Digital Screening for Atrial Fibrillation to Prevent Stroke (ADHP)

Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Atrial Fibrillation (Prevention of Stroke)
• Intervention / Treatment: Device: Smartphone-based digital atrial fibrillation screening and management pathway

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.

• Study Type: Interventional
• Enrollment (Estimated): 100060
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian J Reinstadler, MD, PhD; Phone Number: +4351250425621; Email: sebastian-johannes.reinstadler@i-med.ac.at
• Study Contact Backup: Name: Michael Schreinlechner, MD; Email: Michael.Schreinlechner@i-med.ac.at

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Department of Internal Medicine III, Medical University Innsbruck
      • Contact: Michael Schreinlechner, MD; Phone Number: +4351250425621; Email: michael.schreinlechner@i-med.ac.at
      • Contact: Sebastian J Reinstadler, MD, PhD; Email: Sebastian-Johannes.Reinstadler@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
No Intervention: Usual care; Participants assigned to the control arm receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospitalization for stroke of any type (ischemic or hemorrhagic)	Up to 48 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Collaborators: Medical University of Graz; AIT Austrian Institute of Technology GmbH; UMIT Tirol
• Investigators: Study Chair: Axel Bauer, Medical University Innsbruck; Principal Investigator: Sebastian J Reinstadler, MD, PhD, Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Estimated): June 29, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Telehealth; Smartphone; Photoplethysmography; Digital Health; ECG Patch; Stroke Prevention; Atrial Fibrillation Screening; Siteless Trial
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation
• Other Study ID Numbers: 1408/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No