Trials / Completed
CompletedNCT04108884
RedStroke - Reducing Europe's Stroke Incidence
RedStroke - Reducing Europe's Stroke Incidence: Highly Cost-effective Population Screening Programs for Atrial Fibrillation Coupled With High Diagnostic Yield Confirmation Services
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,019 (actual)
- Sponsor
- University Hospital, Basel, Switzerland · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | App measurement | 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 |
| DEVICE | 14 day Holter ECG | 14 day moblie patch Holter ECG for AF confirmation |
Timeline
- Start date
- 2019-10-22
- Primary completion
- 2024-01-18
- Completion
- 2024-01-18
- First posted
- 2019-09-30
- Last updated
- 2024-05-17
Locations
7 sites across 6 countries: Germany, Greece, Hungary, Netherlands, Poland, Switzerland
Source: ClinicalTrials.gov record NCT04108884. Inclusion in this directory is not an endorsement.