About this trial
This study evaluates the feasibility and fidelity of an opportunistic atrial fibrillation (AF) screening programme conducted in 38 community pharmacies in Seville (Spain), using the Kardias® 6-lead portable ECG device, coordinated with the emergency medical services centre Salud Responde (CES 061) and primary care physicians. Eligible participants are individuals aged 65 years or older without a prior AF diagnosis who attend a participating pharmacy for any routine purpose. The screening consists of a 30-second ECG recording performed by a trained community pharmacist. Positive or indeterminate results are transmitted in real time to Salud Responde for clinical validation and referral to primary care. The study is evaluated using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The primary outcome is protocol fidelity, measured by the Implementation Adherence Grade (IAG). The study is part of the NUMAPLUS project, funded by INTERREG VI-A España-Portugal (POCTEP 2021-2027), co-financed by the European Regional Development Fund (ERDF).
Eligibility criteria
Qualifiers
Age 65 years or older
Attending a participating community pharmacy for any routine healthcare purpose
No prior documented or patient-reported diagnosis of atrial fibrillation
Capacity to provide written informed consent
Disqualifiers
Confirmed prior diagnosis of atrial fibrillation
Implanted pacemaker, implantable cardioverter-defibrillator (ICD) or other intracardiac device
Clinically evident haemodynamic instability requiring direct emergency 061 activation (active chest pain, severe dyspnoea, syncope)
Concurrent participation in another cardiac rhythm monitoring study
Trial design
Treatments tested in this trial
- Integrated pharmacy-based AF screening circuit
Treatment groups
Sponsors and collaborators
Centro de Emergencias Sanitarias 061 Andalucía
Lead sponsor
Andaluz Health Service
Collaborator
University of Seville
Collaborator
Real e Ilustre Colegio Oficial de Farmacéuticos de Sevilla
Collaborator
Andalusian School of Public Health
Collaborator
Andalusian Regional Ministry of Health
Collaborator