Screening for Atrial Fibrillation With Self Pulse Monitoring

University of North Carolina (UNC)

Status: Completed

Conditions: Atrial Fibrillation New Onset

Treatments: Other: Self-Pulse Monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05818592

19-2254

Details and patient eligibility

About

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.

Full 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.

Enrollment: 526 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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526 participants in 2 patient groups

Self-Pulse Monitoring Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Self-Pulse Monitoring

Control Group Standard of Care

No Intervention group

Description:

The control group will continue with usual care.