Atrial FibrillationNCT05997914
Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation
A study testing Storytelling Intervention in people with Atrial Fibrillation and Atrial Flutter, run by University of Massachusetts, Worcester at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Adherence, Medication
- What is being tested?
- Storytelling Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Jun 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
University of Michigan Medical School
Ann Arbor, Michigan, 48109
Luis Ortega Paz
Jacksonville, Florida, 32209
Decentralized
Worcester, Massachusetts, 01655
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation Randomized Trial (STORY-AF 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.
Read the detailed description
This is a multi-site research study including sites of both the University of Massachusetts Chan Medical School (UMass Memorial Healthcare System) and the University of Michigan Medical Center (Michigan).
Baseline call: During the baseline call, the investigators will obtain verbal informed consent. During the call, the investigators will also collect demographic information and measure health literacy, the latter using two validated single-item instruments the investigators have used before.
Randomization: The investigators will randomize patients to watch videos the investigators developed (intervention) versus informational videos (controls). More specifically, the investigators will randomize patients separately by study site (UMass/Michigan), using randomly permuted blocks of sizes 4 and 6 embedded into a prespecified table.
Exit interview: The exit interview will be conducted approximately 90 days from the date of enrollment with study participants. Interview questions will relate to whether the patient has already started AC, the likelihood of starting anticoagulation (AC), barriers to starting AC, and burdensomeness and acceptability of the interview.
Chart review: The investigators will also perform chart review to capture information that will inform whether the investigators achieved balance in treatment allocation groups on important factors related to study outcomes. Chart review will also provide covariate information which the investigators will use in outcome analysis. Through HIPAA authorization, the investigators will extract information related to age, gender, insurance status, prior AC use, CHA2DS2VASc stroke risk score, comorbidities associated with bleeding, and adherence to preventive health screening.
Data Security: Analyses will be performed using only limited datasets, and only aggregate data will be reported. All data will be used for research purposes only; published data will not contain any individual identifiers and will be reported in the aggregate.
The proposed study involves no more than minimal risk to participants.
The potential benefits to subjects from study participation include increased knowledge of atrial fibrillation and AC and improved rates of adherence to AC guidelines. This may in turn prevent strokes or limit bleeding that would otherwise have occurred without the benefit of this intervention.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Adherence, Medication, Anticoagulants and Bleeding Disorders, Stroke, Bleeding
- Being tested
- Storytelling Intervention
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Medication Adherence, Hemostatic Disorders, Stroke, Hemorrhage, Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storytelling InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Storytelling Intervention |
| Control - Informational Videos (not patients) | No intervention | Informational videos about anticoagulation and blood thinners presented by experts or actors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity via viewing time
Time spent viewing videos
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start24 Jun 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Institute on Minority Health and Health Disparities (NIMHD), University of Florida
- Responsible party
- Principal investigator, Alok Kapoor, University of Massachusetts, Worcester
- Investigators
- Alok Kapoor, MD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997914
- Sponsor's protocol ID
- STUDY00001248
- Other IDs
- R21MD017646
- Status last verified
- Mar 2026
- First submitted
- 25 Jul 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Videos will be shared, but data from individuals watching videos will not be routinely made available. Interested parties can contact the study team.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation Randomized Trial (STORY-AF Trial)
- ClinicalTrials.gov ID
- NCT05997914
- Acronym / sponsor ID
- STUDY00001248
- Conditions
- Atrial Fibrillation, Atrial Flutter, Adherence, Medication, Anticoagulants and Bleeding Disorders, Stroke, Bleeding
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- University of Michigan, National Institute on Minority Health and Health Disparities (NIMHD), University of Florida
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-site research study including sites of both the University of Massachusetts Chan Medical School (UMass Memorial Healthcare System) and the University of Michigan Medical Center (Michigan).
Baseline call: During the baseline call, the investigators will obtain verbal informed consent. During the call, the investigators will also collect demographic information and measure health literacy, the latter using two validated single-item instruments the investigators have used before.
Randomization: The investigators will randomize patients to watch videos the investigators developed (intervention) versus informational videos (controls). More specifically, the investigators will randomize patients separately by study site (UMass/Michigan), using randomly permuted blocks of sizes 4 and 6 embedded into a prespecified table.
Exit interview: The exit interview will be conducted approximately 90 days from the date of enrollment with study participants. Interview questions will relate to whether the patient has already started AC, the likelihood of starting anticoagulation (AC), barriers to starting AC, and burdensomeness and acceptability of the interview.
Chart review: The investigators will also perform chart review to capture information that will inform whether the investigators achieved balance in treatment allocation groups on important factors related to study outcomes. Chart review will also provide covariate information which the investigators will use in outcome analysis. Through HIPAA authorization, the investigators will extract information related to age, gender, insurance status, prior AC use, CHA2DS2VASc stroke risk score, comorbidities associated with bleeding, and adherence to preventive health screening.
Data Security: Analyses will be performed using only limited datasets, and only aggregate data will be reported. All data will be used for research purposes only; published data will not contain any individual identifiers and will be reported in the aggregate.
The proposed study involves no more than minimal risk to participants.
The potential benefits to subjects from study participation include increased knowledge of atrial fibrillation and AC and improved rates of adherence to AC guidelines. This may in turn prevent strokes or limit bleeding that would otherwise have occurred without the benefit of this intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Patient Videos | Experimental | Behavioral: Storytelling InterventionVideos 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. |
| Control - Informational Videos (not patients) | No intervention | –Informational videos about anticoagulation and blood thinners presented by experts or actors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Storytelling InterventionParticipants 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. | Behavioural | Intervention - Patient Videos |
Primary outcome
Fidelity via viewing time
Time frame: 90 days from randomization
Time spent viewing videos
Fidelity via transportation
Time frame: 90 days from randomization
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).
Feasibility in terms of recruitment rates
Time frame: 90 days from randomization
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.
Feasibility in terms of retention rates
Time frame: 90 days from randomization
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.
Acceptability of participating in the study
Time frame: 90 days from randomization
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.
Video testing on anticoagulation initiation behavior
Time frame: 6 months from randomization
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.
Video testing on anticoagulation persistence behavior
Time frame: 6 months from randomization
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. Videos will be shared, but data from individuals watching videos will not be routinely made available. Interested parties can contact the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alok Kapoor, MD principal investigator
UMass Chan Medical School
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storytelling Intervention in people with Atrial Fibrillation and Atrial Flutter, run by University of Massachusetts, Worcester at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity via viewing time (time frame: 90 days from randomization). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.