Storytelling Intervention for Atrial Fibrillation

Recruiting 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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Storytelling Intervention treatment for Atrial Fibrillation?

Storytelling has been shown to be an effective way to communicate health information and engage patients, as seen in its use for parents of children with croup and in rehabilitation for traumatic brain injury. Educational interventions, similar to storytelling, have been effective in improving patient knowledge and perceptions about atrial fibrillation and anticoagulant therapy, suggesting that storytelling could also be beneficial in this context. ^{1 2 3 4 5}

Is the Storytelling Intervention safe for humans?

There is no specific safety data available for the Storytelling Intervention or its variations, but it's important for researchers to carefully assess and report any adverse events (unintended negative effects) in psychological interventions to ensure they are safe. ^{6 7 8 9 10}

How is the Storytelling Intervention treatment for atrial fibrillation different from other treatments?

The Storytelling Intervention for atrial fibrillation is unique because it uses storytelling, a method often used in rehabilitation for other conditions like traumatic brain injury, to educate and engage patients, potentially improving their understanding and management of the condition in a more relatable and personal way compared to traditional medical treatments. ^{3 5 11 12 13}

Research Team

Alok Kapoor, MD

Principal Investigator

UMass Chan Medical School

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Patient knowledge and perceptions of atrial fibrillation and anticoagulant therapy: effects of an educational intervention programme. The West Birmingham Atrial Fibrillation Project. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Storytelling as an intervention in traumatic brain injury rehabilitation: a scoping review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Protocol of a clinical trial study involving educational intervention in patients treated with warfarin. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

A Randomised Controlled Trial on the Effect of Nurse-Led Educational Intervention at the Time of Catheter Ablation for Atrial Fibrillation on Quality of Life, Symptom Severity and Rehospitalisation. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Low literacy impairs comprehension of prescription drug warning labels. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Educational and information needs of patients under vitamin K antagonist therapy]. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Numbers matter to informed patient choices: a randomized design across age and numeracy levels. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

Utility of an adverse drug event database based on the narrative accounts of patients with breast cancer. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

11. England pubmed.ncbi.nlm.nih.gov

The information needs of patients with atrial fibrillation: A scoping review. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Atrial fibrillation: the newest frontier in arrhythmia management. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Initial Psychometric Testing of the Knowledge About Atrial Fibrillation and Self-Management Survey. [2021]