INFORM-AF II-Phase 1 pilot randomised controlled trial evaluating the effect of an atrial fibrillation digital...

Area of Science:

• Cardiology
• Digital Health
• Health Education

Background:

• Atrial Fibrillation (AF) is a growing cardiac arrhythmia requiring complex management.
• Effective patient education is crucial for AF self-management and positive health outcomes.
• The impact of technology-based AF education on hospitalization and patient-reported outcomes remains unclear.

Purpose of the Study:

• To assess the efficacy of the novel, co-designed digital AF educational program, INFORM-AF, in reducing re-hospitalization.
• To evaluate the program's impact on cardiovascular hospitalizations, medication adherence, AF knowledge, and quality of life.
• To determine the cost-effectiveness of the INFORM-AF intervention.

Main Methods:

• A prospective, randomized (1:1), open-label, blinded-endpoint, multicenter clinical trial.
• Participants (≥18 years, diagnosed with AF, smartphone owner) were randomized to the INFORM-AF program or a standard booklet.
• The primary outcome was re-hospitalization within 12 months.

Main Results:

• Study results are anticipated in 2025.
• This pilot study will provide data on the effectiveness of a smartphone-based educational intervention.
• The trial will assess key clinical outcomes, including re-hospitalization rates.

Conclusions:

• The study evaluates a novel digital educational program for Atrial Fibrillation (AF) patients.
• Findings will inform the development of a digital educational framework for AF self-management.
• Results are expected to guide practice recommendations for AF patient education in future guidelines.