跳至主要内容
临床试验/NCT05086991
NCT05086991已完成不适用

AIHEMAF - P "An Innovative Healthcare Model for AF Patients" No-profit Observational Study on the Role of the Community Pharmacist and "The Pharmacy of Services" in the Case Management of Patients Suffering From Atrial Fibrillation and Being Treated With New Generation Oral Anticoagulants

Farmacia La Regina s.r.l.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Model implementation description

研究概览

简要总结

Non-profit observational study on the role of the community pharmacist and "the pharmacy of services" in the case management of patients suffering from atrial fibrillation and being treated with new generation oral anticoagulants

详细描述

Atrial fibrillation is one of the most common cardiac arrhythmias, from which, in Italy, more than a million people are affected and estimates speak of an increase of up to 70% in the coming years. Due to its ability to increase the thrombo-embolic risk, the affected people are subjected to anticoagulant and antiarrhythmic pharmacological interventions in order to protect the patient from highly disabling events such as cerebral stroke or other arterial embolisms.

However, these pharmacological therapies require a dynamic approach over time, as the choice of active ingredients and the relative dosages depend on the patient's overall health status and for this reason it is important that he adheres to the monitoring plan, prepared by a specialist in cardiology, so that therapeutic appropriateness is always guaranteed.ù

In daily clinical practice, the follow-up activities, defined by the guidelines of the European Society of Cardiology (ESC), consist in the evaluation of:

  • General health status
  • Bleeding events and related risk
  • Therapeutic adherence
  • Kidney function
  • Drug interactions
  • Control of heart rhythm and related symptoms
  • Pathology progression

In the recent past, these activities were carried out solely and exclusively by the Specialist Doctor, as the only person authorized to prescribe the new oral anticoagulant drugs. Only recently, with the introduction of the AIFA 97 note, the General Practitioner was given the opportunity to prescribe these drugs to the patient suffering from Non-Valvular Atrial Fibrillation and to carry out the necessary monitoring. Consequently, the visit to the Specialist is reduced to once a year or whenever the General Practitioner deems it appropriate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • age> 18 years,
  • patients suffering from Non-Valvular Atrial Fibrillation and being treated with new generation oral anticoagulants;
  • able to express consent to the study;
  • regularly related to the trial site (Farmacia La Regina S.r.l.)
  • AntiCovid19 vaccination performed.

排除标准

  • 未提供

结局指标

主要结局

Model implementation description

时间窗: 12 months

The primary outcome is mainly descriptive. In fact, the primary objective of the study is to describe the implementation and outcomes of an innovative Smart Clinic model useful for the clinical and pharmacological monitoring of the patient suffering from non-valvular atrial fibrillation treated with new generation oral anticoagulants, in which a community pharmacist, adequately trained, takes on the role of case manager and the patient has the possibility to perform the checks provided in telemedicine and in self-analysis, in the service pharmacy regime, the results of which will be shared in real time with the treating physician and reference specialist of the same. This model is new as there is no coagulation clinic in Italy as in other countries of the world.

次要结局

  • Adherence to therapy(12 months)
  • Prescriptive appropriateness(12 months)
  • Bleeding and / or thrombo-embolic complications;(12 months)
  • Percent of Participants With Adherence to the PDTA(12 months)
  • Pharmacological problems(12 months)
  • Acceptance of reports(12 months)
  • Economic Impact(12 months)

研究者

发起方
Farmacia La Regina s.r.l.
申办方类型
Other
责任方
Sponsor

研究点 (1)

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