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.
Atrial fibrillation is common in older adults, often remains undetected, and is a major risk factor for stroke, heart failure, hospitalization, and death. Digital screening using smartphone-based photoplethysmography provides substantial benefits in detecting atrial fibrillation compared to usual care, but it remains unclear whether such screening improves clinical outcomes. The Austrian Digital Heart Study tests a brand-independent digital atrial fibrillation screening and management pathway embedded in the Austrian public health-care system. Participants randomized to the intervention arm use the 'Pulskontrolle' smartphone application for repeated photoplethysmographic pulse-wave (PPG) recordings. If atrial fibrillation is suspected, confirmatory 7-day ECG patch monitoring is initiated. Participants with positive PPG receive structured digital information, telehealth support, and guideline-oriented management recommendations. The control arm receives usual care without active app-based atrial fibrillation screening. The primary endpoint is hospitalization for stroke of any type within 48 months after randomization. Secondary outcomes include mortality, cardiovascular morbidity, bleeding, atrial fibrillation-related outcomes, health-care utilization, and health-economic endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
100,060
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.
Department of Internal Medicine III, Medical University Innsbruck
Innsbruck, Tyrol, Austria
RECRUITINGHospitalization for stroke of any type (ischemic or hemorrhagic)
Time frame: Up to 48 months
Hospitalization for Ischemic stroke
Time frame: Up to 48 months
Hospitalization for Hemorrhagic stroke
Time frame: Up to 48 months
All-cause mortality
Time frame: Up to 48 months
Cardiovascular mortality
Time frame: Up to 48 months
Hospitalization for heart failure
Time frame: Up to 48 months
The combination of hospitalization for stroke, hospitalization for heart failure and cardiovascular death.
Time frame: Up to 48 months
Hospitalization for bleeding
Time frame: up to 48 months
Fatal bleeding
Time frame: up to 48 months
Cost and incremental cost effectiveness ratio
Time frame: Up to 48 months
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