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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

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

RED-AF Trial 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.

RED-AF Trial 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.

RED-AF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ we gather medical information at the time of enrollment; again at 6 months; and again at 12 months after enrollment.

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

RED-AF 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityOTHER

703 Previous Clinical Trials

6,142,147 Total Patients Enrolled

7 Trials studying Atrial Fibrillation

6,962 Patients Enrolled for Atrial Fibrillation

Mayo ClinicOTHER

3,205 Previous Clinical Trials

3,765,584 Total Patients Enrolled

32 Trials studying Atrial Fibrillation

12,388 Patients Enrolled for Atrial Fibrillation

University of MichiganOTHER

1,794 Previous Clinical Trials

6,372,716 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are in the current experimental treatment?

"Confirmed. The trial's information on clinicaltrials.gov reveals that it is actively searching for participants. Initially posted in December 2020, with the latest update from May 2022, 1200 patients need to be recruited across 6 medical locations."

Answered by AI

Is enrollment still available for this trial?

"The clinicaltrials.gov page for this experiment indicates that recruitment is currently in progress. This medical trial was first listed on December 16th 2020 and underwent its most recent edit on May 19th 2022."

Answered by AI

In what number of healthcare facilities is this clinical trial currently taking place?

"The Mayo Clinic in Rochester, Minnesota and the University of Alabama at Birmingham in Birmingham, Alabama are two major sites for this trial. Additionally, Northwestern University in Chicago, Illinois is also included amongst 6 other locations offering participation."

Answered by AI

What is the goal of this clinical investigation?

"This study's primary measure, to be determined through post-encounter surveys within a week of the visit, is Decisional Conflict Scale. Secondary outcomes are Preparation for Decision Making assessed by a validated Likert scale from 1 (not at all) to 5 (a great deal), Anticoagulation Adherence 1 measured via a 100 point Visual Analogue Scale from 0% (no medication taken as prescribed) to 100%, and finally Self Reported 7 day pill taking behaviour with questions about missed doses due side effects or costs affecting dosage adherence."

Answered by AI

Recent research and studies

Medical Decision MakingJournal

Validation of a Decision Regret Scale

Brehaut, Jamie C., Annette M. O'Connor, Timothy J. Wood, Thomas F. Hack, Laura Siminoff, Elisa Gordon, and Deb Feldman-Stewart. 2003. “Validation of a Decision Regret Scale”. Medical Decision Making. SAGE Publications. doi:10.1177/0272989x03256005.

Patient Education and CounselingJournal

The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and Psychometric Properties in a Primary Care Sample

Kriston, Levente, Isabelle Scholl, Lars Hölzel, Daniela Simon, Andreas Loh, and Martin Härter. 2010. “The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and Psychometric Properties in a Primary Care Sample”. Patient Education and Counseling. Elsevier BV. doi:10.1016/j.pec.2009.09.034.

Journal of Clinical EpidemiologyJournal

Decision Making During Serious Illness: What Role Do Patients Really Want to Play?

Degner, Lesley F., and Jeffrey A. Sloan. 1992. “Decision Making During Serious Illness: What Role Do Patients Really Want to Play?”. Journal of Clinical Epidemiology. Elsevier BV. doi:10.1016/0895-4356(92)90110-9.

Journal of Thrombosis and HaemostasisJournal