Pharmacy-based Opportunistic Atrial Fibrillation Screening Integrated With Emergency Services (NUMAPLUS-FA)
NCT07598903 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380
Last updated 2026-05-22
Summary
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).
Conditions
- Atrial Fibrillation (Prevention of Stroke)
- Arrythmia, Cardiac
- Mass Screening
- Pharmacies
Interventions
- OTHER
-
Integrated pharmacy-based AF screening circuit
A 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.
Sponsors & Collaborators
-
Andaluz Health Service
collaborator OTHER_GOV -
University of Seville
collaborator OTHER -
Real e Ilustre Colegio Oficial de Farmacéuticos de Sevilla
collaborator UNKNOWN -
Andalusian School of Public Health
collaborator OTHER_GOV -
Andalusian Regional Ministry of Health
collaborator OTHER_GOV -
Centro de Emergencias Sanitarias 061 Andalucía
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2026-12-15
- Completion
- 2026-12-31
Countries
- Spain
Study Locations
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