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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
Gregory Y. H. LipMarco ProiettiJohn AinsworthGheorghe-Andrei DanLars FrostGuendalina GraffignaDeirdre A. LaneDonata LucciGianna FabbriFrancisco MarinMartín O’FlahertyMirko PetrovićTatjana PotparaRiccardo ProiettiAlam SanaullahMariya TokmakovaDavide Liborio VetranoSøren Paaske JohnsenSøren Paaske JohnsenAldo P. MaggioniSøren Paaske JohnsenSøren Paaske JohnsenAldo P. MaggioniC GambleMariya TokmakovaLars FrostMarco ProiettiGheorghe-Andrei DanTatjana PotparaFrancisco Marín OrtuñoElena ArbeloGiuseppe Di PasqualeLaurent FauchierDiana GorogJennifer MeessenGianna FabbriElina TrendafilovaAxel BrandesRoberto CeminStefan BogdanD DjikicDavid VivasAldo P. MaggioniFrancesco OrsoDonata LucciAndrea LorimerMartina CeseriMarco GoriniFrancesca BianchiniEster BaldiniB Bartolomei MecattiLucio GonziniMariya TokmakovaАнгел ДжамбовEmanuela VasilevaKostadin KostadinovПенка АтанасоваLars FrostGitte Berg JensenAnita EgholmPeter Brønnum NielsenSøren Paaske JohnsenSøren Paaske JohnsenMarco ProiettiAldo P. MaggioniFrancesco OrsoDonata LucciAndrea LorimerMartina CeseriMarco GoriniFrancesca BianchiniEster BaldiniB Bartolomei MecattiLucio GonziniGheorghe-Andrei DanAdrian Catalina BuzeaAnca Rodica DanRaluca PopescuTatjana PotparaDejan KojicMiroslav MihajlovicNebojsa MujovicFrancisco Marín OrtuñoCecilia López GarcíaJosé Miguel Rivera CaravacaMaria Asuncion Esteve PastorMiguel Ángel Sánchez PérezVanessa Roldán SchillingAntony GogovKostadin KichukovKrastyu PenchevVladimir IvanovRafiela ChitakIskren GarvanskiV. TraykovElena Kostova-DimitrovaSusanne Hekla Ringholm Hansen
Key result
mHealth integrated care fails to reduce unplanned hospitalizations versus usual care in older multimorbid AF.
- adjusted OR 0.95
- 95% CI 0.61-1.49
- P=0.84
- n=1,260
Figures
Why the trial?
Frail, multimorbid, polymedicated older people are largely excluded from atrial fibrillation trials, yet they are the patients hardest to manage. AFFIRMO asked whether an integrated, holistic care pathway improves outcomes in this underserved population.
Does a mHealth-based integrated care management and comprehensive geriatric assessment reduce all-cause unplanned hospitalisation in older multimorbid patients with atrial fibrillation?
Key Points
- To determine whether an integrated mobile health intervention combining the Atrial Fibrillation Better Care pathway with comprehensive geriatric assessment reduces unplanned hospitalizations in older multimorbid patients with atrial fibrillation.
- Multicentre, open-label, cluster-randomised controlled trial conducted across medical centers in six European countries (ClinicalTrials.gov NCT06775028).
- Enrolled 1260 older patients (mean age 74 years; median CHA2DS2-VASc score 4; 97.3% on anticoagulation) allocated by cluster to an integrated mHealth intervention (iABC system; n=634) or guideline-directed usual care (n=626).
- The primary endpoint of all-cause unplanned hospitalisation occurred in 108 of 634 patients (17.1%) in the intervention arm and 114 of 626 patients (18.2%) in the usual care arm (adjusted OR 0.95, 95% CI 0.61–1.49; p=0.84).
- Mobile health application engagement was limited, with 68.5% of intervention participants (433/632) utilizing the app for only one-third of the total study duration.
Evidence details
What drove the result?
| Outcome | mHealth ABC | Usual care |
|---|---|---|
| Unplanned hospitalisations | ||
| Primary · no reduction vs usual care; event rates not reported in the record |
Limitations & tradeoffs
Background therapy
High baseline guideline adherence left little room for the intervention to add benefit (investigator-reported).
Statistical certainty
Event rates were low, limiting statistical power (investigator-reported).
Design limitations
Use of the mobile app was low, diluting the intervention (investigator-reported).
Representation
Investigators judged comprehensive geriatric assessment to have limited efficacy in this relatively well-preserved population.
Structured PICO
Does a mHealth-based integrated care management and comprehensive geriatric assessment reduce all-cause unplanned hospitalisation in older multimorbid patients with atrial fibrillation?
P
Population
1,260 older patients with atrial fibrillation and multimorbidity across six European countries.
I
Intervention
mHealth structured intervention adapting the Atrial Fibrillation Better Care (ABC) pathway, combining comprehensive geriatric assessment (iABC system)
C
Comparator
Usual care (managed according to clinical guidelines)
O
Outcome
All-cause unplanned hospitalisationhard clinical
Main Result
Odds Ratio: 0.95 (95% CI 0.61–1.49)
Absolute Event Rate: 17.1% vs 18.2%
p-value: p=0.84
A mHealth-based integrated care intervention did not reduce unplanned hospitalizations in older, multimorbid patients with atrial fibrillation who already had high baseline guideline adherence.
Limitations
- Suboptimal intervention uptake, with 68.5% of patients using the app for only one-third of the observation time
- High baseline guideline adherence and low event rates in the study population
- Suboptimal intervention uptake (68.5% of patients used the app for only one-third of the observation time)
Discussion
Key questions
No takes yet. Share an insight, caveat, or question.
Where experts stand
Experts view AFFIRMO as a well-intentioned but neutral trial, with most attributing the null result to high baseline guideline adherence and low patient engagement with the mobile app rather than a failure of integrated AF care as a concept.
The reaction to AFFIRMO is largely explanatory rather than divided. Clinicians accept the neutral finding and point to already-good usual care and poor app uptake as the main reasons the intervention could not separate from control. The live question is whether digital integrated care pathways can still prove their value in settings where baseline adherence is lower or app engagement can be improved.
1 take classified by contention axis so far — the map appears as more land.
Still unclear
It remains open whether the ABC pathway delivered through mHealth would work in populations with lower baseline guideline adherence or greater digital engagement. Experts have not addressed whether the comprehensive geriatric assessment component itself added value or whether the intervention might reduce endpoints other than unplanned hospitalisation.
Key expert perspectives
“Our aim is to implement and test the effectiveness of an integrated patient-centred holistic care pathway for the management of older patients with AF and multimorbidity, which will facilitate cooperation among different health disciplines and promote a shared decision-making process. This type of personalised approach could potentially lead to a reduction in physical and mental impairment allowing older patients to cope better with multimorbidity.”
Limited app engagement and already high guideline adherence likely explain the neutral result
Askarinejad highlighted that in 1,260 older multimorbid patients with AF, integrated ABC pathway care plus comprehensive geriatric assessment and digital support did not reduce unplanned hospitalisation versus usual care. He identified limited app engagement and high baseline guideline adherence as the key explanations. He also placed AFFIRMO alongside mAFA and MIRACLE-AF as part of a broader trend of digital health and structured care pathways reshaping AF management.
Marco Vitolo · Electrophysiology · Before results Congratulated the AFFIRMO team and called it an important trial addressing integrated, holistic care based on the ABC pathway in older, multimorbid patients with AF. X post
Implication
mHealth integrated care adds no hospitalization benefit in optimized older multimorbid AF patients; reinforces usual care as sufficient.
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.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).
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
Cite This Study
Lip et al. (2026) conducted an RCT in Atrial fibrillation and multimorbidity (n=1,260). mHealth-based iABC system (Atrial Fibrillation Better Care pathway combined with comprehensive geriatric assessment) vs. Usual care was evaluated on All-cause unplanned hospitalisation (adjusted OR 0.95, 95% CI 0.61-1.49, p=0.84). The mHealth-based iABC system did not reduce all-cause unplanned hospitalisations compared with usual care (17.1% vs 18.2%; adjusted OR 0.95; 95% CI 0.61-1.49; p=0.84).