Integrated care management and comprehensive geriatric assessment using a mHealth-based approach in older multimorbid patients with atrial fibrillation: the AFFIRMO cluster-randomised trial

Why clinicians should know about it

• Picked for Gastrointestinal and Colorectal Surgery (top studies of the week, 4 October 2026): No reduction in unplanned hospitalisations despite mHealth intervention
• Picked for Hematology (top studies of the week, 4 October 2026): Cluster RCT, mHealth AF management, no haematology focus
• Picked for Internal Medicine (top studies of the week, 4 October 2026): Cluster RCT, no reduction in unplanned hospitalisations

Abstract

BACKGROUND: The AFFIRMO trial aimed to evaluate the efficacy of a mobile-health (mHealth) structured intervention adapting the Atrial Fibrillation Better Care (ABC) pathway, combining the comprehensive geriatric assessment (CGA), to enhance guideline-directed, holistic AF management and reduce the risk of clinical outcomes in older patients with atrial fibrillation (AF) and multimorbidity. METHODS: In a multicentre, open-label, cluster-randomised study conducted in six European countries, clusters were allocated to usual care or intervention (iABC system) (ClinicalTrials.govNCT06775028, https://clinicaltrials.gov/study/NCT06775028). In usual care clusters, patients were managed according to clinical guidelines. FINDINGS: We enrolled 1260 patients (mean [SD] age 74 [6] years; 44.4% (560/1260) female; median CHA2DS2-VASc 4 [IQR 3-5]), with 634 (50.3%) assigned to intervention and 626 (49.7%) to usual care. Overall, 41.0% (517/1260) had >2 comorbidities, with a high prevalence of anticoagulation (1226, 97.3%) and guideline-recommended therapies. CGA in the intervention arm documented a highly preserved function. The primary endpoint of all-cause unplanned hospitalisation occurred in 108 (17.1%) and 114 (18.2%) patients in the intervention and usual care groups [adjusted OR 0.95, 95% CI 0.61-1.49; p = 0.84]. Use of the AFFIRMO Mobile App was suboptimal, with 68.5% (433/632) of patients using it for only one-third of the observation time. INTERPRETATION: In a setting of high baseline guideline adherence and low event rates, the iABC system did not reduce unplanned hospitalisations compared with usual care. These findings suggest no incremental benefit of mHealth integrated care interventions when applied to optimally managed populations, particularly in the context of suboptimal intervention uptake. FUNDING: European Union's Horizon 2020 Research and Innovation Program (grant agreement 899871).

Abstract as published, via PubMed.