RedStroke - Reducing Europe's Stroke Incidence

University Hospital, Basel, Switzerland1,019 enrolled

Overview

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

Conditions

Atrial Fibrillation

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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