RedStroke - Reducing Europe's Stroke Incidence

Study Overview
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Brief Summary
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In the RedStroke study, the effect of a smartphone application in detecting Atrial Fibrillation (AF) will be assessed in a double-blind randomised controlled multicenter trial. Outpatients with an elevated risk for atrial fibrillation will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. All patients will continue their prior therapy with their general practitioner and obtain every medical treatment indicated. This study will not cause any restrictions on the usual treatment of the study patients. The only difference between the two groups will be, that patients in the app group will be informed by their local PI, if the recordings of the app indicate AF (and obtain a 14 day Holter ECG for AF verification), whereas the patients in the usual care group will obtain the read out of the app at the end of the study.

Official Title
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RedStroke - Reducing Europe's Stroke Incidence: Highly Cost-effective Population Screening Programs for Atrial Fibrillation Coupled With High Diagnostic Yield Confirmation Services

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: App measurement
* Device: 14 day Holter ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent CHA2DS2-VASc score of 3 and above, if patients are aged under 65 years CHA2DS2-VASc score of 2 and above, if patients are aged 65 years or older Exclusion Criteria: history of Atrial Fibrillation current anticoagulation treatment, cardiac implanted electronic device (ICD or/and PM) app cannot be installed due to technical problems (smartphone type, reduced smartphone storage capacity, other) inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant enrollment of the investigator, his/her family members, employees and other dependent persons
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this study, the effect of a smartphone application in detecting AF will be assessed in a double-blind randomised controlled trial. Patients will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. The only difference between the two groups will be, that patients in the app group will be informed by their local PI, if the recordings of the app indicate AF, whereas the patients in the usual care group will obtain the read out of the app at the end of the study (6 months after inclusion).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App Group<br>In the app group, if an episode of arrhythmia is detected with the app, the local investigator will contact the respective patient to schedule an appointment for a 14 day Holter ECG. | Device: App measurement<br>* App measurement twice a day in the first two weeks after enrollment and twice a week (on different days) from the third week onward and whenever patients feel palpitations<br>Device: 14 day Holter ECG<br>* 14 day moblie patch Holter ECG for AF confirmation<br>|
| Other: Standard Care Group<br>The control group will perform the same measurements as the intervention group, with the only difference that a cumulated Portable Document Format (PDF) report is provided after 6 months instead of the immediate feedback in the app group. | Device: App measurement<br>* App measurement twice a day in the first two weeks after enrollment and twice a week (on different days) from the third week onward and whenever patients feel palpitations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Atrial Fibrillation | Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs related to the AF screening | Health care resource utilization data related to AF diagnosis will be collected for all patients during the study. To evaluate the clinical consequences associated with screening, additional endpoints include the initiation of AF-related therapies including anticoagulants, antiarrhythmic agents or hospitalizations with a primary diagnosis of AF. As a general measure of health care utilization, hospitalization for any cause will also be evaluated. | 6 months | 
| Compliance of patients using the app | Number of patients who regularly use the app according to study instructions | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Smartphone App, CHA2DS2-VASc-Score, Screening, Cardiovascular risk factors, Outpatient setting, Congestive heart failure, Stroke, Diabetes, Vascular disease