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

Status: Not yet enrolling

Conditions: Neoplasms; Cardiac Arrhythmia

Study type: Interventional

Funder types: Other

Identifiers

NCT05401656

77454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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