Screening for Atrial Fibrillation With Self Pulse Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2022-05-31

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.

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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.

Conditions

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Atrial Fibrillation New Onset

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible participants will be randomized to either the intervention group or control group.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Self-Pulse Monitoring

Intervention Type OTHER

Participants will manually monitor pulse for irregularities.

Control Group Standard of Care

The control group will continue with usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self-Pulse Monitoring

Participants will manually monitor pulse for irregularities.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes