Screening for Atrial Fibrillation With Self Pulse Monitoring

Study Overview
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Brief Summary
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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
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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.

Official Title
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Screening for Atrial Fibrillation With Self Pulse Monitoring in Patients at Increased Risk of Stroke

Conditions
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Atrial Fibrillation New Onset

Intervention / Treatment
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* Other: Self-Pulse Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible participants will be randomized to either the intervention group or control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Pulse Monitoring Intervention Group<br>Participants view an educational video instructing them on how to manually check their pulse for irregularities. Participants will be instructed to check their pulse for 30 seconds twice daily for 2 weeks. | Other: Self-Pulse Monitoring<br>* Participants will manually monitor pulse for irregularities.<br>|
| No Intervention: Control Group Standard of Care<br>The control group will continue with usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants diagnosed with AF in intervention group who screened positive. | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of participants diagnosed with AF | 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. | 1-year | 
| Amount of time in days to diagnosis of AF from randomization | 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. | 1-year | 
| Number of participants prescribed anticoagulation | Participant data will be collected from the electronic health record one year after randomization to assess how many participants are prescribed anticoagulation medications. | 1-year | 
| Number of participants with stroke, transient ischemic attack (TIA), or systemic embolism | 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. | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation