Structured care approach for older people with atrial fibrillation and other conditions
Tests a structured care program in older people with atrial fibrillation and several health conditions.
Key facts
- Who runs it
- Heart Care Foundation
- Where
- Caserta, Florence, Genova, Grosseto, Gubbio, Milan, Monza, Naples, Piacenza, Roma, Terni, and Udine, ItalySee the 12 sitesAlso in 5 other countries, 38 sites
- Trial code
- Registry title
- Integrated Approach in Frail Older People with Atrial Fibrillation
- Status
- Recruiting
- People taking part
- 1,250 people, planned
- Started
- 11 Apr 2024
- Planned end
- 31 Jan 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- iABC platform use
- Record updated
- 14 January 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for outpatients aged 65 or older with atrial fibrillation and at least one other long-term illness. It tests a structured team approach to care.
- Age
- 65 years or older
- Sex
- All sexes
- Disease stage
- Atrial fibrillation (first diagnosed, paroxysmal, persistent, long-standing persistent or permanent), confirmed by ECG or Holter monitoring, plus at least 1 other long-term illness
Main reasons for not taking part
- Mechanical prosthetic heart valve or moderate/severe mitral stenosis
- Serious disease with life expectancy under 12 months
- Unable to understand the study or attend follow-up
- Taking part in other interventional studies
- Unwilling to sign written informed consent
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Outpatients of both sexes with age ≥65 years
- First diagnosed, paroxysmal, persistent, long-standing persistent or permanent AF, confirmed as per guideline-recommended diagnostic criteria for AF, e.g. with electrocardiogram (ECG) or Holter monitoring
- ≥1 additional long-term comorbidity, thus fulfilling the definition of multimorbidity: hypertension (treated with at least 2 antihypertensive drugs), coronary artery disease (CAD), peripheral artery disease, heart failure, stroke/TIA, diabetes mellitus, COPD, CKD
Who cannot take part
- Mechanical prosthetic heart valve or moderate/severe mitral stenosis
- Serious diseases with a life expectancy inferior to 12 months
- Patient unwilling to be enrolled and sign written informed consent
- Patient unable to understand the study and attend the follow-up
- Patients included in other interventional studies; Only for sites randomized to the iABC group:
- Patient without a device suitable for iABC use
Where in Italy
Also in 5 other countries, 38 sites
- Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica UniversitariaCaserta, ItalyContact: Paolo Calabro', MDTaking people
- Ospedale Santa Maria Nuova-Cardiologia - Firenze 1Florence, ItalyContact: Alessandro Paoletti PeriniTaking people
- Als Genovese Palazzo Della Salute-Cardiologia QuartoGenova, ItalyContact: Maria Luisa Biorci, MDTaking people
- Ospedale Della Misericordia-U.O. Di CardiologiaGrosseto, ItalyContact: Luigi Addonisio, MDTaking people
- Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E CardiologiaGubbio, ItalyContact: Deborah Cosmi, MDTaking people
- Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure SubacuteMilan, ItalyContact: Marco Proietti, MDTaking people
- Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. CardiologiaMonza, ItalyContact: Elena Pazzi, MDTaking people
- Aou Federico Ii-Medicina Metabolico-RiabilitativaNaples, ItalyContact: Alberto Maria Marra, MDTaking people
- Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E UticPiacenza, ItalyContact: Daniela Aschieri, MDTaking people
- Policlinico Umberto Primo-Medicina Interna E Immunologia ClinicaRoma, ItalyContact: Stefania Basili, MDTaking people
- Azienda Ospedaliera Santa Maria-Medicina InternaTerni, ItalyContact: Giacomo Pucci, MDTaking people
- Pou "Santa Maria Della Misericordia"-S.O.C. CardiologiaUdine, ItalyContact: Marzia De Biasio, MDTaking people
About the trial
What the trial wants to find out
The study will verify if a structured multidisciplinary approach (called iABC), aimed to improve the appropriate management of elderly AF patients with multimorbidity (the i-ABC group), would provide a clear evidence of an improvement in clinical conditions and quality of life compared to usual clinical care. The i-ABC group in AFFIRMO will follow the ABC pathway, focused on three domains: avoid stroke with anticoagulation (with optimized VKA or label-adherent DOAC use); better symptom management; and optimized management of associated cardiovascular and non cardiovascular comorbidities.
Read full original descriptionShow less
The study will be conducted in Bulgaria, Denmark, Italy, Romania, Serbia and Spain .
The 2 groups in the trial
- Quality-improvement intervention (iABC)Treatment being tested
The novel platform (iABC) that will be used in AFFIRMO will consist of an educational program, a healthy or functional diet/physical activity, guideline-adherent drug treatments, periodic (re)assessment. iABC will provide guidance to obtain a more personalized care to AF patients in the experimental cluster implementing specific strategies to obtain clinical control for all the three pillars of the ABC pathway. During the entire follow-up the physician will be able to check the data imputed by the patients and, eventually, contact the patient to provide recommendations and to discuss changes to the treatments and lifestyle habits.
Treatment: iABC platform use
- Usual careNo study treatment, for comparison
Patients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People
- Plain-language title
- Structured care approach for older people with atrial fibrillation and other conditionsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Integrated care management and comprehensive geriatric assessment using a mHealth-based approach in older multimorbid patients with atrial fibrillation: the AFFIRMO cluster-randomised trial.The Lancet regional health. Europe, 2026
- Integrated care management for older multimorbid patients with atrial fibrillation: Rationale, design and baseline characteristics for the atrial fibrillation integrated approach in frail, multimorbid and polymedicated older people (AFFIRMO) trial.American heart journal, 2026
- Record updated
- 14 January 2025