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Trial registered on ANZCTR


Registration number
ACTRN12621001547831
Ethics application status
Approved
Date submitted
20/09/2021
Date registered
12/11/2021
Date last updated
12/11/2021
Date data sharing statement initially provided
12/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A photoplethysmography-based smartphone app (FibriCheck) to detect atrial fibrillation after stroke or transient ischemic attack: a prospective interventional study
Scientific title
A photoplethysmography-based smartphone app (FibriCheck) to detect atrial fibrillation after stroke or transient ischemic attack: a prospective interventional study
Secondary ID [1] 305342 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 323665 0
Stroke 323667 0
Transient Ischemic Attack 323668 0
Condition category
Condition code
Stroke 321210 321210 0 0
Ischaemic
Cardiovascular 321462 321462 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
FibriCheck is a smartphone app that can be used for heart rhythm monitoring and atrial fibrillation (AF) detection. The FibriCheck app will be installed on the smartphone of each consenting participant and detailed instructions will be given on how to use the app. The FibriCheck app will be installed at time of hospital discharge or at a post-discharge clinic visit.

The FibriCheck app uses the smartphone’s built-in camera to measure the heart rate. The participants will be instructed to be in the seated position with the arms resting on a table, holding their smartphone with the right hand, to not speak or move during the measurement to minimize motion artifacts. For the measurement, they should cover the flashlight and the rear camera with their left index finger, and wait for 60 seconds. The 60-second measurement time for the acquisition of the photoplethysmography (PPG) signal is visualized by a countdown clock on the smartphone screen.

After completing the FibriCheck measurement, a context screen will appear where more information can be added to the measurement. Participants will be asked to indicate what they were doing immediately before taking the measurement (sleeping, sitting, standing, walking, exercising, others) and whether they were experiencing any symptoms (palpitations, chest pain, shortness of breath, light-headedness, confusion, fatigue, no symptoms).

Participants will be asked to take at least 3 measurements daily for 3 months.
Adherence to FibriCheck measurements will be assessed using the app analytics by comparing the number of times measurements were taken to the expected number of measurements (3 measurements daily for 3 months)
Intervention code [1] 321752 0
Diagnosis / Prognosis
Intervention code [2] 321950 0
Early detection / Screening
Intervention code [3] 321951 0
Treatment: Devices
Comparator / control treatment
All participants will heart rhythm monitoring by both FibriCheck and a standard of care continuous rhythm monitoring device, Holter monitor or the 'Heartbug' device.
All participants will have the standard of care continuous rhythm monitoring for 1 month.
Adherence to Holter monitoring will be assessed using the app analytics.
Control group
Active

Outcomes
Primary outcome [1] 328993 0
The primary outcome will be any detection of AF in stroke/TIA patients by the FibriCheck app within one month of monitoring.
Timepoint [1] 328993 0
Assessed three times per day for 1 month post-enrolment
Primary outcome [2] 329243 0
The primary outcome will be any detection of AF in stroke/TIA patients by continuous monitoring for one month using Holter monitor/Heartbug
Timepoint [2] 329243 0
Assessed at 1 month post-enrolment
Secondary outcome [1] 401081 0
The ease of use of the app as reported by the participants via a questionnaire.
This will be assessed using a 5-point Likert scale based on questions in the following domains: difficulty in using the app, general satisfaction, feeling of safety/reassurance, physician relationship
Timepoint [1] 401081 0
Assessed at 1 month post-enrolment
Secondary outcome [2] 401082 0
The compliance to the planned PPG measurements (thrice daily for 1 month) assessed by accessing the app analytics (number of measurements recorded versus number of measurements planned or expected)
Timepoint [2] 401082 0
Assessed at 1 month post-enrolment
Secondary outcome [3] 401083 0
The secondary outcome will be any detection of AF in stroke/TIA patients by the FibriCheck app within three months of monitoring.
Timepoint [3] 401083 0
Assessed three times per day for 3 months post-enrolment
Secondary outcome [4] 401864 0
The compliance to the planned PPG measurements (thrice daily for 3months) assessed by accessing the app analytics (number of measurements recorded versus number of measurements planned or expected)
Timepoint [4] 401864 0
Assessed at 3 months post-enrolment

Eligibility
Key inclusion criteria
- Patients with a recent (<30 days) ischemic stroke undergoing non-invasive heart rhythm monitoring (either Holter monitoring or ‘Heartbug’)
- Aged 18 years or older
- Owner of a smartphone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Intracerebral haemorrhage (this does not include haemorrhagic transformation of an ischemic stroke)
- Known history of atrial fibrillation
- Pacemaker
- High probability of a known stroke aetiology such that heart rhythm monitoring is not clinically necessary
- Cognitive impairment or dysphasia precluding effective use of the App
- Inability to install the app in the smartphone or to use it

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All participants with receiving monitoring with both FibriCheck and Holter/HeartBug
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There is no previous study that has specifically used the FibriCheck app in a stroke population. For the estimation of our sample size, we used an estimated prevalence of AF of 15% in patients with acute ischemic stroke as previously reported (Marini et al. Stroke. 2005 Jun;36(6):1115-9.). The minimum sample size for this study was estimated at 196 patients with acute ischemic stroke, based on the formula n=(Z^2×P(1-P))/d^2 where n is the sample size, Z is the level of confidence (1.96), P is expected prevalence (15%), and d is precision (5%).

Statistical analysis will be performed with Stata version 16 (StataCorp, College Station, Texas, United States). Descriptive analysis will be undertaken. Categorical variables will be summarized with frequencies and percentages, and continuous variables with mean and standard deviation or with median and interquartile range depending on the normality of the distribution. Atrial fibrillation detection rates will be determined for the FibriCheck app and for other rhythm monitoring strategies. Agreement for AF detection between FibriCheck and other rhythm monitoring strategies will be evaluated using the Cohen's kappa coefficient. For comparison between groups, the Chi-squared test will be used for categorical variables, and the Mann-Whitney U test for continuous variables. Univariable and multivariable regression analyses will be used to determine factors associated with AF detection by the FibriCheck app. A p-value of = 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
196
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20545 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 20546 0
Calvary Wakefield Hospital - Adelaide
Recruitment postcode(s) [1] 35328 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 309712 0
Commercial sector/Industry
Name [1] 309712 0
Qompium NV
Country [1] 309712 0
Belgium
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 310732 0
None
Name [1] 310732 0
Address [1] 310732 0
Country [1] 310732 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309476 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 309476 0
Level 3, Roma Mitchell Building, 136 North Terrace Adelaide SA 5000
Ethics committee country [1] 309476 0
Australia
Date submitted for ethics approval [1] 309476 0
13/07/2021
Approval date [1] 309476 0
10/08/2021
Ethics approval number [1] 309476 0

Summary
Brief summary
Background:
Ischemic stroke is a leading cause of mortality and disability globally. Atrial fibrillation (AF) is a major cause of stroke. Because AF-related strokes can largely be prevented by oral anticoagulation, an active search for underlying AF is essential in patients with ischemic stroke. In recent years, there has been a surge in the number of health and medical apps for smartphones. Various smartphone apps for heart rhythm monitoring are now available. FibriCheck is one of those smartphone apps that can be used for heart rhythm monitoring and AF detection. It is the first medical smartphone app approved by the United States Food and Drug Administration for heart rhythm disorders. FibriCheck has been shown to have good accuracy in detecting AF. FibriCheck use the phone’s flashlight and built-in camera to register heart rhythm via photoplethysmography technology. To the best of our knowledge, there is no published study on the use of FibriCheck for AF detection after ischemic stroke or transient ischemic attack.

Hypothesis:
The FibriCheck app could be a convenient and effective rhythm monitoring strategy for the detection of AF in patients with recent ischemic stroke or transient ischemic attack.

Aims:
• To assess the ease of use of FibriCheck for rhythm monitoring strategy in patients with acute stroke
• To evaluate the compliance to FibriCheck monitoring schedule in patients with acute stroke
• To determine the AF detection yield of FibriCheck in patients with acute stroke
• To compare the accuracy of FibriCheck for AF detection to other rhythm monitoring strategies

Procedure:
Participants will be recruited in the wards and clinics of the Neurology Department of the Royal Adelaide and Calvary Hospital. 196 patients will be recruited into this observational study. All participants will be asked to take at least 3 measurements daily for 3 months. The FibriCheck app will be provided to the participants free of charge for the duration of the study. All participants will also received a standard of care heart rhythm monitoring using Holter monitor/HeartBug.
Trial website
Trial related presentations / publications
Public notes
Qompium NV funding is in the form of in-kind support, with free access to FibriCheck

Contacts
Principal investigator
Name 114274 0
Prof Prash Sanders
Address 114274 0
Royal Adelaide Hospital., Port Road Adelaide SA 5000
Country 114274 0
Australia
Phone 114274 0
+61 08 83139012
Fax 114274 0
Email 114274 0
[email protected]
Contact person for public queries
Name 114275 0
Jean Jacques Noubiap
Address 114275 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital. Port Road, Adelaide SA 5000
Country 114275 0
Australia
Phone 114275 0
+61 0883139000
Fax 114275 0
Email 114275 0
[email protected]
Contact person for scientific queries
Name 114276 0
Jean Jacques Noubiap
Address 114276 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital. Port Road, Adelaide SA 5000
Country 114276 0
Australia
Phone 114276 0
+61 0883139000
Fax 114276 0
Email 114276 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


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.