<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/NCT03018197</url>
  </required_header>
  <id_info>
    <org_study_id>PRC13-0806 ePHR AFib pilot</org_study_id>
    <nct_id>NCT03018197</nct_id>
  </id_info>
  <brief_title>Use of Electronic Personal Health Records to Improve Medication Adherence</brief_title>
  <official_title>The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parkview Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Medicare and Medicaid Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Parkview Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to examine the use of a personal health record to improve&#xD;
      medication adherence among patients with non-valvular atrial fibrillation taking dabigatran&#xD;
      for primary prevention of embolic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three brief newsletters will be sent by the research staff to the study patients in the form&#xD;
      of secure messages through their MyChart account. The newsletters will describe dabigatran&#xD;
      tolerability, adverse effects, patient monitoring, warnings/precautions, and administration.&#xD;
      Newsletters will be developed through a review of the FDA-approved prescribing information,&#xD;
      general tertiary references, and a search of PubMed and drafted with guidance from a Drug&#xD;
      Information Specialist at Manchester University College of Pharmacy as well as reviewed by&#xD;
      the research staff.&#xD;
&#xD;
      Descriptive analysis will be used to analyze the survey to assess patient attitudes and&#xD;
      beliefs about dabigatran and personal health records, as well as to assess the level of&#xD;
      patient engagement. Difference-in-difference regression analysis will be used to evaluate the&#xD;
      impact of the personal health record on dabigatran adherence by comparing the differences&#xD;
      between times (pre-post) and interventions. Patient medication adherence will be correlated&#xD;
      from the Pharmacy refill data to determine if the Intervention Group is more compliant than&#xD;
      the Control Group. Multivariate analysis will be used to explore factors influencing personal&#xD;
      health record use and dabigatran adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medication Adherence evaluated through medication possession ratios</measure>
    <time_frame>3 months during study</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Engagement evaluated through Patient Activation Measure (PAM)</measure>
    <time_frame>3 months during study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Knowledge evaluated through 5-question survey</measure>
    <time_frame>3 months during study</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Medication Adherence</condition>
  <arm_group>
    <arm_group_label>Medication Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive training on the use of the personal health record and health education via the personal health record.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Medication Education</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive the current standard of care for the personal health record. Patients will not receive training on the use of the personal health record or health education via the personal health record.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medication Education</intervention_name>
    <description>Medication education delivered via the personal health record (MyChart) pertinent to the anticoagulation medication dabigatran. Education newsletters will be sent at 4, 6, and 10 weeks post-enrollment.</description>
    <arm_group_label>Medication Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Patient of Parkview Physicians Group-Cardiology&#xD;
&#xD;
          -  Currently on dabigatran for non-valvular atrial fibrillation&#xD;
&#xD;
          -  Out-patient status&#xD;
&#xD;
          -  Ability to read and understand English&#xD;
&#xD;
          -  Access to the Internet&#xD;
&#xD;
          -  Ability to utilize the computer and Internet&#xD;
&#xD;
          -  Willingness to enroll in a MyChart account&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical or cognitive disability hindering provision of the informed consent process&#xD;
             or performance of study tasks&#xD;
&#xD;
          -  Unable to physically or cognitively carry out the tasks necessary for activating&#xD;
             and/or utilizing a personal health record&#xD;
&#xD;
          -  Designated as part of a vulnerable subject population that the investigator or&#xD;
             designee identifies to have compromised autonomy related to potential study&#xD;
             participation&#xD;
&#xD;
          -  Currently part of another study involving another type of personal health record&#xD;
             (other than MyChart)&#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>Michael Mirro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parkview Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ozlem Ersin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Manchester University College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkview Research Center; Parkview Health</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Parkview Health</investigator_affiliation>
    <investigator_full_name>Michael Mirro</investigator_full_name>
    <investigator_title>Chief Academic and Research Officer</investigator_title>
  </responsible_party>
  <keyword>Personal Health Record</keyword>
  <keyword>Medication Knowledge</keyword>
  <keyword>Anticoagulants</keyword>
  <keyword>Patient Engagement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available.</ipd_description>
  </patient_data>
  <!-- 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/NCT03018197
org study id: PRC13-0806 ePHR AFib pilot
nct id: NCT03018197
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this pilot study is to examine the use of a personal health record to improve
      medication adherence among patients with non-valvular atrial fibrillation taking dabigatran
      for primary prevention of embolic stroke.
Three brief newsletters will be sent by the research staff to the study patients in the form
      of secure messages through their MyChart account. The newsletters will describe dabigatran
      tolerability, adverse effects, patient monitoring, warnings/precautions, and administration.
      Newsletters will be developed through a review of the FDA-approved prescribing information,
      general tertiary references, and a search of PubMed and drafted with guidance from a Drug
      Information Specialist at Manchester University College of Pharmacy as well as reviewed by
      the research staff.

      Descriptive analysis will be used to analyze the survey to assess patient attitudes and
      beliefs about dabigatran and personal health records, as well as to assess the level of
      patient engagement. Difference-in-difference regression analysis will be used to evaluate the
      impact of the personal health record on dabigatran adherence by comparing the differences
      between times (pre-post) and interventions. Patient medication adherence will be correlated
      from the Pharmacy refill data to determine if the Intervention Group is more compliant than
      the Control Group. Multivariate analysis will be used to explore factors influencing personal
      health record use and dabigatran adherence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Medication Adherence evaluated through medication possession ratios
time frame: 3 months during study
measure: Patient Engagement evaluated through Patient Activation Measure (PAM)
time frame: 3 months during study
measure: Medication Knowledge evaluated through 5-question survey
time frame: 3 months during study
arm group label: Medication Education
arm group type: Experimental
description: Patients will receive training on the use of the personal health record and health education via the personal health record.
arm group label: No Medication Education
arm group type: No Intervention
description: Patients will receive the current standard of care for the personal health record. Patients will not receive training on the use of the personal health record or health education via the personal health record.
intervention type: Other
intervention name: Medication Education
description: Medication education delivered via the personal health record (MyChart) pertinent to the anticoagulation medication dabigatran. Education newsletters will be sent at 4, 6, and 10 weeks post-enrollment.
arm group label: Medication Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Mirro, MD
role: Principal Investigator
affiliation: Parkview Health
last name: Ozlem Ersin, PhD
role: Principal Investigator
affiliation: Manchester University College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Parkview Health
investigator full name: Michael Mirro
investigator title: Chief Academic and Research Officer
mesh term: Atrial Fibrillation
sharing ipd: No
ipd description: There is no plan to make individual participant data available.