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Decision Support Interventions for Atrial Fibrillation (RED-AF Trial)

N/A
Waitlist Available
Led By Elissa Ozanne, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults (18 and older) diagnosed with Atrial Fibrillation
Be older than 18 years old
Must not have
Deficits in cognitive abilities or sensory input
Timeline
Screening 3 weeks
Treatment Varies
Follow Up we gather medical information at the time of enrollment; again at 6 months; and again at 12 months after enrollment.
Awards & highlights

Summary

This trial will compare how well two different aids work in helping people with atrial fibrillation make decisions about their care, and whether adopting the aid leads to better health outcomes.

Who is the study for?
This trial is for adults over 18 with Atrial Fibrillation who are aware of their condition and have an increased risk of blood clots. It's open to patients at certain sites where clinicians are involved in managing anticoagulation therapy, without exclusions.Check my eligibility
What is being tested?
The study tests if using a Patient Decision Aid (PDA) and an Encounter Decision Aid (EDA) together helps better shared decision-making and adherence to blood thinner treatments compared to using each tool alone in people with Atrial Fibrillation.See study design
What are the potential side effects?
Since the interventions involve decision aids rather than medications, there aren't direct side effects like those from drugs. However, participants may experience stress or confusion when making treatment decisions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older with Atrial Fibrillation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have trouble thinking, remembering, or have issues with my senses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~we gather medical information at the time of enrollment; again at 6 months; and again at 12 months after enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and we gather medical information at the time of enrollment; again at 6 months; and again at 12 months after enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decisional Conflict Scale
Patient Knowledge
Shared Decision Making
Secondary outcome measures
9-item Shared Decision Making Questionnaire (SDMQ9)
Adapted Illness Intrusiveness Ratings
Anticoagulation Adherence 1 - Visual Analogue Scale
+20 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Patient Decision AidExperimental Treatment1 Intervention
Participants in this arm will use the Patient Decision Aid (PDA), an online education tool about atrial fibrillation designed for patient use, prior to the encounter with their provider.
Group II: Patient & Encounter Decision AidsExperimental Treatment2 Interventions
Participants in this arm will use both the PDA & EDA as described above.
Group III: Encounter Decision AidExperimental Treatment1 Intervention
Participants in this arm will use the Encounter Decision Aid (EDA), an online educational tool about atrial fibrillation designed for patient-provider use, during the encounter with their provider.
Group IV: Standard CareActive Control1 Intervention
Participants in this arm will receive standard care, that is they will not use either the PDA or EDA.

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityOTHER
707 Previous Clinical Trials
6,142,333 Total Patients Enrolled
7 Trials studying Atrial Fibrillation
6,962 Patients Enrolled for Atrial Fibrillation
Mayo ClinicOTHER
3,255 Previous Clinical Trials
3,834,206 Total Patients Enrolled
32 Trials studying Atrial Fibrillation
12,388 Patients Enrolled for Atrial Fibrillation
University of MichiganOTHER
1,817 Previous Clinical Trials
6,386,162 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
6,082 Patients Enrolled for Atrial Fibrillation

Media Library

Patient Decision Aid Clinical Trial Eligibility Overview. Trial Name: NCT04357288 — N/A
~262 spots leftby Jul 2025
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