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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07598903 on ClinicalTrials.gov