Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-02 @ 1:14 AM
Study NCT ID:
NCT05818592
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2023-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Atrial Fibrillation With Self Pulse Monitoring
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Screening for Atrial Fibrillation With Self Pulse Monitoring in Patients at Increased Risk of Stroke
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: