Study of an Integrated Care Approach Using the iABC Platform for Older Adults with Atrial Fibrillation and Multiple Health Conditions
Led by Heart Care Foundation · Updated on 2025-01-14
1250
Participants Needed
50
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
Integrated Approach in Frail Older People with Atrial Fibrillation
Research Team
A
Aldo P Maggioni, MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Diagnosed with atrial fibrillation (paroxysmal, persistent, long-standing persistent, or permanent) confirmed by ECG or Holter monitoring
Have at least one additional long-term health condition such as hypertension treated with at least two medications, coronary artery disease, peripheral artery disease, heart failure, stroke or transient ischemic attack, diabetes mellitus, COPD, or chronic kidney disease
You will not qualify if you...
Presence of mechanical prosthetic heart valve or moderate to severe mitral stenosis
Unwillingness to sign written informed consent
Unable to understand the study or attend follow-up visits
Serious illness with life expectancy less than 12 months
Currently participating in other interventional studies
For iABC group only: lack of a suitable device to use the iABC platform
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
AI-Assisted Smart Family Doctor for Managing Hypertension, Diabetes, and Dyslipidemia in Adults After Coronary Artery Bypass Graft or Percutaneous Coronary Intervention
Studying Inhaled Nitroglycerin to Improve Breathing in Adults with Severe COPD and Lung Blood Vessel High Pressure
PILI 0ina Project to Improve Diet and Health in Native Hawaiian Adults with Cardiometabolic Conditions Through Community Cooking Demonstrations
Study of the Eat Well Produce Prescription Program for Veterans with Hypertension, Diabetes, or Obesity at Risk of Food Insecurity
Phase 2 Study of 18F-mFBG PET Imaging
for Heart Failure Patients with Ischemic Cardiomyopathy
and Implantable Cardioverter-Defibrillators
Pilot Trial of Post-Discharge Counselling and Phone Follow-Up to Lower Heart Failure Readmissions
at Komfo Anokye Teaching Hospital
3D Imaging Study of Right Heart Function During Mechanical Pump Placement for Heart Failure
Evaluating Cardiac Fibrosis in Heart Failure Using 68Ga-FAPI PETCT Compared to MRI
A Pilot Study in Patients with HFrEF and HFpEF
Study of Vascular Function and Blood Flow in Adults with Aging and Diseases Including COPD, Pulmonary Hypertension, Heart Failure, and Hypertension
A Program Combining Home Blood Pressure Monitoring, Community Support, and Telehealth to Improve Care for Adults with High Blood Pressure, Diabetes, or Kidney Disease
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
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.
Marco Proietti, Gregory Y H Lip, John Ainsworth...