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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05615376




Registration number
NCT05615376
Ethics application status
Date submitted
7/11/2022
Date registered
14/11/2022

Titles & IDs
Public title
Beat to Beat A Study in Paediatric, Adolescent and Young Adult Patients Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG
Scientific title
Beat to Beat 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 Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG
Secondary ID [1] 0 0
88476
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 a wearable device on Day 1 and Day 4 whilst admitted in hospital.


Treatment: Devices: ECG application
The app together with the wearable device 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 the wearable device 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 wearable device ECG
Timepoint [1] 0 0
Day 1 of inpatient stay
Primary outcome [2] 0 0
Recording of a 12 lead ECG and wearable device 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
Secondary outcome [1] 0 0
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
Timepoint [1] 0 0
Day 1 inpatient stay
Secondary outcome [2] 0 0
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
Timepoint [2] 0 0
Day 4 inpatient stay
Secondary outcome [3] 0 0
Sensitivity calculations of wearable device vs 12 Lead ECG
Timepoint [3] 0 0
Day 1 inpatient stay
Secondary outcome [4] 0 0
Sensitivity calculations of wearable device vs 12 Lead ECG
Timepoint [4] 0 0
Day 4 inpatient stay
Secondary outcome [5] 0 0
Specificity calculations of wearable device vs 12 Lead ECG
Timepoint [5] 0 0
Day 1 inpatient stay
Secondary outcome [6] 0 0
Specificity calculations of wearable device vs 12 Lead ECG
Timepoint [6] 0 0
Day 4 inpatient stay
Secondary outcome [7] 0 0
To calculate the interobserver variability between the two health care professional readings of QTc.
Timepoint [7] 0 0
Day 1 inpatient stay
Secondary outcome [8] 0 0
To calculate the interobserver variability between the two health care professional readings of QTc.
Timepoint [8] 0 0
Day 4 inpatient stay

Eligibility
Key inclusion criteria
* Paediatric or adolescent diagnosis of cancer AND an inpatient of The Royal Children's Hospital, Melbourne for at least 5 days 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:

1. iPhone (6s or later) with iOS version 15.0 or later defined as iPhone model/iOS version used to complete screening eligibility.
2. Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone.
3. Valid phone number associated with iPhone, ascertained from self-report.
4. Valid email address, ascertained from self-report.
5. Participants or parents need to be able to press down on the wearable device crown for 30 seconds
Minimum age
7 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to wear the wearable device.
* < 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
Not applicable
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
46
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
3052 - Parkville

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
A/Prof Rachel Conyers
Address 0 0
The Royal Children's Hospital/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
03 9936 6324
Fax 0 0
Email 0 0
acor@mcri.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified data set collected for this analysis of the Beat to Beat trial will be available 12 months after publication of the primary outcome.

The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
The de-identified data set collected for the analysis of the trial will be available for six months after publication of the primary outcome. The study protocol can be obtained from Murdoch Children's Research Institute. Prior to access to any data the following would be required: a data access agreement must be signed by all relevant parties, the investigators of the study must see and approve the analysis plan describing how the data will be analysed. There must be also an agreement around appropriate acknowledgement in any future publications.
Available to whom?
The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.melbournechildrens.com/mctc/


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/study/NCT05615376