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).
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
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
Single group
Integrated pharmacy-based AF screening circuit
Other interventionA coordinated opportunistic screening model integrating community pharmacies, emergency medical services (Salud Responde, CES 061) and primary care physicians. The model comprises: opportunistic patient identification during routine pharmacy visits; 30-second ECG recording using the Kardias 6-lead portable device; real-time data transmission via the Numaplus platform; structured clinical triage by Salud Responde nursing staff; and referral to primary care for definitive diagnosis and treatment. Implementation strategies include a structured EASP-accredited online training programme, ongoing technical support, activity feedback reports and a performance-based financial incentive of 20 euros per complete valid case.
Implementation Adherence Grade (IAG)
Implementation Adherence Grade (IAG) Composite fidelity index expressed as the percentage of mandatory protocol items completed per screening case, calculated as (number of mandatory items completed / 5) × 100. The five mandatory items, each scored dichotomously as completed (1) or not completed (0) and weighted equally, are: (1) written informed consent obtained and documented; (2) minimum demographic data recorded; (3) complete CHA₂DS₂-VA score calculated; (4) successful 30-second ECG tracing obtained within a maximum of three attempts; and (5) documented contact with Salud Responde for all cases classified as suspected or indeterminate atrial fibrillation. The pharmacy-level and study-level IAG is the mean of individual case-level IAG values. Target value: ≥90%. Unit of Measure: Percentage of mandatory protocol items completed (single composite index).
Participation rate (Reach)
Proportion of patients aged 65 years or older who accept screening divided by the monthly denominator of unique patients aged 65 years or older attending each pharmacy.
Pharmacy-level adoption rate
Number of pharmacies completing at least one valid screening divided by the number of invited pharmacies.
Acceptability of Intervention Measure (AIM) score
Mean score of the 4-item AIM scale (range 1-5) measuring pharmacist acceptability of the screening programme.
Feasibility of Intervention Measure (FIM) score
Mean score of the 4-item FIM scale (range 1-5) measuring pharmacist-perceived feasibility of the screening programme.
Click on the lead sponsor to view all of their trials.
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
This trial is not recruiting at the moment. You can still explore other options:
