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Decision Support Tool for Atrial Fibrillation

N/A
Waitlist Available
Led By Larry Jackson
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of NVAF
Be older than 18 years old
Must not have
Unable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a patient decision support tool will help patients make better decisions about oral anticoagulation for stroke reduction in non-valvular atrial fibrillation, especially Black patients.

Who is the study for?
This trial is for Black and White adults over 18 with non-valvular atrial fibrillation (NVAF) who have a CHA2DS2-VASc score of at least 2, indicating a higher risk of stroke. They must be new patients at primary care or cardiology clinics considering starting oral anticoagulation but cannot participate if they can't speak English or provide informed consent.
What is being tested?
The study tests whether a patient decision support tool can improve the quality of decisions made by patients regarding the use of oral anticoagulants to prevent strokes in NVAF. It aims to see if this tool helps, especially among Black patients, and will assess its feasibility and acceptability.
What are the potential side effects?
Since this trial involves using a decision support tool rather than medication, there are no direct side effects from drugs being tested. However, participants may experience stress or anxiety when making treatment decisions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with non-valvular atrial fibrillation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of completion of questionnaire measures as measured by Research Electronic Data Capture (REDCAP)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Patient Decision Support ToolExperimental Treatment1 Intervention
Patient decision support tool to be used in conjunction with physician counseling to discuss the risk and benefits of systemic oral anticoagulation.
Group II: Usual Healthcare CounselingActive Control1 Intervention
Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,166,474 Total Patients Enrolled
9 Trials studying Atrial Fibrillation
1,198 Patients Enrolled for Atrial Fibrillation
Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,969,409 Total Patients Enrolled
13 Trials studying Atrial Fibrillation
13,281 Patients Enrolled for Atrial Fibrillation
Larry JacksonPrincipal InvestigatorDuke University

Media Library

Patient Decision Support Tool Clinical Trial Eligibility Overview. Trial Name: NCT04956978 — N/A
Atrial Fibrillation Research Study Groups: Patient Decision Support Tool, Usual Healthcare Counseling
Atrial Fibrillation Clinical Trial 2023: Patient Decision Support Tool Highlights & Side Effects. Trial Name: NCT04956978 — N/A
Patient Decision Support Tool 2023 Treatment Timeline for Medical Study. Trial Name: NCT04956978 — N/A
~27 spots leftby Aug 2025
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