Screening for Atrial Fibrillation With Self Pulse Monitoring
- Conditions
- Atrial Fibrillation New Onset
- Interventions
- Other: Self-Pulse Monitoring
- Registration Number
- NCT05818592
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 526
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self-Pulse Monitoring Intervention Group Self-Pulse Monitoring 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
University of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States