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

NCT07598903 | Not Yet Recruiting

• 1 other identifier: 0237_NUMAPLUS_5_E_CASE2
• Study Type: observational
• Target: 380
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

atrial fibrillation; opportunistic screening; community pharmacy; RE-AIM; implementation science; emergency medical services; portable ECG; hybrid implementation study

Outcome Measures

Primary Outcomes (1)

• 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).

  Through study completion, an average of 6 months

Secondary Outcomes (15)

• Participation rate (Reach)

  Monthly, through study completion, an average of 6 months

• Pharmacy-level adoption rate

  At end of recruitment period (month 6)

• Acceptability of Intervention Measure (AIM) score

  At end of recruitment period (month 6)

• Feasibility of Intervention Measure (FIM) score

  At end of recruitment period (month 6)

• Suspected AF detection rate.

  Through study completion, an average of 6 months

Study Arms (1)

Pharmacy-based AF screening cohort

Adults aged 65 years or older attending participating community pharmacies in Seville without prior diagnosis of atrial fibrillation, recruited opportunistically during routine pharmacy visits.

Other: Integrated pharmacy-based AF screening circuit

Interventions

Integrated pharmacy-based AF screening circuit OTHER

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.

Also known as: Numaplus digital platform, Salud Responde CES 061, Kardias 6-lead portable ECG device

Pharmacy-based AF screening cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 65 years or older attending community pharmacies in the province of Seville (Spain) affiliated with the Real e Ilustre Colegio Oficial de Farmaceuticos de Sevilla (RICOFS). Participation was offered to all community pharmacies in the province through an open invitation via RICOFS; 38 pharmacies meeting eligibility criteria volunteered to participate. Pharmacies are distributed across urban, semi-urban and rural health zones of the Seville healthcare management area.

You may qualify if:

• 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

You may not qualify if:

• 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
• Inability to maintain the required position for a 30-second ECG recording

Sponsors & Collaborators

• Centro de Emergencias Sanitarias 061 Andalucía: lead
• 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

Related Publications (5)

• Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, Rycroft-Malone J, Meissner P, Murray E, Patel A, Sheikh A, Taylor SJ; StaRI Group. Standards for Reporting Implementation Studies (StaRI) Statement. BMJ. 2017 Mar 6;356:i6795. doi: 10.1136/bmj.i6795.

  PMID: 28264797 BACKGROUND

• Wahab A, Nadarajah R, Larvin H, Farooq M, Raveendra K, Haris M, Nadeem U, Joseph T, Bhatty A, Wilkinson C, Khunti K, Vedanthan R, Camm AJ, Svennberg E, Lip GY, Freedman B, Wu J, Gale CP. Systematic screening for atrial fibrillation with non-invasive devices: a systematic review and meta-analysis. Lancet Reg Health Eur. 2025 Apr 11;53:101298. doi: 10.1016/j.lanepe.2025.101298. eCollection 2025 Jun.

  PMID: 40276326 BACKGROUND

• Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.

  PMID: 39210723 BACKGROUND

• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

  PMID: 10474547 BACKGROUND

• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

  PMID: 22310560 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

María José ML Luque-Hernández, MD, PhD

CONTACT

+34683511613; mariajose.luque.sspa@juntadeandalucia.es

Jesús Antonio JC Carrillo-Castrillo, MD, PhD

CONTACT

+34 955006300; jesus.carrillo.castrillo@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share