NIH grant: The Unintended Consequences of Consumer Wearables: A Mechanistic Trial of Psychological Mechanisms Driving Healthcare Utilization in Patients with Atrial Fibrillation (1R01HL180412-01A1)

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NIH grant 1R01HL180412-01A1: The Unintended Consequences of Consumer Wearables: A Mechanistic Trial of Psychological Mechanisms Driving Healthcare Utilization in Patients with Atrial Fibrillation
Institute: {'code': 'HL', 'abbreviation': 'NHLBI', 'name': 'National Heart Lung and Blood Institute', 'admin_org_id': '12500068', 'admin_funding_url': ''}. PI: Lindsey  Rosman. Award: $794797.
Start: 2026-08-15T00:00:00.
ABSTRACT
Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting more than 59 million adults globally and
costing the U.S. healthcare system approximately $6 billion annually. Smartwatches with cardiovascular
monitoring features [heart rate, electrocardiogram (HR, ECG)] are increasingly used by AF patients to manage
their health. While these technologies offer real-time feedback that may motivate positive health behaviors,
they may also heighten anxiety and lead to increased healthcare utilization, especially in response to frequent
alerts and notifications. Cardiac anxiety is common among AF patients and is associated with increased use of
AF healthcare services. Our preliminary data show that AF patients using smartwatches report higher cardiac
anxiety and utilize more AF-specific care than non-users, especially after receiving heart rate or rhythm alerts.
These findings suggest that wearable devices may amplify symptom monitoring and worry in some patients,
driving both necessary and potentially unnecessary medical care. However, prior research has been limited by
cross-sectional data that is prone to selection bias, suggesting the need for a well-powered clinical trial to
establish a causal relationship. To overcome these limitations, we are proposing to conduct a prospective,
mechanistic, randomized clinical trial to test whether cardiac anxiety mediates the effect of smartwatches with
cardiac monitoring features on healthcare use among patients with known AF (n=210). In this two-arm trial,
equal numbers of patients diagnosed with paroxysmal or persistent AF will be randomized to receive either a
Smartwatch with heart rate/electrocardiogram (HR/ECG) monitoring capabilities or one without these
capabilities. Cardiac anxiety and related patient-reported outcomes will be assessed at baseline, 3, 6, 9, and
12 months. The frequency of heart rate alerts and irregular rhythm notifications, and use of ECG features will
be obtained from smartwatches. Healthcare utilization data will be obtained from the electronic heath record
(EHR). We will use this rigorously designed mechanistic clinical trial to: (AIM 1) test the effect of Smartwatches
with HR/ECG on cardiac anxiety (our hypothesized mechanism). We will also (AIM 2) evaluate cardiac anxiety
as a mediator of the relationship between smartwatches and AF-specific healthcare utilization over a 12-month
period and quantify inappropriate healthcare use attributable to false-positive alerts. AIM 3 will identify a risk
profile by exploring predictors of heterogeneity in the development of cardiac anxiety among smartwatch users
and explore whether smartwatch alerts is a secondary mediator of anxiety among those in the HR/ECG group.
AIM 4 will explore potential protective mechanisms that may attenuate anxiety-mediated healthcare use.
OVERALL IMPACT: With over 10 million Americans affected by AF and smartwatch use on the rise,
identifying who benefits—or is harmed—from using these devices for AF management is critical. Findings from
this trial will inform future guidelines, enhance shared decision-making, and support personalized interventions
to promote safe and effective use, potentially reducing healthcare costs and improving patient outcomes.

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