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NCT05818592 · ClinicalTrials.gov registry record · NA
Screening for Atrial Fibrillation With Self Pulse Monitoring
A NA study of Atrial Fibrillation New Onset, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 526
- Enrollment target
- 1
- Study location
NCT05818592: Completed NA study of Atrial Fibrillation New Onset, sponsored by University of North Carolina, Chapel Hill.
NCT05818592 is a NA study of Atrial Fibrillation New Onset that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 526 participants, above the 132-participant average among 3 other Atrial Fibrillation New Onset trials with a reported enrollment target (298% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05818592, a NA study of Atrial Fibrillation New Onset, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 526 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Self-Pulse Monitoring
Study Locations (1)
North Carolina
- University of North Carolina, Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2022-05-31 |
| Phase | NA |
What the finished NCT05818592 record still lists
NCT05818592 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, above the 132-participant average among 3 other Atrial Fibrillation New Onset trials with a reported enrollment target (298% higher).
The record links to 1 condition, with Atrial Fibrillation New Onset appearing as the primary indexed condition, and to 1 intervention - of which Self-Pulse Monitoring is the first listed.
NCT05818592 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05818592 about?
NCT05818592 is a clinical study titled "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 d...
What is the current status of trial NCT05818592?
This trial is currently completed. It is a NA study. The enrollment target is 526 participants. The study started on 2020-09-21. Estimated completion is 2022-05-31.
What conditions does trial NCT05818592 study?
This clinical trial studies the following conditions: Atrial Fibrillation New Onset.
What interventions are being tested in trial NCT05818592?
The interventions under investigation include: Self-Pulse Monitoring (OTHER).
Who is sponsoring clinical trial NCT05818592?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05818592 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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