Smartphone-based screening for atrial fibrillation: a pragmatic randomized clinical trial.
Konstantinos D RizasLuisa FreyerNikolay SapplerLukas von StülpnagelPeter SpielbichlerAresa KrasniqiMichael SchreinlechnerFelix N WennerFabian TheurlAmira BehrozElodie EiffenerMathias P KlemmAnnika SchneidewindMartin ZensTheresa DolejsiUlrich Robert MansmannSteffen MassbergAxel BauerPublished in: Nature medicine (2022)
Digital smart devices have the capability of detecting atrial fibrillation (AF), but the efficacy of this type of digital screening has not been directly compared to usual care for detection of treatment-relevant AF. In the eBRAVE-AF trial ( NCT04250220 ), we randomly assigned 5,551 policyholders of a German health insurance company who were free of AF at baseline (age 65 years (median; interquartile range (11) years, 31% females)) to digital screening (n = 2,860) or usual care (n = 2,691). In this siteless trial, for digital screening, participants used a certified app on their own smartphones to screen for irregularities in their pulse waves. Abnormal findings were evaluated by 14-day external electrocardiogram (ECG) loop recorders. The primary endpoint was newly diagnosed AF within 6 months treated with oral anti-coagulation by an independent physician not involved in the study. After 6 months, participants were invited to cross-over for a second study phase with reverse assignment for secondary analyses. The primary endpoint of the trial was met, as digital screening more than doubled the detection rate of treatment-relevant AF in both phases of the trial, with odds ratios of 2.12 (95% confidence interval (CI), 1.19-3.76; P = 0.010) and 2.75 (95% CI, 1.42-5.34; P = 0.003) in the first and second phases, respectively. This digital screening technology provides substantial benefits in detecting AF compared to usual care and has the potential for broad applicability due to its wide availability on ordinary smartphones. Future studies are needed to test whether digital screening for AF leads to better treatment outcomes.
Keyphrases
- atrial fibrillation
- study protocol
- health insurance
- oral anticoagulants
- clinical trial
- left atrial
- catheter ablation
- direct oral anticoagulants
- newly diagnosed
- heart failure
- phase iii
- palliative care
- left atrial appendage
- emergency department
- primary care
- pain management
- risk assessment
- heart rate
- acute coronary syndrome
- open label
- label free
- climate change
- chronic pain
- sensitive detection
- placebo controlled