Storytelling Intervention for Atrial Fibrillation

Enrolling by invitation at 3 trial locations

Overseen By Geoffrey Barnes, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Non-African American, Under 18, Pregnancy, Prisoner, Hospice, Bleeding, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether storytelling can help African American and Black patients with atrial fibrillation, a heart rhythm problem, start and continue taking blood thinners, which reduce the risk of strokes and heart issues. Participants will watch either videos of real patients sharing their experiences (Storytelling Intervention) or informational videos presented by experts. This trial suits African American and Black patients who have been advised by their doctor to start blood thinners but have not yet begun treatment. As an unphased trial, this study offers a unique opportunity to explore innovative ways to support their health journey.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it focuses on patients who are not currently on blood thinners (anticoagulants). It might be best to discuss your current medications with the trial team.

What prior data suggests that this storytelling intervention is safe?

Research shows that storytelling interventions, like those in this trial, use patient stories to share experiences with treatments. Although specific safety data on storytelling itself is lacking, similar methods using video education have helped patients understand atrial fibrillation (a heart condition with irregular heartbeats) and its treatment. These approaches have increased patient knowledge without causing harm.

This trial does not test a new drug or device, so it lacks traditional phases. Instead, it focuses on education and behavior change. As a result, there are no known safety risks from the storytelling itself. Participants will not encounter new medications or physical procedures, which generally means a very low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to helping patients with atrial fibrillation manage their condition through storytelling. Traditional treatments often focus on medications like anticoagulants, which are essential but can be daunting due to potential side effects like bleeding or falls. This trial is unique because it uses personal video stories from African American patients who share their experiences and how they successfully navigated challenges with blood thinners. By providing relatable insights, this method could empower patients and improve adherence to treatment, offering a fresh, supportive angle to standard medical care.

What evidence suggests that the Storytelling Intervention is effective for atrial fibrillation?

Research shows that storytelling can help patients better understand and follow their medication plans. In this trial, participants will join one of two groups. The "Intervention - Patient Videos" group will watch videos of African Americans currently taking anticoagulation, sharing their experiences with using blood thinners and navigating setbacks such as bleeding, falls, strokes, and medication costs. This storytelling approach helps people relate to others' experiences, which is especially helpful for African American and Black patients managing AF. This method encourages the use of blood thinners, potentially reducing the risk of stroke and heart problems. Meanwhile, the "Control - Informational Videos" group will view informational videos about anticoagulation and blood thinners presented by experts or actors. Previous studies have found that using videos to educate people about atrial fibrillation (AF) increased their knowledge of the condition. Additionally, videos and other multimedia tools have improved patient satisfaction and knowledge about blood thinning treatments. ^{1 3 4 6 7}

Who Is on the Research Team?

Alok Kapoor, MD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am an African-American adult with a high stroke risk not on blood thinners, but my doctor recommends starting them.

Exclusion Criteria

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.

Patient who is pregnant or a prisoner

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Call

Verbal informed consent is obtained, and demographic information and health literacy are measured

1 day

1 call (virtual)

Randomization and Intervention

Participants are randomized to watch either storytelling intervention videos or informational videos

6 months

Exit Interview

Conducted approximately 90 days from enrollment to assess AC initiation, barriers, and acceptability

1 day

1 interview (virtual)

Follow-up

Participants are monitored for anticoagulation initiation and persistence, and data is collected for outcome analysis

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Storytelling Intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: Intervention - Patient Videos Experimental Treatment 1 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 Control 1 Intervention

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

Storytelling Intervention is already approved in United States for the following indications:

Approved in United States as K-Talk Intervention for:

• Promotion of HPV Vaccination Uptake

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Providing numeric information about the likelihood of adverse events (AEs) in medications improves risk comprehension among consumers, as shown in a survey of 905 participants, where those given numeric formats were less likely to overestimate risks.

While numeric formats generally increased willingness to use medications, older adults with lower numeracy skills showed less change in their willingness, suggesting that while numeric information is beneficial, its impact may vary by age and numeracy level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Numbers matter to informed patient choices: a randomized design across age and numeracy levels. Peters, E., Hart, PS., Tusler, M., et al.[2022]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

The Knowledge about Atrial Fibrillation and Self-Management (KAFSM) survey has been validated as a reliable tool for measuring patients' knowledge and self-management skills related to atrial fibrillation, based on a study with 383 participants.

The KAFSM survey showed strong content and construct validity, with a high internal consistency reliability score of 0.86, indicating it can effectively assess learning outcomes in AF education programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Psychometric Testing of the Knowledge About Atrial Fibrillation and Self-Management Survey. McCabe, PJ., Sendin, MJ., Stuart-Mullen, L., et al.[2021]

About one-third of the 251 adult patients surveyed at a public hospital clinic had low literacy levels, which significantly impacted their ability to correctly interpret prescription medication warning labels.

Patients with low literacy were 3.4 times less likely to understand these labels correctly, highlighting the need for clearer, simpler warning labels that are easier for all patients to comprehend, especially those with lower literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low literacy impairs comprehension of prescription drug warning labels. Davis, TC., Wolf, MS., Bass, PF., et al.[2022]

An analysis of narratives from 48 breast cancer patients revealed significant differences between how patients describe adverse drug events (ADEs) and the terminology used on pharmaceutical package inserts, indicating a gap in effective communication.

The study suggests that creating an 'Adverse Drug Event Database' with patient narratives could provide valuable, relatable information to help patients better understand and cope with ADEs, which is currently lacking in standard drug information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of an adverse drug event database based on the narrative accounts of patients with breast cancer. Kikuchi, K., Miki, A., Satoh, H., et al.[2020]

A story-based intervention was developed to communicate health information to parents of children with croup, incorporating feedback from parents to ensure the stories were relatable and informative.

Focus group evaluations indicated that parents preferred the story format over traditional medical information sheets, as it made understanding health information easier, although challenges remained in balancing storytelling with evidence-based content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Storytelling as a communication tool for health consumers: development of an intervention for parents of children with croup. Stories to communicate health information. Hartling, L., Scott, S., Pandya, R., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10709770/

Clinician-Created Video Education for Patients With AF

This randomized clinical trial assesses whether clinician-created video-based atrial fibrillation (AF) education is feasible and improves knowledge of AF.

2.

clinicaltrials.gov

clinicaltrials.gov/show/NCT05997914

Storytelling for Reducing Gap in Anticoagulation Use in ...

The overall goal of this study is to evaluate the effectiveness of a previously developed storytelling intervention on anticoagulation (AC) ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40067344/

The Effectiveness of Digital Animation-Based Multistage ...

Methods: This randomized controlled clinical trial included 208 patients with AF who underwent catheter ablation in the Department of Cardiology ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0738399120302445

Effectiveness of multimedia interventions in the provision of ...

Multimedia patient educational interventions on anticoagulation therapy have similar outcomes to traditional methods in knowledge improvement and satisfaction.

5.

nature.com

nature.com/articles/s41746-024-01107-7

Video clips for patient comprehension of atrial fibrillation ...

In this trial, video clip-integrated doctor-patient discharge discussion, improved participants comprehension of AF and DVT and their main complications.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11874357/

Use of digital patient decision-support tools for atrial ...

To assess the effects of digital patient decision-support tools for atrial fibrillation (AF) treatment decisions in adults with AF.

7.

researchprotocols.org

researchprotocols.org/2024/1/e45946

Education of Patients With Atrial Fibrillation and Evaluation ...

Background: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is a leading cause of mortality and morbidity.