Atrial Fibrillation New Onset
Conditions
Keywords
Atrial Fibrillation
Brief summary
The goal of this clinical trial is to determine the efficacy of self-pulse monitoring in detecting atrial fibrillation (AF) in adult patients at increased risk of stroke. The main questions it aims to answer are: * Is self-screening an effective modality for diagnosis of AF? * Are there clinical differences and outcomes for patients who self-screen? Eligible participants will be randomized to either the intervention group or control group. The control group will continue with usual standard of care. Participants randomized to the intervention group will be asked to: * View an online educational video to teach them the appropriate way to manually check their pulse for irregularities. * Manually check their pulse for 30 seconds twice daily for 14 days. * Patients who screen positive for irregularities will be sent a 14-day wearable cardiac monitor to assess for underlying arrhythmias. Researchers will compare the intervention group to the control group to see if there are clinical differences and outcomes.
Detailed description
Participants will be recruited for this study using MyChart recruiting. Participants meeting inclusion criteria will be invited to participate and can respond interested or decline. Participants who respond interested will complete a brief survey to confirm eligibility prior to consenting. One the participant consents, they will be randomized to the self-pulse check/intervention group or control group.
Interventions
OTHERSelf-Pulse Monitoring
Participants will manually monitor pulse for irregularities.
Sponsors
Bristol-Myers Squibb
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Eligible participants will be randomized to either the intervention group or control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 or greater * No known history of atrial fibrillation or atrial flutter * Access to MyChart * CHA2DS2-VASc sore (described below) \>/= 2 (male) or \>/=3 (female) based on the following criteria: * Two points: Age ≥75, prior stroke * One point: Age ≥65-74, congestive heart failure, hypertension, diabetes, vascular disease
Exclusion criteria
* Prior diagnosis of atrial fibrillation or atrial flutter * Unable to consent * Currently incarcerated * Self-pay/uninsured * Taking anticoagulation for other medical conditions than atrial fibrillation or atrial flutter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants diagnosed with AF in intervention group who screened positive. | 6 weeks | Participants assigned to the intervention group are instructed on how to manually check their pulse to detect irregularities. Those who screen positive for irregularities will be sent a 14-day wearable cardiac monitor to confirm diagnosis of AF. Diagnosis of AF can also be confirmed by electrocardiogram (ECG) at an outpatient clinic visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of participants diagnosed with AF | 1-year | Participant data will be collected from the electronic health record one year after randomization to assess how many participants from each arm are subsequently diagnosed with AF. |
| Amount of time in days to diagnosis of AF from randomization | 1-year | Participant data will be collected from the electronic health record one year after randomization to assess how many participants from each arm are subsequently diagnosed with AF. For participants with a diagnosis of AF, the time in days from randomization to diagnosis will be calculated. |
| Number of participants prescribed anticoagulation | 1-year | Participant data will be collected from the electronic health record one year after randomization to assess how many participants are prescribed anticoagulation medications. |
| Number of participants with stroke, transient ischemic attack (TIA), or systemic embolism | 1-year | Participant data will be collected from the electronic health record one year after randomization to assess how many participants have a diagnosis of stroke, TIA, or systemic embolism. |
Countries
United States
Outcome results
None listed