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Behavioral Intervention
Storytelling Intervention for Atrial Fibrillation
N/A
Waitlist Available
Led By Alok Kapoor, MD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Patients with left atrial appendage surgery or device, hospice status, ongoing bleeding, and intracranial bleeding in intralobar territory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months from randomization
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help treat atrial fibrillation & lower stroke risks for African American & Black patients by increasing use of anticoagulants.
Who is the study for?
This trial is for African American and Black patients, 18 or older with a risk of stroke who are recommended but not yet on anticoagulation therapy. It's not for those under 18, non-African Americans, pregnant women, prisoners, or individuals with certain bleeding disorders or recent brain surgery.
What is being tested?
The study tests the impact of storytelling as an intervention to encourage the use of blood thinners in African American and Black patients with atrial fibrillation/flutter to reduce their stroke risk.
What are the potential side effects?
While this trial focuses on storytelling rather than medication side effects directly, generally speaking, anticoagulants can increase the risk of bleeding complications.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had surgery on my heart's left atrial appendage, am not in hospice, and do not have ongoing or recent serious bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months from randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months from randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of participating in the study
Feasibility in terms of recruitment rates
Feasibility in terms of retention rates
+4 moreAwards & 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: Intervention - Patient VideosExperimental Treatment1 Intervention
Videos of African Americans currently taking anticoagulation talking about their experiences with using anticoagulation or blood thinners and successfully navigating setbacks occurring with use including bleeding, falls, strokes, and affording the medications.
Group II: Control - Informational Videos (not patients)Active Control1 Intervention
Informational videos about anticoagulation and blood thinners presented by experts or actors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Storytelling Intervention
2023
N/A
~80
Find a Location
Who is running the clinical trial?
National Institute on Minority Health and Health Disparities (NIMHD)NIH
433 Previous Clinical Trials
1,377,981 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
200 Patients Enrolled for Atrial Fibrillation
University of Massachusetts, WorcesterLead Sponsor
362 Previous Clinical Trials
992,930 Total Patients Enrolled
7 Trials studying Atrial Fibrillation
41,323 Patients Enrolled for Atrial Fibrillation
University of MichiganOTHER
1,854 Previous Clinical Trials
6,433,501 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
7,202 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an African-American adult with a high stroke risk not on blood thinners, but my doctor recommends starting them.You have not seen a regular doctor or heart specialist in the past year.I am under 18, not African American or Black, and don't have a diagnosis of AF or atrial flutter.I have not had surgery on my heart's left atrial appendage, am not in hospice, and do not have ongoing or recent serious bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention - Patient Videos
- Group 2: Control - Informational Videos (not patients)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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