Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation

NCT05997914 | Enrolling By Invitation

• 2 other identifiers: STUDY00001248R21MD017646
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

The overall goal of this study is to evaluate the effectiveness of a previously developed storytelling intervention on anticoagulation (AC) initiation/persistence in African American and Black patients with atrial fibrillation/flutter. The investigators hope to gain knowledge that may help treat atrial fibrillation or flutter and lower stroke and adverse cardiovascular event risks for African American and Black patients by increasing the use of blood thinning medications known as anticoagulants.

Conditions

Atrial Fibrillation; Atrial Flutter; Adherence, Medication; Stroke; Bleeding; Narration; Anticoagulants and Bleeding Disorders

Outcome Measures

Primary Outcomes (7)

• Fidelity via viewing time

  Time spent viewing videos

  90 days from randomization

• Fidelity via transportation

  In intervention patients, measure transportation (absorption into a story) using a transportation scale short form where the minimum and maximum values are 1 (Not at all) and 7 (Very much), respectively. Higher scores mean a better outcome (high transportation).

  90 days from randomization

• Feasibility in terms of recruitment rates

  The investigators will calculate the proportion of patients recruited as well as the recruitment rate. The recruitment proportion will be the number of patients randomized over the total of patients approached. The recruitment rate will be the total time (in days) required to recruit the randomized sample.

  90 days from randomization

• Feasibility in terms of retention rates

  The investigators will calculate the per-group retention proportion as the number of individuals from each group remaining in the study after its completion over the total randomized to that group.

  90 days from randomization

• Acceptability of participating in the study

  Participants will be asked to use an acceptability scale (which the investigators will develop later during the study) to rate their agreement with statements about the acceptability of using the video website, completing the transportation scale short survey (intervention participants only), and participating in the study in general.

  90 days from randomization

• Video testing on anticoagulation initiation behavior

  The investigators will review charts (electronic medical records) of study participants for frequency of anticoagulation (AC) initiation (switch from being off AC to being on AC) in intervention vs. controls over the six months from randomization in patients who start AC.

  6 months from randomization

• Video testing on anticoagulation persistence behavior

  The investigators will review charts (electronic medical records) of study participants for anticoagulation (AC) persistence (duration of AC use measured in days from baseline) in intervention vs. controls over the six months from randomization in patients who start AC.

  6 months from randomization

Study Arms (2)

Intervention - Patient Videos

EXPERIMENTAL

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.

Behavioral: Storytelling Intervention

Control - Informational Videos (not patients)

NO INTERVENTION

Informational videos about anticoagulation and blood thinners presented by experts or actors.

Interventions

Storytelling Intervention BEHAVIORAL

Participants assigned to the intervention group will watch videos presenting stories of African American patients about their experiences with using anticoagulation or blood thinners throughout a 90-day period.

Intervention - Patient Videos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African-American patients aged 18 or older with elevated stroke risk (CHA2DS2-VASc ≥2 for men and ≥3 for women) who are not currently on anticoagulation (AC) but for whom a cardiology provider or primary care provider at the two study sites recommended AC recently

You may not qualify if:

• Non-African American and other non-Black patients under the age of 18 patients without an ICD-10 diagnostic code consistent with AF or atrial fibrillation or atrial flutter
• Patient without a visit with a primary care provider, cardiovascular medicine specialist, or ambulatory care provider in the previous one year
• Patient who is pregnant or a prisoner.
• Patients with left atrial appendage surgery or device, hospice status, ongoing bleeding, and intracranial bleeding in intralobar territory

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• University of Michigan: collaborator
• University of Florida: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (4)

Luis Ortega Paz

Jacksonville, Florida, 32209, United States

Location

Decentralized

Worcester, Massachusetts, 01655, United States

Location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Medication Adherence; Hemostatic Disorders; Stroke; Hemorrhage; Narration

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Communication

Study Officials

• Alok Kapoor, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 18, 2023
• Study Start: June 24, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)