After months of work, the AFFIRMO project has reached an important milestone by providing crucial data to assess the impact of the new digital care model.

Study Design and Objectives

A crucial component of the project is the interventional clinical study, which is being designed and conducted through Work Packages (WP) 6 and 7, led by the ANMCO Research Center. While WP6 focuses on designing the clinical trial and ensure that it complies with ethical and regulatory requirements across different European countries involved (Italy, Denmark, Bulgaria, Romania, Serbia and Spain), WP7 oversees the implementation of the randomized controlled trial (RCT).

This trial aims to compare two groups of multimorbid patients with AF: patients receiving a structured digital care pathway (iABC group) and patients receiving a standard care by doctors (Usual Care group). This comparison seeks to test wether the iABC digital care pathway improves patient outcomes compared to standard treatment. A total of 1200 patients across 48 hospitals were expected to participate, with an average of 25 patients per hospital.

Recruitment Progress and Key Findings

As of January 31, 2025, the recruitment phase of the study has been successfully completed: 1260 patients have been enrolled (626 receiving UC and 634 receiving iABC intervention).

Patients were equally distributed between the two groups, providing a solid basis for comparative analysis. Recruitment took place at 50 clinical sites, with an average of 25 patients enrolled per centre, which was in line with the original target. 49 of the 50 participating clusters met the target.

Patients were recruited in the six participating countries with the following distribution: 

These figures reflect the active participation of the different national centres, with effective coordination between the sites involved.

The study showed a progressive increase in the number of patients enrolled each month, with peaks in October (254 patients) and November (265 patients). This increase was supported by the progressive activation of clinical sites, which increased from 9 sites in April to 50 sites operational in November 2024. The number of patients recruited increased steadily until the end of the study.

By 31 January 2025, 42% of patients (533 out of 1260) had already had at least one follow-up visit. The current mean follow-up period stands at 41 days, whereas the full study duration is set at one year. A significant challenge remains ensuring the timely completion of electronic case report forms (eCRFs). Some follow-up periods have expired without data being fully recorded.

Some key events reported include 5 deaths and 100 hospitalizations, of which approximately 65 were unplanned (pending validation).

Next Steps

With recruitment now complete, the AFFIRMO study is entering a crucial phase of data collection and analysis to evaluate the impact of the iABC pathway. The main objective remains to determine whether this innovative approach can reduce the rate of hospitalisation compared to usual care. The study will continue to follow patients for one year, with support from the Liverpool Clinical Trials Centre (LCTC, UK) and the ANMCO Research Centre (Italy), ensuring rigorous data collection and in-depth analysis of results.

Stay tuned for more updates!