Atrial Fibrillation (AF), CKD, COPD, Coronary Arterial Disease (CAD), Diabetes Mellitus, Heart Failure, Hypertension, Peripheral Arterial Disease, Stroke, TIA (Transient Ischemic Attack)
Conditions
Keywords
iABC, Atrial Fibrillation, Cluster Trial
Brief summary
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. The study will be conducted in Bulgaria, Denmark, Italy, Romania, Serbia and Spain .
Detailed description
Controlled study, testing a structured implementation of an appropriate management of elderly AF patients with multimorbidity in clinical practice (adapting the ABC pathway and integrating the means of CGA) versus usual care; it is designed to provide reliable evidence of an active holistic integrated management approach to a common, multimorbid and 'high risk' clinical condition. AFFIRMO use a novel platform (iABC) in a cluster randomized trial design, randomizing centres to iABC versus usual care. Centres will be selected in each participating country (Bulgaria, Denmark, Italy, Romania, Serbia and Spain) under the responsibility of National Coordinators on the basis of a demonstrated interest in managing patients with AF. The 8-10 participating clusters in each country (see study size below) will be randomized in a 1:1 ratio to receive a quality-improvement intervention (iABC, experimental group) or 'usual care' practice (control group). The randomization will occur in each Country once all clusters selected in the Country have obtained IRB approval. The allocation schedule for random assignment of care models (iABC or usual care) to sites will be computer generated at the Central Coordinating Centre. The clusters in each Country will be stratified in 2 groups: Centres with or without interventional electrophysiology laboratory for AF ablation.
Interventions
OTHERiABC platform use
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.
Sponsors
Aalborg University
University of Belgrade
Universidad de Murcia
Carol Davila University of Medicine and Pharmacy
Plovdiv Medical University
University of Liverpool
Heart Care Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Mechanical prosthetic heart valve or moderate/severe mitral stenosis; * Patient unwilling to be enrolled and sign written informed consent; * Patient unable to understand the study and attend the follow-up; * Serious diseases with a life expectancy inferior to 12 months; * Patients included in other interventional studies. Only for sites randomized to the iABC group: \- Patient without a device suitable for iABC use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of iABC on all cause unplanned hospitalization | 12 months | All-cause unplanned hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapy adherence | 12 months | Will be evaluated by persistence medical treatment at 12 month follow-up as reported in the e-CRF |
| Impact of iABC on the composite endpoint of non ischemic stroke, transient ischemic attack and cardiovascular death | 12 months | A 'composite endpoint' of nonfatal ischemic stroke, transient ischemic attack, and cardiovascular death |
| Level of empowerment and engagement of patient assessed with PHE-S questionnaire | 12 months | Level of empowerment and engagement of patient assessed with PHE-S questionnaire |
| Level of adherence to iABC pathway | 12 months | Level of adherence to iABC pathway will be evaluated by: * the number of accesses to the APP. * daily patient's adherence to oral anticoagulant therapy, * weekly blood pressure and weight self-measurements input * weekly AF symptoms related questionnaires completion |
| Impact of iABC on self reported physical activity | 12 months | Impact of iABC on self reported physical activity |
| Impact of iABC on secondary outcome measures | 12 months | all-cause mortality |
Countries
Bulgaria, Denmark, Italy, Romania, Serbia, Spain
Contacts
Primary ContactAldo P Maggioni, MD
Outcome results
None listed