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Trial registered on ANZCTR


Registration number
ACTRN12616001374459
Ethics application status
Approved
Date submitted
26/09/2016
Date registered
4/10/2016
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
SMart watches & mobile smart phone electrograms assessing ARrhythmia TrendS: Smarts Study
Assess utility of smart watches and mobile smart phone electrograms in arrhythmias
Scientific title
Utility of smart watches and mobile smart phone electrograms in arrhythmias: SMARTS Study
Secondary ID [1] 290214 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SMARTS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
arrhythmia 300389 0
atrial fibrillation 300392 0
heart rate 300393 0
Condition category
Condition code
Cardiovascular 300255 300255 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Assess the utility in two commercially available smart watches (Apple watch-Apple Inc., California, United States; Fitbit Blaze-Fitbit Inc., San Francisco, United States) in heart rate assessment among patients with arrhythmias and comparing this to control patients in normal sinus rhythm,
- We would assess the accuracy of smart watches in heart rate calculation among patients with bradyarrhythmias, tachyarrhythmias and assess if commercially available devices offer a novel solution to long term monitoring of heart rate trends in patients
- All patients recruited would have two smart watches on either wrist and a pulse oximeter (with heart rate estimation) in addition to a ward telemetry 5 lead electrocardiogram fitted on simultaneously.
- The devices will be assessed for a period of 30 minutes to assess the heart rate trends between devices and if the smart watches and oximeter compare in accuracy to the gold standard which is the 5 lead electrocardiogram.
- Inpatients will be monitored while sitting up in bed on the ward for 1x30 minute session and outpatients undergoing stress testing will be on a treadmill (for the duration of the stress test)
- This intervention will be carried out by a cardiology specialist registrar with a minimum 5 year experience
- All the patients will be recruited either in an inpatient ward setting (majority), outpatient stress testing within cardiology department.
- In addition we will also utilize a mobile smart phone based electrocardiogram in patients (AliveCor Inc. USA) in patients with arrhythmias to assess the accuracy of this technology. Mobile smart phone based heart rate monitoring is an alternative method of heart rate and rhythm estimation which we are aiming to validate in a variety of arrhythmias.
- This will be utilized in all patients following the 30 minutes of smart watch monitoring for a period of 2 minutes to obtain 3x30 second electrocardiogram traces.
- In addition to the smart watch cohort of patients, we aim to use AliveCor Technology in those patients with atrial fibrillation or flutter undergoing a cardioversion to assess the utility of this technology in rate and accurate rhythm estimation.
- Although using this on a different cohort of patients, we aim to answer the same question, i.e. is wearable technology or mobile smart phone electrocardiograms accurate in arrhythmias.
- We will also validate the use of the single lead ECG (AliveCor) in comparison to a 12 lead ECG among cardiologists, general physicians and general practitioners
- The AliveCor ECG sensors attached to the back of a smart phone are held using both hands by the participant with the smart phone application remotely recording the heart rhythm trace on the screen.
- A 12 lead ECG and a single lead ECGx 3 30 second traces (AliveCor) will be performed prior to and following the cardioversion
Intervention code [1] 295981 0
Treatment: Devices
Comparator / control treatment
- Control group for accuracy of these devices in patients with arrhythmias will be patients in normal sinus rhythm who will undergo the same evaluation as above for 30 minutes.
- These participants will use the standard 5 lead electrocardiogram as the gold standard for comparison.
Control group
Active

Outcomes
Primary outcome [1] 299729 0
- Determine accuracy of commercially available smart watches in heart rate assessment
- Heart rate values will be recorded every 15 seconds for the electrocardiogram, smart watches and the oximeter and a comparison will be performed using two techniques.
- Firstly we would calculate the average heart rate over each minute for all devices and compare all values against the gold standard (12 lead electrocardiogram).
- Secondly, we will look to perform statistical analysis to assess the heart rate using a scatter plot to assess the degree of variability between the wearable devices and the electrocardiogram
Timepoint [1] 299729 0
The heart rate values of all devices within the time intervals pre-specified will all be recorded and tabulated together immediately at the end of the 30 minutes of assessment.
Primary outcome [2] 299730 0
- Assess the utility of mobile smart phone based electrocardiogram in patients with arrhythmias
- This will be done using a 12 lead electrocardiogram as a gold standard and comparing the mobile smart phone based tracings to the above.
- This will be interpreted by two cardiac electrophysiologists each with over 10 years of experience.
- We will also in a blinded fashion get both a general physician and general practitioner to assess the same tracings from the smart phone based device to assess the quality and ability to derive a diagnosis from these tracings
Timepoint [2] 299730 0
Following conclusion of recruiting patients and collating all electrocardiograms- in 3 months approximately, the tracings will be distributed for assessment by the electrophysiologists, physician and general practitioner. The assessments will be made for each of the 3x30 second traces in every participant.
Secondary outcome [1] 327956 0
Assess patient's attitudes to utilization of wearable technologies in assessment of heart rate and rhythm. This will be assessed using a questionnaire using a 5-point Likert scale.
Timepoint [1] 327956 0
Immediately after the 30 minute assessment.

Eligibility
Key inclusion criteria
1. >18 years of age
2. Patients admitted to Box Hill Hospital undergoing ward telemetry
3. Patients admitted to Box Hill Hospital for Electrophysiological studies
4. Outpatients at Box Hill Hospital who are undergoing stress echocardiogram testing
5. Control patients will be selected based on electrocardiogram confirming sinus rhythm on the ward with a heart rate between 60-99 beats/minute on average.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. <18 years of age
2. Patents not consenting for the study
3. Patients with a cardiac pacemaker or defibrillator
4. Patients with tattoos around the wrist area
5. Patients unable to stably rest their fingers on the single lead ECG monitor (eg: patients with tremor, arthritis)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Statistical analysis will be conducted at Eastern Health doing a comparative analysis for the devices in determining the accuracy of the heart rate from wearable devices in comparison to the ward electrocardiogram

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6715 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 14360 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 294578 0
Hospital
Name [1] 294578 0
Eastern Health, Department of Cardiology
Address [1] 294578 0
8 Arnold Street, Box Hill, Victoria 3128
Country [1] 294578 0
Australia
Funding source category [2] 297767 0
Hospital
Name [2] 297767 0
Eastern Health Foundation Research Foundation
Address [2] 297767 0
5 Arnold Street, Box Hill 3128 VIC
Country [2] 297767 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
8 Arnold St, Box Hill, Victoria 3128
Country
Australia
Secondary sponsor category [1] 293446 0
None
Name [1] 293446 0
Address [1] 293446 0
Country [1] 293446 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296014 0
Human Research Ethics Committee- Eastern Health
Ethics committee address [1] 296014 0
Office of Research and Ethics
Box Hill Hospital
8 Arnold Street, Box Hill, Victoria 3128
Ethics committee country [1] 296014 0
Australia
Date submitted for ethics approval [1] 296014 0
14/06/2016
Approval date [1] 296014 0
15/07/2016
Ethics approval number [1] 296014 0
LR55/2016

Summary
Brief summary
Utilization of wearable technology in estimation of heart rate has wide reaching implications. Firstly, validation of heart rate measurement using this technology in healthy individuals at rest and exercise is vital for any future research going forward. Secondly, if smart watches prove to be accurate in monitoring heart rate trends among patients with arrhythmias, it could be a useful tool in guiding and monitoring response to pharmacological therapy.

Smart watches and wearable technologies also have the ability to provide longer term monitoring of heart rate compared to 24 hour ECG holter monitoring also called ambulatory monitoring or telemetry - the current standard of care. It may be a cost effective and non-invasive method for patients to remotely assess their heart rate trends and communicate any abnormalities with their cardiologist or general practitioner. This would ensure timely assessment and an earlier change in management strategy that could lead to reduced presentations to the emergency department and improve overall patient satisfaction. Moreover, the ability for patients to accurately track their biometric indices may empower them to be more engaged in their health leading to improved clinical outcomes and quality of life.

In addition to heart rate analysis, a versatile and validated mobile platform for heart rhythm analysis through the use of a mobile single lead ECG device may lead to more widespread adoption of this technology by the clinician.

Methodology
Patients that consent for the study will be provided with two smart watches that use wrist PPG technology as well as a hospital grade pulse oximeter for heart rate assessment. The two smart watches intended for use in this study are the Apple Watch and the FitBit Blaze given their popularity and global market share. Heart rate readings in all patients will be documented using data from an ECG linked with the ward telemetry unit (in the case of inpatients) or an ECG ambulatory monitor (in the case of outpatients undergoing stress echo or ECG) as per standard ward or stress testing protocol.

Each patient will be monitored for a period of approximately 30 minutes with heart rate data being recorded every fifteen seconds among each different modality. Additional parameters recorded include a blood pressure reading at the start and end of the period of monitoring. Baseline characteristics including cardiovascular risk factors, history of arrhythmias and medication use will be noted.

For patients when using the mobile smart phone electrocardiogram, three heart rate recordings using a single lead mobile ECG device (each lasting approximately 30 seconds) will be taken. These readings will be compared to a 12 lead ECG which will be performed during this period as a comparator. For patients undergoing cardioversion, this will be repeated after the cardioversion procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69214 0
Dr Andrew Teh
Address 69214 0
Cardiologist & Electrophysiologist
8 Arnold Street, Box Hill Hospital
Box Hill Victoria 3128
Country 69214 0
Australia
Phone 69214 0
+61422892015
Fax 69214 0
Email 69214 0
teh_wrx@yahoo.com.au
Contact person for public queries
Name 69215 0
Dr Anoop Koshy
Address 69215 0
Cardiology Registrar
8 Arnold Street, Box Hill Hospital
Box Hill, Victoria 3128
Country 69215 0
Australia
Phone 69215 0
+61432661842
Fax 69215 0
Email 69215 0
ankoshy@gmail.com
Contact person for scientific queries
Name 69216 0
Dr Anoop Koshy
Address 69216 0
Cardiology Registrar
8 Arnold Street, Box Hill Hospital
Box Hill Victoria 3128
Country 69216 0
Australia
Phone 69216 0
+61432661842
Fax 69216 0
Email 69216 0
ankoshy@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary