Integrated Approach in Frail Older People with Atrial Fibrillation
- Conditions
- Atrial Fibrillation (AF)Heart FailurePeripheral Arterial DiseaseCKDStrokeHypertensionCoronary Arterial Disease (CAD)COPDDiabetes MellitusTIA (Transient Ischemic Attack)
- Registration Number
- NCT06775028
- Lead Sponsor
- Heart Care Foundation
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1250
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Impact of iABC on all cause unplanned hospitalization 12 months All-cause unplanned hospitalization
- Secondary Outcome Measures
Name Time Method 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
Impact of iABC on secondary outcome measures 12 months occurrence of renal dysfunction or worsening renal function
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 completionImpact of iABC on self reported physical activity 12 months Impact of iABC on self reported physical activity
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
Therapy adherence 12 months Will be evaluated by persistence medical treatment at 12 month follow-up as reported in the e-CRF
Related Research Topics
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Trial Locations
- Locations (50)
MHAT Haskovo AD-Cardiology
🇧🇬Haskovo, Bulgaria
SHATS Sveti Georgi - Pernik-Cardiology
🇧🇬Pernik, Bulgaria
MBAL Sv. Ivan Rilski-Cardiology
🇧🇬Plovdiv, Bulgaria
UMBAL Sveti Georgi EAD-Clinic of Cardiology
🇧🇬Plovdiv, Bulgaria
UMHAT Pulmed Plovdiv-Cardiology
🇧🇬Plovdiv, Bulgaria
Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology
🇧🇬Sofia, Bulgaria
Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY
🇧🇬Sofia, Bulgaria
National Heart Hospital-ICCU
🇧🇬Sofia, Bulgaria
Herlev Hospital-Department of Cardiology
🇩🇰Herlev, Denmark
North Denmark Regional Hospital-Department of Cardiology
🇩🇰Hjoerring, Denmark
Scroll for more (40 remaining)MHAT Haskovo AD-Cardiology🇧🇬Haskovo, BulgariaANTONY GOGOV, MDContact