Screening for Atrial Fibrillation With Self Pulse Monitoring

April 4, 2023 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

526

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina, Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Pulse Monitoring Intervention Group
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
Participants will manually monitor pulse for irregularities.
No Intervention: Control Group Standard of Care
The control group will continue with usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-year
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.
1-year
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.
1-year
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.
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Bristol-Myers Squibb Foundation

Investigators

  • Principal Investigator: Anil Gehi, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-2254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication.

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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