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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of patients who stated that the intervention was acceptable as measured by patient and provider interviews.
Proportion of patients willing to consent as measured by enrollment log
Proportion of patients willing to participate as measured by enrollment log
+2 more
Secondary outcome measures
Decision Quality measured by use of the decision conflict scale
Decision to initiate systemic oral anticoagulation measured and documented by physician of record during clinic visit.

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
2,720 Previous Clinical Trials
7,494,234 Total Patients Enrolled
9 Trials studying Atrial Fibrillation
1,212 Patients Enrolled for Atrial Fibrillation
Duke UniversityLead Sponsor
2,381 Previous Clinical Trials
3,427,511 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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