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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
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
Secondary ID [1] 0 0
77454
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Cardiac Arrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recording of a 12 lead ECG and Apple Watch ECG
Timepoint [1] 0 0
Day 1 of inpatient stay
Primary outcome [2] 0 0
Recording of a 12 lead ECG and Apple Watch ECG
Timepoint [2] 0 0
Day 4 of inpatient stay
Primary outcome [3] 0 0
Calculation of QT interval by two blinded health professionals
Timepoint [3] 0 0
Day 1 of inpatient stay
Primary outcome [4] 0 0
Calculation of QT interval by two blinded health professionals
Timepoint [4] 0 0
Day 4 of inpatient stay
Primary outcome [5] 0 0
Mean and Median QTc measurement using Apple iWatch ECG
Timepoint [5] 0 0
Day 1 and Day 4 of inpatient stay
Primary outcome [6] 0 0
Mean and Median QTc measurement using 12 lead ECG
Timepoint [6] 0 0
Day 1 and Day 4 of inpatient stay
Secondary outcome [1] 0 0
Abnormal QTc that is greater than 0.48mm on 12 lead ECG and Apple Watch ECG
Timepoint [1] 0 0
Day 1 and day 4 of inpatient stay
Secondary outcome [2] 0 0
Sensitivity calculations of Apple Watch vs 12 Lead ECG
Timepoint [2] 0 0
Day 1 and day 4 of inpatient stay
Secondary outcome [3] 0 0
Specificity calculations of Apple Watch vs 12 Lead ECG
Timepoint [3] 0 0
Day 1 and day 4 of inpatient stay
Secondary outcome [4] 0 0
To calculate the interobserver variability between the two health care professional readings of QTc.
Timepoint [4] 0 0
Day 1 and day 4 of inpatient stay

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.
Minimum age
7 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/05/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/05/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3076 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT05401656
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Assoc Professor R Conyers
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lane Collier
Address 0 0
Country 0 0
Phone 0 0
0383416200
Fax 0 0
Email 0 0
acor@mcri.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/show/NCT05401656