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Digital Screening for Atrial Fibrillation to Prevent Stroke
Sponsor: Medical University Innsbruck
Summary
The Austrian Digital Heart Study is a population-based, siteless, randomized, controlled digital trial testing whether a smartphone-based atrial fibrillation screening and management pathway reduces stroke hospitalizations compared with usual care. Adults aged 65 years or older in Austria are randomized to either a digital intervention using the 'Pulskontrolle' app or to usual care. The intervention includes smartphone-camera photoplethysmography for atrial fibrillation screening, confirmatory 7-day ECG patch monitoring in case of suspected atrial fibrillation, and digital education and management support. The primary outcome is hospitalization for stroke of any type within 48 months.
Official title: Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100060
Start Date
2026-06-29
Completion Date
2032-06-01
Last Updated
2026-07-06
Healthy Volunteers
No
Interventions
Smartphone-based digital atrial fibrillation screening and management pathway
Participants randomized to the digital intervention arm receive access to a smartphone-based atrial fibrillation screening and management pathway. The intervention includes photoplethysmography-based pulse wave measurements using a CE-certified smartphone application, followed by confirmatory 7-day ECG patch monitoring in participants with abnormal findings suggestive of atrial fibrillation. Participants with suspected or confirmed atrial fibrillation receive structured digital information, adherence support, and the option of telehealth guidance to facilitate guideline-oriented care. Treatment decisions remain the responsibility of the participant's usual treating physician.
Locations (1)
Department of Internal Medicine III, Medical University Innsbruck
Innsbruck, Tyrol, Austria