Clinical trial NCT04108884: RedStroke - Reducing Europe's Stroke Incidence
Official title: RedStroke - Reducing Europe's Stroke Incidence: Highly Cost-effective Population Screening Programs for Atrial Fibrillation Coupled With High Diagnostic Yield Confirmation Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Smartphone App
CHA2DS2-VASc-Score
Screening
Cardiovascular risk factors
Outpatient setting
Congestive heart failure
Stroke
Diabetes
Vascular disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: European Union
name: Preventicus GmbH
First posted: 2019-09-30
Enrollment: 1019
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Atrial Fibrillation
timeFrame: 6 months
Secondary outcomes:
measure: Costs related to the AF screening
timeFrame: 6 months
measure: Compliance of patients using the app
timeFrame: 6 months
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
state: Mecklenburg-Vorpommern
city: Pasewalk
country: Germany
facility: Ambulantes Herz-Kreislauf-Zentrum
city: Athens
country: Greece
facility: Asklepeion Hospital
state: Attica
city: Budapest
country: Hungary
facility: Semmelweis University - Heart and Vascular Center
city: Maastricht
country: Netherlands
facility: University Maastricht Polikliniek Hart+Vaat Centrum
state: Limburg
city: Krakow
country: Poland
facility: Jagiellonian University Medical College
state: Lesser Poland
city: Basel
country: Switzerland
facility: Universitiy Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jens Eckstein, MD, PhD
role: STUDY_DIRECTOR
References: