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

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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.gov NCT06775028, 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 CHA 2 DS 2 -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).

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DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref
Integrated care management and comprehensive geriatric assessment using a mHealth-based approach in older multimorbid patients with atrial fibrillation: the AFFIRMO cluster-randomised trial
Date Crossref
01/08/2026
Éditeur
Elsevier BV
Type
journal-article

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Sujets associés

Atrial Fibrillation Management and OutcomesChronic Disease Management StrategiesHeart Failure Treatment and Management

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