xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05997914</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00001248</org_study_id>
      <nct_id>NCT05997914</nct_id>
    </id_info>
    <brief_title>Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation</brief_title>
    <official_title>Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation Randomized Trial (STORY-AF Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Massachusetts, Worcester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Massachusetts, Worcester</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The overall goal of this study is to evaluate the effectiveness of a previously developed&#xD;
        storytelling intervention on anticoagulation (AC) initiation/persistence in African American&#xD;
        and Black patients with atrial fibrillation/flutter. The investigators hope to gain knowledge&#xD;
        that may help treat atrial fibrillation or flutter and lower stroke and adverse&#xD;
        cardiovascular event risks for African American and Black patients by increasing the use of&#xD;
        blood thinning medications known as anticoagulants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-site research study including sites of both the University of Massachusetts&#xD;
        Chan Medical School (UMass Memorial Healthcare System) and the University of Michigan Medical&#xD;
        Center (Michigan).&#xD;
  &#xD;
        Baseline call: During the baseline call, the investigators will obtain verbal informed&#xD;
        consent. During the call, the investigators will also collect demographic information and&#xD;
        measure health literacy, the latter using two validated single-item instruments the&#xD;
        investigators have used before.&#xD;
  &#xD;
        Randomization: The investigators will randomize patients to watch videos the investigators&#xD;
        developed (intervention) versus informational videos (controls). More specifically, the&#xD;
        investigators will randomize patients separately by study site (UMass/Michigan), using&#xD;
        randomly permuted blocks of sizes 4 and 6 embedded into a prespecified table.&#xD;
  &#xD;
        Exit interview: The exit interview will be conducted approximately 90 days from the date of&#xD;
        enrollment with study participants. Interview questions will relate to whether the patient&#xD;
        has already started AC, the likelihood of starting anticoagulation (AC), barriers to starting&#xD;
        AC, and burdensomeness and acceptability of the interview.&#xD;
  &#xD;
        Chart review: The investigators will also perform chart review to capture information that&#xD;
        will inform whether the investigators achieved balance in treatment allocation groups on&#xD;
        important factors related to study outcomes. Chart review will also provide covariate&#xD;
        information which the investigators will use in outcome analysis. Through HIPAA&#xD;
        authorization, the investigators will extract information related to age, gender, insurance&#xD;
        status, prior AC use, CHA2DS2VASc stroke risk score, comorbidities associated with bleeding,&#xD;
        and adherence to preventive health screening.&#xD;
  &#xD;
        Data Security: Analyses will be performed using only limited datasets, and only aggregate&#xD;
        data will be reported. All data will be used for research purposes only; published data will&#xD;
        not contain any individual identifiers and will be reported in the aggregate.&#xD;
  &#xD;
        The proposed study involves no more than minimal risk to participants.&#xD;
  &#xD;
        The potential benefits to subjects from study participation include increased knowledge of&#xD;
        atrial fibrillation and AC and improved rates of adherence to AC guidelines. This may in turn&#xD;
        prevent strokes or limit bleeding that would otherwise have occurred without the benefit of&#xD;
        this intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2026</completion_date>
    <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fidelity via viewing time</measure>
      <time_frame>90 days from randomization</time_frame>
      <description>Time spent viewing videos</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fidelity via transportation</measure>
      <time_frame>90 days from randomization</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility in terms of recruitment rates</measure>
      <time_frame>90 days from randomization</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility in terms of retention rates</measure>
      <time_frame>90 days from randomization</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of participating in the study</measure>
      <time_frame>90 days from randomization</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Video testing on anticoagulation initiation behavior</measure>
      <time_frame>6 months from randomization</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Video testing on anticoagulation persistence behavior</measure>
      <time_frame>6 months from randomization</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Atrial Fibrillation</condition>
    <condition>Atrial Flutter</condition>
    <condition>Adherence, Medication</condition>
    <condition>Anticoagulants and Bleeding Disorders</condition>
    <condition>Stroke</condition>
    <condition>Bleeding</condition>
    <condition>Narration</condition>
    <arm_group>
      <arm_group_label>Intervention - Patient Videos</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control - Informational Videos (not patients)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Informational videos about anticoagulation and blood thinners presented by experts or actors.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Storytelling Intervention</intervention_name>
      <description>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.</description>
      <arm_group_label>Intervention - Patient Videos</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  African-American patients aged 18 or older with elevated stroke risk (CHA2DS2-VASc ≥2&#xD;
               for men and ≥3 for women) who are not currently on anticoagulation (AC) but for whom a&#xD;
               cardiology provider or primary care provider at the two study sites recommended AC&#xD;
               recently&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-African American and other non-Black patients under the age of 18 patients without&#xD;
               an ICD-10 diagnostic code consistent with AF or atrial fibrillation or atrial flutter&#xD;
  &#xD;
            -  Patient without a visit with a primary care provider, cardiovascular medicine&#xD;
               specialist, or ambulatory care provider in the previous one year&#xD;
  &#xD;
            -  Patient who is pregnant or a prisoner.&#xD;
  &#xD;
            -  Patients with left atrial appendage surgery or device, hospice status, ongoing&#xD;
               bleeding, and intracranial bleeding in intralobar territory&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alok Kapoor, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UMass Chan Medical School</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alok Kapoor, MD</last_name>
      <phone>508-441-3562</phone>
      <phone_ext>1</phone_ext>
      <email>alok.kapoor@umassmemorial.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>UMass Chan Medical School</name>
        <address>
          <city>Worcester</city>
          <state>Massachusetts</state>
          <zip>01655</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alok Kapoor, MD</last_name>
        <phone>508-441-3562</phone>
        <phone_ext>1</phone_ext>
        <email>alok.kapoor@umassmemorial.org</email>
      </contact>
      <investigator>
        <last_name>Alok Kapoor, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Michigan Medical School</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Geoffrey Barnes, MD, MSc</last_name>
        <email>gbarnes@umich.edu</email>
      </contact>
      <investigator>
        <last_name>Geoffrey Barnes, MD, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
      <investigator_full_name>Alok Kapoor</investigator_full_name>
      <investigator_title>Associate Professor of Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
      <mesh_term>Atrial Flutter</mesh_term>
      <mesh_term>Hemostatic Disorders</mesh_term>
      <mesh_term>Blood Coagulation Disorders</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05997914
  org study id: STUDY00001248
  nct id: NCT05997914
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Fidelity via viewing time
  time frame: 90 days from randomization
  description: Time spent viewing videos
  measure: Fidelity via transportation
  time frame: 90 days from randomization
  description: 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).
  measure: Feasibility in terms of recruitment rates
  time frame: 90 days from randomization
  description: 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.
  measure: Feasibility in terms of retention rates
  time frame: 90 days from randomization
  description: 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.
  measure: Acceptability of participating in the study
  time frame: 90 days from randomization
  description: 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.
  measure: Video testing on anticoagulation initiation behavior
  time frame: 6 months from randomization
  description: 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.
  measure: Video testing on anticoagulation persistence behavior
  time frame: 6 months from randomization
  description: 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.
  arm group label: Intervention - Patient Videos
  arm group type: Experimental
  description: 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.
  arm group label: Control - Informational Videos (not patients)
  arm group type: No Intervention
  description: Informational videos about anticoagulation and blood thinners presented by experts or actors.
  intervention type: Behavioral
  intervention name: Storytelling Intervention
  description: 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.
  arm group label: Intervention - Patient Videos
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alok Kapoor, MD
  role: Principal Investigator
  affiliation: UMass Chan Medical School
  last name: Alok Kapoor, MD
  phone: 508-441-3562
  phone ext: 1
  email: alok.kapoor@umassmemorial.org
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Massachusetts, Worcester
  investigator full name: Alok Kapoor
  investigator title: Associate Professor of Medicine
  mesh term: Atrial Fibrillation
  mesh term: Atrial Flutter
  mesh term: Hemostatic Disorders
  mesh term: Blood Coagulation Disorders
  mesh term: Hemorrhage