinded health professionals
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Assessment method [4]
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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).
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Timepoint [4]
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Day 4 of inpatient stay
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Primary outcome [5]
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Mean and Median QTc measurement using Apple iWatch ECG
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Assessment method [5]
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The mean and median QTc will be calculated separately for Day 1 and Day 4
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Timepoint [5]
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Day 1 and Day 4 of inpatient stay
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Primary outcome [6]
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Mean and Median QTc measurement using 12 lead ECG
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Assessment method [6]
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The mean and median QTc will be calculated separately for Day 1 and Day 4
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Timepoint [6]
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Day 1 and Day 4 of inpatient stay
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Secondary outcome [1]
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Abnormal QTc that is greater than 0.48mm on 12 lead ECG and Apple Watch ECG
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Assessment method [1]
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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.
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Timepoint [1]
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Day 1 and day 4 of inpatient stay
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Secondary outcome [2]
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Sensitivity calculations of Apple Watch vs 12 Lead ECG
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Assessment method [2]
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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.
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Timepoint [2]
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Day 1 and day 4 of inpatient stay
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Secondary outcome [3]
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Specificity calculations of Apple Watch vs 12 Lead ECG
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Assessment method [3]
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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.
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Timepoint [3]
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Day 1 and day 4 of inpatient stay
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Secondary outcome [4]
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To calculate the interobserver variability between the two health care professional readings of QTc.
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Assessment method [4]
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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.
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Timepoint [4]
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Day 1 and day 4 of inpatient stay
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Eligibility
Key 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.
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Minimum age
7
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
30/05/2022
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/05/2023
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Royal Children's Hospital - Parkville
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Recruitment postcode(s) [1]
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3076 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/show/NCT05401656
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Assoc Professor R Conyers
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Address
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Murdoch Children's Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lane Collier
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Address
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Country
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Phone
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0383416200
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/show/NCT05401656
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