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临床试验/NCT07598903
NCT07598903尚未招募不适用

Pharmacy-based Opportunistic Screening for Atrial Fibrillation Using a Portable ECG Device Integrated With Emergency Medical Services: a Prospective Type-1 Hybrid Implementation Study (NUMAPLUS Project)

Centro de Emergencias Sanitarias 061 Andalucía1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
380
试验地点
1

研究概览

简要总结

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).

详细描述

STUDY DESIGN This is a prospective, single-cohort, type-1 effectiveness-implementation hybrid study conducted within the NUMAPLUS project (INTERREG VI-A España-Portugal, POCTEP 2021-2027, co-financed by the European Regional Development Fund). This design was selected because external evidence on the diagnostic accuracy of the Kardias® device is sufficient to justify its deployment, while uncertainty persists regarding the organisational conditions, care pathways and economic incentives required for its sustainable integration into the Andalusian community pharmacy network. The primary focus is on implementation outcomes; clinical outcomes related to atrial fibrillation screening are collected as secondary endpoints. The study is reported in accordance with the Standards for Reporting Implementation Studies (StaRI) guideline.

SETTING The study is conducted in 38 community pharmacies in the province of Seville affiliated with the Real e Ilustre Colegio Oficial de Farmacéuticos de Sevilla (RICOFS), selected by voluntary participation following an open invitation. Eligibility criteria for pharmacies required stable internet connectivity for access to the Numaplus application, completion of pre-study training, and absence of concurrent participation in another cardiovascular screening programme. Priority was given to pharmacies with 24-hour or 12-hour opening schedules. Geographic coverage targets at least three urban health zones per province and at least one semi-urban or rural zone per healthcare management area.

The study articulates three coordination levels: (1) the community pharmacy as the point of patient recruitment and screening; (2) Salud Responde (CES 061) as the clinical validation, risk stratification and real-time coordination node; and (3) the primary care physician as the responsible party for definitive diagnosis and initiation of treatment.

TRAINING OF PARTICIPATING PHARMACISTS Prior to the recruitment period, all enrolled pharmacists completed a structured training programme accredited by the Escuela Andaluza de Salud Pública (EASP) and the Agencia de Calidad Sanitaria de Andalucía (ACSA). The programme was delivered entirely online in asynchronous modality between 23 March and 13 April 2026 (10 hours total) through the EASP Moodle platform. It comprised four learning units: (1) epidemiological basis and scientific rationale for opportunistic AF screening; (2) detection protocol, radial pulse palpation technique, and interpretation of Kardias® device outputs; (3) data entry in the Numaplus platform, risk classification and patient communication within the pharmacy-Salud Responde circuit; and (4) ethical and legal framework, informed consent procedures, and data protection requirements. Certification required completion of all practical activities and a minimum score of 7 out of 10 on the final knowledge assessment.

INTERVENTION

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Centro de Emergencias Sanitarias 061 Andalucía
申办方类型
Other
责任方
Sponsor

研究点 (1)

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