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Completed

NCT Number: NCT05818592

Screening for Atrial Fibrillation With Self Pulse Monitoring

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.

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Key information

Conditions

Atrial Fibrillation New Onset Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Pulse Monitoring

Other

Participants will manually monitor pulse for irregularities.

Primary outcomes

  1. Number of participants diagnosed with AF in intervention group who screened positive.

    Time frame: 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 outcomes

  1. Total number of participants diagnosed with AF

    Time frame: 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.

  2. Amount of time in days to diagnosis of AF from randomization

    Time frame: 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.

  3. Number of participants prescribed anticoagulation

    Time frame: 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.

  4. Number of participants with stroke, transient ischemic attack (TIA), or systemic embolism

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2023
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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