Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001105134
Ethics application status
Approved
Date submitted
29/07/2019
Date registered
12/08/2019
Date last updated
11/02/2021
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Smart Watches for the Diagnosis of Atrial Fibrillation in cardiac patients over 65
Scientific title
Smart Watches for the Diagnosis of Atrial Fibrillation in cardiac patients over 65
Secondary ID [1] 298861 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 313820 0
Condition category
Condition code
Cardiovascular 312226 312226 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Approximately 200 participants attending outpatient cardiology appointments will be recruited. Each participant will have a 12 lead ECG taken and also 30 second recordings from a smart watch. The smart watch rhythm diagnosis will be compared with the 12 lead ECG diagnosis, with a focus on the diagnosis of atrial fibrillation. A brief survey will also be conducted on each participant. Total duration of involvement is 30 minutes. The watch will be worn on either wrist.
Intervention code [1] 315125 0
Diagnosis / Prognosis
Comparator / control treatment
12 lead ECG is the comparator to the smart watch data
Control group
Active

Outcomes
Primary outcome [1] 320868 0
Correct diagnosis of atrial fibrillation by smart watch when review by a cardiologist
Timepoint [1] 320868 0
At the time of acquisition of the ECG recordings
Primary outcome [2] 320905 0
Correct diagnosis of sinus rhythm by smart watch when reviewed by a cardiologist
Timepoint [2] 320905 0
At the time of acquistition of the ECG recordings
Secondary outcome [1] 373142 0
Patient satisfaction with using the smart watch assessed by user questionarie specially designed for this study
Timepoint [1] 373142 0
After ECG recording has been completed

Eligibility
Key inclusion criteria
>65 years of age
Participants at Eastern Health who are attending cardiology clinic
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<65years of age
Participants not consenting for the study
Participants with permanent pacemakers
Participants that are not able to ambulate
Participants inability to rest their fingers on the single lead ECG monitor (eg: patients with tremor, arthritis)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Continuous data will be expressed as a mean with the standard deviation (SD), and categorical data expressed as numbers/percentages. Continuous variables will be compared using Student’s t test. Categorical variables will be compared using Fisher’s exact or chi-square tests as appropriate. All calculated p values are 2 sided, and a p value < 0.05 is considered significant. Statistical analysis will be performed using SPSS package.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Safety concerns
Date of first participant enrolment
Anticipated
12/08/2019
Actual
1/11/2019
Date of last participant enrolment
Anticipated
31/01/2020
Actual
1/03/2020
Date of last data collection
Anticipated
31/01/2020
Actual
1/03/2020
Sample size
Target
200
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14334 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 27337 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 303409 0
Charities/Societies/Foundations
Name [1] 303409 0
Eastern Health Foundation
Country [1] 303409 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Eastern Health Foundation
Address
8 Arnold St
Box Hill
Victoria 3128
Country
Australia
Secondary sponsor category [1] 303458 0
None
Name [1] 303458 0
Address [1] 303458 0
Country [1] 303458 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303939 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 303939 0
5 Arnold St
Box Hill
Victoria 3128
Ethics committee country [1] 303939 0
Australia
Date submitted for ethics approval [1] 303939 0
01/07/2019
Approval date [1] 303939 0
02/07/2019
Ethics approval number [1] 303939 0

Summary
Brief summary
Sales of wearable technology have grown exponentially over the last few years. The latest generation devices promise the ability to diagnose a common abnormal rhythm, atrial fibrillation (AF) which is a leading cause of stroke. However, data on the accuracy of these diagnoses has not been validated in clinical trials.

Our study aims to assess the accuracy of 2 commercially available smart watches for diagnosing AF compared to the gold standard 12 lead ECG. 200 participants will be recruited from the cardiology outpatient clinic. Those over 65 years of age will be included. Exclusion criteria will be: Participants <65 years, unable to provide consent, presence of pacemaker, non-ambulatory participants and those unable to record an ECG on the smart watch (eg. tremor, arthritis). Recordings will be taken from each watch and a 12 lead ECG acquired during the same session. The accuracy of each watch for diagnosing AF and sinus rhythm will be compared to the 12 lead ECG. A brief survey will also be given to each participant. Baseline characteristics including cardiovascular risk factors, history of arrhythmia's and medication use will be noted.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes
Not applicable

Contacts
Principal investigator
Name 95322 0
A/Prof Andrew Teh
Address 95322 0
Cardiology Department, Box Hill Hospital
Level 2, 8 Arnold St
Box Hill, Victoria 3128
Country 95322 0
Australia
Phone 95322 0
+61 3 9895 4833
Fax 95322 0
Email 95322 0
[email protected]
Contact person for public queries
Name 95323 0
Louise Roberts
Address 95323 0
Cardiology Department, Box Hill Hospital
Level 2, 8 Arnold St
Box Hill, Victoria 3128
Country 95323 0
Australia
Phone 95323 0
+61 3 9895 4833
Fax 95323 0
Email 95323 0
[email protected]
Contact person for scientific queries
Name 95324 0
Louise Roberts
Address 95324 0
Cardiology Department, Box Hill Hospital
Level 2, 8 Arnold St
Box Hill, Victoria 3128
Country 95324 0
Australia
Phone 95324 0
+61 3 9895 4833
Fax 95324 0
Email 95324 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD sharing is not within the institutional policies of Eastern Health


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.