RedStroke - Reducing Europe's Stroke Incidence

University Hospital Basel

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: App measurement; Device: 14 day Holter ECG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04108884

2019-00908

Details and patient eligibility

About

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.

Enrollment: 1,019 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,019 participants in 2 patient groups

App Group

Experimental group

Description:

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.

Treatment:

Device: 14 day Holter ECG

Device: App measurement

Standard Care Group

Other group

Description:

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.

Treatment:

Device: App measurement