Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000369527
Ethics application status
Approved
Date submitted
1/03/2024
Date registered
28/03/2024
Date last updated
28/03/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Utility of smartwatches for investigation of the patient with palpitations
Scientific title
Utility of smartwatches for investigation of the patient with palpitations
Secondary ID [1] 311650 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palpitations 333103 0
Arrhythmia 333104 0
Condition category
Condition code
Cardiovascular 329791 329791 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with palpitations will be randomised to 2 groups.
1. Control: Investigation with a 24-hour Holter monitor (current standard of care)
2. Intervention: Monitoring with a smartwatch with ECG capabilities (e.g. Fitbit, Applewatch or Withings Scanwatch). Patients will be able to use their own smartwatch. If they do not own one, one will be supplied to them by the study investigators. The duration of monitoring will be 3-months. They will be instructed to take an ECG during an episode of palpitations, and therefore they do not need to wear it if asymptomatic.

We will not collect any other data from the smartwatches beyond patient transmitted ECGs. These ECGs will be obtained via the smartwatch
Intervention code [1] 328110 0
Treatment: Devices
Comparator / control treatment
The control group will be patients in the 24-hour Holter monitor group. They will receive a single 24-hour Holter monitor during the 3-month period.
This is the current standard of care of investigating patients with palpitations. The Holter will be organised via the outpatient clinic at Box Hill Hospital, where a cardiac technologist will set-up the device for patients. The monitoring period will be 24 hours. The Holter monitoring is continuously recording, so therefore patients do not need to perform anything in particular to be adherent to the monitoring.
Control group
Active

Outcomes
Primary outcome [1] 337558 0
Diagnosis of palpitations
Timepoint [1] 337558 0
Diagnosis within 3-months will be the primary outcome.
For those in the smartwatch group, ECGs will be sent when the wearer notices symptoms. These ECGs will be checked periodically by the research team to label a diagnosis.
For those in the Holter monitor, this will be the day of their Holter monitor if a diagnosis is achieved
Secondary outcome [1] 432320 0
Time to diagnosis
Timepoint [1] 432320 0
Time to symptom and ECG rhythm correlation
Time to symptom rhythm correlation in the smartwatch group will be a successful ECG recording from the time of enrolment in the study.
For those in the Holter arm, it will be time from the Holter to enrolment in the trial.

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years of age
Presentation to an ED or a cardiology outpatient clinic with palpitations as the presenting problem
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years of age
Patients unable to provide their own consent to participate
Patients unable to operate a smartwatch (e.g. vision impairment, deforming arthritis)
Patients in whom a symptom-rhythm correlation has already been identified (e.g. via previous Holter)
Syncope
Cardiac arrest

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is at a central administration site, and not involved with recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence
generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
29/06/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315977 0
Government body
Name [1] 315977 0
Eastern Health
Country [1] 315977 0
Australia
Primary sponsor type
Hospital
Name
Box Hill Hospital
Address
Country
Australia
Secondary sponsor category [1] 318118 0
None
Name [1] 318118 0
Address [1] 318118 0
Country [1] 318118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314798 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 314798 0
https://www.easternhealth.org.au/site/item/34-research-ethics
Ethics committee country [1] 314798 0
Australia
Date submitted for ethics approval [1] 314798 0
13/06/2023
Approval date [1] 314798 0
29/02/2024
Ethics approval number [1] 314798 0
E23-012-99894

Summary
Brief summary
The purpose of the study is to assess the efficacy of smartwatches to investigate patients with palpitations. These are commonly worn by members of the general public, and because they are worn continuously may be able to capture an ECG at the time of palpitations. This may have a benefit over Holter monitors, as these are only worn for a 24-hour period - therefore if the palpitations occur outside the 24-hour monitoring period, patients will not receive a diagnosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132770 0
A/Prof Andrew Teh
Address 132770 0
Box Hill Hospital, 8 Arnold Street, Box Hill, Victoria 3128
Country 132770 0
Australia
Phone 132770 0
+61422892015
Fax 132770 0
Email 132770 0
andrew.teh@easternhealth.org.au
Contact person for public queries
Name 132771 0
Edmond Wong
Address 132771 0
Box Hill Hospital, 8 Arnold Street, Box Hill, Victoria, 3128
Country 132771 0
Australia
Phone 132771 0
+61 1300 342 255
Fax 132771 0
Email 132771 0
edmond.wong@easternhealth.org.au
Contact person for scientific queries
Name 132772 0
Edmond Wong
Address 132772 0
Box Hill Hospital, 8 Arnold Street, Box Hill, Victoria, 3128
Country 132772 0
Australia
Phone 132772 0
+61481456832
Fax 132772 0
Email 132772 0
edmond.wong@easternhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.