Atrial Fibrillation (Prevention of Stroke), Stroke
Conditions
Keywords
Digital Health, Atrial Fibrillation Screening, Photoplethysmography, Smartphone, ECG Patch, Stroke Prevention, Randomized Controlled Trial, Siteless Trial, Telehealth
Brief 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.
Detailed description
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.
Interventions
DEVICESmartphone-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.
Sponsors
Medical University Innsbruck
AIT Austrian Institute of Technology GmbH
Medical University of Graz
UMIT Tirol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 65 years 2. Policyholder in Austria (active unique social insurance number) 3. Written electronic informed consent
Exclusion criteria
a) Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospitalization for stroke of any type (ischemic or hemorrhagic) | Up to 48 months |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization for Ischemic stroke | Up to 48 months |
| Hospitalization for Hemorrhagic stroke | Up to 48 months |
| All-cause mortality | Up to 48 months |
| Cardiovascular mortality | Up to 48 months |
| Hospitalization for heart failure | Up to 48 months |
| The combination of hospitalization for stroke, hospitalization for heart failure and cardiovascular death. | Up to 48 months |
| Hospitalization for bleeding | up to 48 months |
| Fatal bleeding | up to 48 months |
| Cost and incremental cost effectiveness ratio | Up to 48 months |
Countries
Austria
Contacts
CONTACTSebastian J Reinstadler, MD, PhD
CONTACTMichael Schreinlechner, MD
STUDY_CHAIRAxel Bauer
Medical University Innsbruck
PRINCIPAL_INVESTIGATORSebastian J Reinstadler, MD, PhD
Medical University Innsbruck
Outcome results
None listed