Digital Screening for Atrial Fibrillation to Prevent Stroke (ADHP)
Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Sebastian J Reinstadler, MD, PhD
- Telefonnummer: +4351250425621
- E-mail: sebastian-johannes.reinstadler@i-med.ac.at
Undersøgelse Kontakt Backup
- Navn: Michael Schreinlechner, MD
- E-mail: Michael.Schreinlechner@i-med.ac.at
Studiesteder
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Tyrol
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Innsbruck, Tyrol, Østrig, 6020
- Rekruttering
- Department of Internal Medicine III, Medical University Innsbruck
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Kontakt:
- Michael Schreinlechner, MD
- Telefonnummer: +4351250425621
- E-mail: michael.schreinlechner@i-med.ac.at
-
Kontakt:
- Sebastian J Reinstadler, MD, PhD
- E-mail: Sebastian-Johannes.Reinstadler@i-med.ac.at
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria
- Age ≥ 65 years
- Policyholder in Austria (active unique social insurance number)
- Written electronic informed consent Exclusion Criteria
a) Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Digital atrial fibrillation screening and management
Participants assigned to the experimental arm are offered access to the 'Pulskontrolle' app.
The app supports smartphone-camera photoplethysmography recordings for atrial fibrillation screening, digital education, and atrial fibrillation management support.
Participants with suspected atrial fibrillation undergo confirmatory 7-day ECG patch monitoring.
Confirmed atrial fibrillation triggers structured digital and telehealth-supported guidance according to guideline-oriented care pathways.
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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.
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Ingen indgriben: Usual care
Participants assigned to the control arm receive usual care.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Hospitalization for stroke of any type (ischemic or hemorrhagic)
Tidsramme: Up to 48 months
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Up to 48 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Hospitalization for Ischemic stroke
Tidsramme: Up to 48 months
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Up to 48 months
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Hospitalization for Hemorrhagic stroke
Tidsramme: Up to 48 months
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Up to 48 months
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All-cause mortality
Tidsramme: Up to 48 months
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Up to 48 months
|
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Cardiovascular mortality
Tidsramme: Up to 48 months
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Up to 48 months
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Hospitalization for heart failure
Tidsramme: Up to 48 months
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Up to 48 months
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The combination of hospitalization for stroke, hospitalization for heart failure and cardiovascular death.
Tidsramme: Up to 48 months
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Up to 48 months
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Hospitalization for bleeding
Tidsramme: up to 48 months
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up to 48 months
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Fatal bleeding
Tidsramme: up to 48 months
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up to 48 months
|
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Cost and incremental cost effectiveness ratio
Tidsramme: Up to 48 months
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Up to 48 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Axel Bauer, Medical University Innsbruck
- Ledende efterforsker: Sebastian J Reinstadler, MD, PhD, Medical University Innsbruck
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1408/2025
Plan for individuelle deltagerdata (IPD)
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