Pharmacy-based Opportunistic Atrial Fibrillation Screening Integrated With Emergency Services (NUMAPLUS-FA)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentro de Emergencias Sanitarias 061 Andalucía

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

380 Participants
are divided into 1 treatment group

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