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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Enrollment
1,019
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
14 day moblie patch Holter ECG for AF confirmation
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Ambulantes Herz-Kreislauf-Zentrum
Pasewalk, Germany
Asklepeion Hospital
Athens, Attica, Greece
Semmelweis University - Heart and Vascular Center
Budapest, Hungary
University Maastricht Polikliniek Hart+Vaat Centrum
Maastricht, Limburg, Netherlands
Jagiellonian University Medical College
Krakow, Lesser Poland Voivodeship, Poland
Universitiy Hospital Basel
Basel, Canton of Basel-City, Switzerland
Prevalence of Atrial Fibrillation
Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group
Time frame: 6 months
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.
Time frame: 6 months
Compliance of patients using the app
Number of patients who regularly use the app according to study instructions
Time frame: 6 months
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