Actively Recruiting
Led by Heart Care Foundation · Updated on 2025-01-14
1250
Participants Needed
50
Research Sites
N/A
Total Duration
H
Heart Care Foundation
Lead Sponsor
A
Aalborg University
Collaborating Sponsor
Researchers are evaluating a structured multidisciplinary approach called iABC to improve the management of elderly patients with atrial fibrillation (AF) who have multiple long-term health conditions. This study aims to compare the iABC approach with usual clinical care to see if it leads to better clinical outcomes and quality of life. The iABC strategy focuses on three key areas: preventing stroke with appropriate anticoagulation, improving symptom control, and optimizing treatment of related heart and other health conditions. The trial is conducted across several European countries including Bulgaria, Denmark, Italy, Romania, Serbia, and Spain. The study is designed as a cluster randomized trial where participating centers are assigned either to implement the iABC platform or continue their usual care practices. The iABC platform combines an educational program, a healthy diet and physical activity plan, guideline-based medication management, and regular patient reassessments. Doctors using iABC can monitor patient data and provide personalized advice on treatments and lifestyle throughout the study. Centers in the control group will manage patients according to their local standard care guidelines. Participants will be followed for at least 12 months to assess the impact of iABC on outcomes such as unplanned hospitalizations, stroke and cardiovascular events, physical activity levels, patient engagement, and medication adherence. The study includes regular data collection to monitor these factors and assess adherence to the iABC care pathway. This approach aims to provide clear evidence about whether a holistic, integrated care model can improve health and quality of life in older adults with AF and multiple health issues.
CONDITIONS
Integrated Approach in Frail Older People with Atrial Fibrillation
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either a quality-improvement intervention using the iABC platform, which includes an educational program, a healthy or functional diet/physical activity, guideline-adherent drug treatments, and periodic reassessment, or usual care according to local clinical guidance.
Periodic visits during the 12 months of follow-up
Total: 50 locations
1
MHAT Haskovo AD-Cardiology
Haskovo, Bulgaria
Actively Recruiting
2
SHATS Sveti Georgi - Pernik-Cardiology
Pernik, Bulgaria
Actively Recruiting
3
MBAL Sv. Ivan Rilski-Cardiology
Plovdiv, Bulgaria
Actively Recruiting
4
UMBAL Sveti Georgi EAD-Clinic of Cardiology
Plovdiv, Bulgaria
Actively Recruiting
5
UMHAT Pulmed Plovdiv-Cardiology
Plovdiv, Bulgaria
Actively Recruiting
6
Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology
Sofia, Bulgaria
Actively Recruiting
7
Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY
Sofia, Bulgaria
Actively Recruiting
8
National Heart Hospital-ICCU
Sofia, Bulgaria
Actively Recruiting
9
Herlev Hospital-Department of Cardiology
Herlev, Denmark
Actively Recruiting
10
North Denmark Regional Hospital-Department of Cardiology
Hjørring, Denmark
Actively Recruiting
11
Horsens Regional Hospital-Department of Medicine
Horsens, Denmark
Actively Recruiting
12
Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways
Silkeborg, Denmark
Actively Recruiting
13
Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria
Caserta, CE, Italy, 81100
Actively Recruiting
14
Ospedale Santa Maria Nuova-Cardiologia - Firenze 1
Florence, FI, Italy, 50122
Actively Recruiting
15
Als Genovese Palazzo Della Salute-Cardiologia Quarto
Genova, GE, Italy, 16100
Actively Recruiting
16
Ospedale Della Misericordia-U.O. Di Cardiologia
Grosseto, GR, Italy, 58100
Actively Recruiting
17
Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia
Monza, MB, Italy, 20900
Actively Recruiting
18
Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute
Milan, MI, Italy, 20138
Actively Recruiting
19
Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic
Piacenza, PC, Italy, 29100
Actively Recruiting
20
Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia
Gubbio, PG, Italy, 06024
Actively Recruiting
21
Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica
Roma, RM, Italy, 00161
Actively Recruiting
22
Azienda Ospedaliera Santa Maria-Medicina Interna
Terni, TR, Italy, 05100
Actively Recruiting
23
Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia
Udine, UD, Italy, 33100
Actively Recruiting
24
Aou Federico Ii-Medicina Metabolico-Riabilitativa
Naples, Italy, 80131
Actively Recruiting
25
Spitalul Clinic Colentina-Cardiology
Bucharest, Romania
Actively Recruiting
26
Spitalul Clinic Colentina-Internal Medicine
Bucharest, Romania
Actively Recruiting
27
Spitalul Clinic Coltea-Internal Medicine and Cardiology
Bucharest, Romania
Actively Recruiting
28
Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology
Bucharest, Romania
Actively Recruiting
29
Spitalul Clinic de Urgenta Bucuresti-Cardiology
Bucharest, Romania
Actively Recruiting
30
Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology
Bucharest, Romania
Actively Recruiting
31
Spitalul Universitar de Urgenta Elias-Cardiology
Bucharest, Romania
Actively Recruiting
32
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory
Bucharest, Romania
Actively Recruiting
33
Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department
Belgrade, Serbia
Actively Recruiting
34
KBC Bezanijska Kosa-Cardiology Department
Belgrade, Serbia
Actively Recruiting
35
KBC Zemun-Cardiology Department
Belgrade, Serbia
Actively Recruiting
36
University Clinical Centre of Serbia-Department for cardiac arrhythmias
Belgrade, Serbia
Actively Recruiting
37
University Clinical Centre of Serbia-Department for invasive electrophysiology
Belgrade, Serbia
Actively Recruiting
38
University Clinical Centre of Serbia-Emergency centre
Belgrade, Serbia
Actively Recruiting
39
University Clinical Centre of Kragujevac-Cardiology Department
Kragujevac, Serbia
Actively Recruiting
40
University Clinical Centre of Nis-Cardiology Department
Niš, Serbia
Actively Recruiting
41
Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY
Alicante, Spain
Actively Recruiting
42
Hospital General Universitario Santa Lucía-CARDIOLOGY
Cartagena, Spain
Actively Recruiting
43
Hospital Valle del Guadalhorce-CARDIOLOGY
Cártama, Spain
Actively Recruiting
44
Hospital General Universitario de Elche-CARDIOLOGY
Elche, Spain
Actively Recruiting
45
Hospital Universitario Virgen de la Victoria-CARDIOLOGY
Málaga, Spain
Actively Recruiting
46
Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA
Murcia, Spain
Actively Recruiting
47
Hospital General Universitario Reina Sofía-CARDIOLOGY
Murcia, Spain
Actively Recruiting
48
Hospital Universitario San Juan de Alicante-CARDIOLOGY
Sant Joan d'Alacant, Spain
Actively Recruiting
49
Hospital Universitario de Tarragona Joan XXIII-Cardiology
Tarragona, Spain
Actively Recruiting
50
Pius Hospital de Valls-Cardiology
Valls, Spain
Actively Recruiting
A
Aldo P Maggioni, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Marco Proietti, Gregory Y H Lip, John Ainsworth...
https://pubmed.ncbi.nlm.nih.gov/41580107