New Project АFFIRMO (ATRIAL FIBRILLATION INTEGRATED APPROACH IN FRAIL, MULTIMORBID, AND POLYMEDICATED OLDER PEOPLE) is a contribution to the international project and scientific activity of Medical University of Plovdiv in line with the international framework programs of the European Union.
https://affirmo.eu/
https://cordis.europa.eu/project/id/899871
The project is implemented with a grant under Horizon 2020 Program – the European Framework Programme for Research and Innovation, established by Regulation (EU) No 1291/2013 of the European Parliament and of the Council and has a budget of EUR 80 billion for the seven-year period.
Project team:
Prof. Dr. Mariya Tokmakova, MD – National Project Coordinator
Prof. Dr. Penka Atanasova, MD, Doctor of Medical Sciences – Project Manager for Medical University of Plovdiv
Assoc. Prof. Dr. Angel Dzhambov, Doctor of Medical Sciences – Project Monitoring
Project Contract: Grant Agreement ID: 899871
Period of implementation: 1 May 2021 – 30 April 2026
Horizon 2020 sub-programme:
H2020-EU.3.1. – SOCIETAL CHALLENGES – Health, Demographic Change and Well-Being
H2020-EU.3.1.4. – Active Ageing and Self-Management of Health
Topic: SC1-BHC-24-2020 – Healthcare Interventions for the Management of the Elderly Multimorbid Patients
Funding scheme: Scientific research and innovation (RIA – Research and Innovation Action)
Total project value: EUR 819,487.25
Funding for Medical University of Plovdiv: EUR 146,250.00
The project is implemented in an international consortium of 19 partners from 9 countries (Denmark, Great Britain, Belgium, Sweden, Italy, Romania, Serbia, Spain, and Bulgaria). The coordinator of the project is Aalborg University, Denmark (https://www.en.aau.dk/)
Objectives and tasks
The objective of AFFIRMO is to validate the effectiveness of a patient-centred, stratified care pathway for older patients with multimorbidity (including atrial fibrillation as one of the conditions), with the aim of facilitating a multidisciplinary, shared decision-making process.
The project envisages a controlled trial testing the structured application of appropriate management of elderly patients with polymorbidity in the clinical practice (adapting the ABC approach and integrating CGA tools) versus the usual care.
The study will provide robust evidence for an active holistic integrated approach to the management of common, polymorbid and “high risk” clinical conditions.
Scope
Approximately 50 centers (i.e. clusters) from six European countries (Bulgaria, Denmark, Italy, Romania, Serbia, and Spain) that will include approximately 1,250 patients (25 patients per cluster). The study site will be the centers’ outpatient departments (Cardiology or Internal Medicine/Geriatrics).
Instrumentation
AFFIRMO uses a novel platform (iABC) for a cluster randomized trial design, by randomizing centers to iABC versus the usual care.
In each participating country (Bulgaria, Denmark, Italy, Romania, Serbia, and Spain), centers will be selected under the leadership of National Coordinators on the basis of demonstrated interest in the treatment of patients with polymorbidity and possessed capacity according to criteria established in the project. Participating clusters, from 8 to 10 in each country, will be randomized in a 1:1 ratio – ones receiving intervention to improve the quality of treatment (iABC, experimental group) and ones receiving “usual care” (control group). The randomization will occur in each country after all clusters selected in the country have received approval from the Institutional Review Board (IRB). The schedule for the random assignment of patterns of care (iABC or usual care) to sites will be computer generated at a Central Coordinating Center. Clusters in each country will be stratified into 2 groups: centers with or without an interventional electrophysiology laboratory for atrial fibrillation ablation.
The new platform (iABC), developed for the purposes of the AFFIRMO project, includes a complex of: educational program, healthy or functional diet/physical activity, psychological support (as appropriate), drug treatment, adhering to the guidelines, as well as periodic (re)evaluation.
iABC will provide guidance to obtain more personalized care for patients with arterial fibrillation in the experimental cluster, by applying specific strategies to obtain clinical control for all three pillars of the ABC method.
Throughout the follow-up, the physicians will track and analyze patient data with the purpose to provide the patients with recommendations and/or changes in treatment and lifestyle habits, with the goal of optimal quality of life.
The iABC platform is designed and developed by the University of Manchester and is compatible with web, tablet and mobile devices.
The platform will be available in the following languages: English, Spanish, Danish, Italian, Serbian, Romanian, and Bulgarian.
Management
The Central Coordination Center of the project is the Italian Heart Care Foundation (HCF). The Foundation will interact and manage the regional coordination centers responsible for conducting the study in the different participating countries, as well as the Italian centers.
Results
The study data will be collected for all participants in a dedicated eCRF form, implemented in a computer-based web-based data entry system and in compliance with the Personal Data Protection Directive /GDPR/. Data from the study will be stored in a database located at the Central Coordination Center.
The statistical processing of the data will provide an assessment of the effect of the research strategy, through which it will provide a valuable source of the quality of life, the disease severity, and the independence level of asthenic, polymorbid, and polymedicated elderly patients.
Expected impacts and contributions
Atrial fibrillation (AF) is the most common sustained arrhythmia, and is associated with a significant morbidity and mortality, mainly due to an increased risk of stroke and peripheral thromboembolism, heart failure, dementia, and impaired quality of life. Patients with AF are generally old and with concomitant comorbidities, making their management very complex, characterized by the need of multi-drug (hence, polypharmacy) intervention.
A patient tailored ABC care pathway has been developed to facilitate the evaluation and management of older AF patients with multimorbidity. The ABC pathway focuses on three domains: avoid stroke with Anticoagulation (with optimized VKA or DOAC use); Better symptom management; and optimized management of associated cardiovascular disease and comorbidity.
A controlled study testing a structured implementation of an appropriate management of elderly AF patients with multimorbidity in clinical practice (adapting the ABC pathway) versus usual care would provide reliable evidence of an active holistic integrated management approach of common, multimorbid and “high risk” clinical conditions. AFFIRMO will use a novel platform (iABC) and will apply a cluster randomized trial design, which will randomize centers to iABC versus usual care. Approximately 48 centers from six European countries which will include approximately 1,200 patients with AF with at least 1 coexisting comorbidity, with the objective to improve their clinical outcomes (primary outcome measure of all-cause hospitalizations over a follow-up period of 12 months) and quality of life.
- Health
- New validated patient-centered and stratified care pathways and health care models for management of older patients with multimorbidity and polypharmacy.
- The integrated approach will be implemented and scientifically tested in clinical practice by developing a digital framework (iABC) that will facilitate interactions between patients and different medical professionals, as well as connect primary and secondary care.
- Scientific
- New clinical guidelines and best practices for improved management of older multimorbid patients.
- The integrated pathway proposed in AFFIRMO will be tested against current clinical practice in an interventional study (cluster RCT design).
- For evaluation of the impact on the health system, in the clinical care part, in the context of multimorbidity.
- The evidence provided by the AFFIRMO trial will have scientific validity and will contribute to guidelines and recommendations for clinical practice in various clinical specialties at national and international level.
- Developed or modified qualitative key indicators for effective management of multimorbidity, planning and monitoring the effectiveness of interventions aimed at improving quality of life, mental health, self-management, etc., based on recommendations from the set of core results for the multimorbidity research.
- Training of healthcare professionals on the iABC approach. Facilitated implementation of this integrated care approach in routine clinical settings for patients with multimorbidity including AF and later potentially for other disease clusters.
- Social
- Empowering patients to support self-management of care pathways and improve their quality of life.
- The empowerment process implemented in AFFIRMO will have a major impact on patients, patient associations, caregivers, medical professionals, health organizations, health government agencies, etc., by providing a better understanding of medical conditions and treatment options and by optimizing the communication between healthcare professionals and patients with the purpose to increase their ability to make informed, shared decisions.
- Special training for healthcare professionals on the importance of patient empowerment and improvement of their communication and relationship skills with patients and the persons who take care of them.
- Technological
- A digital platform is available through the use of specially designed technology.
- For older patient with comorbidities.
- The platform will facilitate the implementation of the iABC concept in relation to:
- Compliance with prescriptions;
- Regular symptom reviews with real-time patient data available to relevant caregivers;
- Establishment of an adaptive lifestyle plan with advanced monitoring capability;
- Communication of patients who see all their data with their clinical team by using the platform.
- Cultural
- Concept generalization and knowledge transfer.
- AFFIRMO will outline a new care pathway for optimal management of older patients with multimorbidity (including AF) that is interdisciplinary, cost-effective, and equitable.
- The model proposed in AFFIRMO can also be applied to a wide range of chronic disease clusters, adapting the experience of multimorbidity management, with the support of scientific societies and patient organizations.
- Economic
- Reducing health care costs.
- The care pathway proposed in AFFIRMO has the ambition to improve patient care leading to a reduction in post-hospitalization complications, strokes, and mortality.
- The integrated approach proposed in AFFIRMO also aims to facilitate the transfer of care between physicians and reduce the need for repeated and fragmented medical consultations, which would reduce costs for the health system and for the patients as a result.