<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/NCT02996435</url>
  </required_header>
  <id_info>
    <org_study_id>CR108260</org_study_id>
    <secondary_id>39039039AFL4010</secondary_id>
    <nct_id>NCT02996435</nct_id>
  </id_info>
  <brief_title>Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation</brief_title>
  <official_title>smartADHERE - Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Scientific Affairs, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Scientific Affairs, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to evaluate the effectiveness of an intervention with a&#xD;
      mobile adherence platform, compared to physician- or nurse-guided standard of care, to&#xD;
      improve medication adherence to rivaroxaban in participants who have recently initiated&#xD;
      treatment with rivaroxaban for stroke prevention in atrial fibrillation based on an&#xD;
      assessment of the proportion of days covered (PDC) of rivaroxaban treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2016</start_date>
  <completion_date type="Actual">March 22, 2018</completion_date>
  <primary_completion_date type="Actual">March 22, 2018</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Days Covered (PDC)</measure>
    <time_frame>Month 6</time_frame>
    <description>Adherence to rivaroxaban medication will be estimated based on validated PDC algorithm. PDC (expressed as percentage) defined as non-hospitalized days during which oral anticoagulant (OAC) will be supplied and consumed over total observation time duration during which rivaroxaban should have been consumed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With PDC Greater Than or Equal to (&gt;=) 80 Percent</measure>
    <time_frame>Month 6</time_frame>
    <description>PDC defined as non-hospitalized days during which oral anticoagulant (OAC) will be supplied and consumed over total observation time duration during which rivaroxaban should have been consumed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Average Score on the Eight-item Morisky Medication Adherence Scale (MMAS-8)</measure>
    <time_frame>Month 6</time_frame>
    <description>The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Medication Persistence of Rivaroxaban</measure>
    <time_frame>Month 6</time_frame>
    <description>Measure of medication persistence of rivaroxaban defined as the percentage of participants on rivaroxaban with an active prescription at 6 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Mobile Adherence Platform</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant adherence will be monitored using a mobile application and platform which provides a real-time reminder that alerts the participant to take his or her medication. The application will also send an alert to the participant when a refill is needed based on calculated medication or pill supply. The intervention will focus only on daily adherence to rivaroxaban.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: Standard of Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will receive physician- or nurse-guided standard of care for their rivaroxaban adherence. No drug will be administered as part of this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Application Intervention</intervention_name>
    <description>Mobile phone application that sends reminders and allows participants to self-manage their medication adherence. Monitoring of participant adherence from this tool will be performed by the central coordinating center, which will send notifications or contact the participant based on the adherence history in accordance with the study protocol.</description>
    <arm_group_label>Mobile Adherence Platform</arm_group_label>
    <other_name>Care4Today®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>Participants will receive physician- or nurse-guided standard of care.</description>
    <arm_group_label>Control: Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A history of atrial fibrillation&#xD;
&#xD;
          -  Taking newly-prescribed rivaroxaban for atrial fibrillation for less than or equal to&#xD;
             (&lt;=) 90 days or who are about to initiate therapy (with a prescription dated in the&#xD;
             last 90 days)&#xD;
&#xD;
          -  At least 1 of the 4 questions answered &quot;yes&quot; from the four-item Morisky Medication&#xD;
             Adherence Scale (MMAS-4)&#xD;
&#xD;
          -  Possession of a compatible smartphone with an active phone number, text and data plan.&#xD;
             The smartphone must be in continued possession of the participant. It may not be a&#xD;
             shared device and must exclusively remain in the possession of the participant during&#xD;
             the study period. The smartphone must have an active cellular phone number and&#xD;
             cellular data subscription. WiFi internet capability is not a substitute for an active&#xD;
             cellular data plan&#xD;
&#xD;
          -  Willing to have the adherence application installed on a smartphone and use it every&#xD;
             day during the entire study period&#xD;
&#xD;
          -  Must sign an informed consent form (ICF) indicating that he or she understands the&#xD;
             purpose of, and procedures required for, the study and is willing to participate in&#xD;
             the study and is willing to authorize the study team to contact the participant's&#xD;
             pharmacy for oral anticoagulation medication and refill data&#xD;
&#xD;
          -  Willing to provide oral confirmation indicating that he/she has not previously used a&#xD;
             medication adherence application&#xD;
&#xD;
          -  Ability to read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anticipated inability to adhere to the mobile application (Care4Today) based on&#xD;
             opinion of site Principal Investigator (PI)&#xD;
&#xD;
          -  Anticipated rivaroxaban use less than (&lt;) 12 months based on clinical documentation or&#xD;
             participant interview&#xD;
&#xD;
          -  Prescribed rivaroxaban for indications other than atrial fibrillation (Prescriptions&#xD;
             for concomitant conditions are allowed as long as 1 of the indications is atrial&#xD;
             fibrillation)&#xD;
&#xD;
          -  Current use of: specialized anticoagulation clinics for rivaroxaban medication&#xD;
             management; specialized pharmacist-led adherence or refill monitoring; or enrollment&#xD;
             in a medication adherence program even if that program is for medications other than&#xD;
             rivaroxaban&#xD;
&#xD;
          -  Current use of adherence tracking devices, hardware, smartphone or computer&#xD;
             applications, including but not limited to smart pill bottles, pill timers,&#xD;
             radiofrequency tagged medications or dispensers, mobile applications, or automated&#xD;
             phone reminders. Pharmacy and health care plan automated refill reminders are&#xD;
             permitted and are not exclusion. Pill organizers or containers that only&#xD;
             compartmentalize a participant's medications based on days of the week are not&#xD;
             exclusion. Pill organizers that remind participants when to take medicine with beeps&#xD;
             or alerts are exclusion&#xD;
&#xD;
          -  Cognitive, visual, hearing, voice, or motor impairment that would prevent completion&#xD;
             of study procedures or use of mobile phone&#xD;
&#xD;
          -  Employee of the investigator or study site, with direct involvement in the proposed&#xD;
             study or other studies under the direction of that investigator or study site, as well&#xD;
             as family members of the employees or the investigator&#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>Janssen Scientific Affairs, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Scientific Affairs, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manhattan Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Joseph</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jamaica</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saratoga Springs</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Doylestown</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reading</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yardley</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>October 25, 2018</last_update_submitted>
  <last_update_submitted_qc>October 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02996435
org study id: CR108260
secondary id: 39039039AFL4010
nct id: NCT02996435
lead sponsor: 
has dmc: No
The primary purpose of this study is to evaluate the effectiveness of an intervention with a
      mobile adherence platform, compared to physician- or nurse-guided standard of care, to
      improve medication adherence to rivaroxaban in participants who have recently initiated
      treatment with rivaroxaban for stroke prevention in atrial fibrillation based on an
      assessment of the proportion of days covered (PDC) of rivaroxaban treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Proportion of Days Covered (PDC)
time frame: Month 6
description: Adherence to rivaroxaban medication will be estimated based on validated PDC algorithm. PDC (expressed as percentage) defined as non-hospitalized days during which oral anticoagulant (OAC) will be supplied and consumed over total observation time duration during which rivaroxaban should have been consumed.
measure: Percentage of Participants With PDC Greater Than or Equal to (>=) 80 Percent
time frame: Month 6
description: PDC defined as non-hospitalized days during which oral anticoagulant (OAC) will be supplied and consumed over total observation time duration during which rivaroxaban should have been consumed.
measure: Change From Baseline in the Average Score on the Eight-item Morisky Medication Adherence Scale (MMAS-8)
time frame: Month 6
description: The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation.
measure: Measure of Medication Persistence of Rivaroxaban
time frame: Month 6
description: Measure of medication persistence of rivaroxaban defined as the percentage of participants on rivaroxaban with an active prescription at 6 months.
arm group label: Mobile Adherence Platform
arm group type: Experimental
description: Participant adherence will be monitored using a mobile application and platform which provides a real-time reminder that alerts the participant to take his or her medication. The application will also send an alert to the participant when a refill is needed based on calculated medication or pill supply. The intervention will focus only on daily adherence to rivaroxaban.
arm group label: Control: Standard of Care
arm group type: Other
description: Participants will receive physician- or nurse-guided standard of care for their rivaroxaban adherence. No drug will be administered as part of this study.
intervention type: Behavioral
intervention name: Mobile Application Intervention
description: Mobile phone application that sends reminders and allows participants to self-manage their medication adherence. Monitoring of participant adherence from this tool will be performed by the central coordinating center, which will send notifications or contact the participant based on the adherence history in accordance with the study protocol.
arm group label: Mobile Adherence Platform
other name: Care4Today®
intervention type: Other
intervention name: No Intervention
description: Participants will receive physician- or nurse-guided standard of care.
arm group label: Control: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Scientific Affairs, LLC Clinical Trial
role: Study Director
affiliation: Janssen Scientific Affairs, LLC
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country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation