<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/NCT04439864</url>
  </required_header>
  <id_info>
    <org_study_id>2013-0802</org_study_id>
    <secondary_id>P30AG022849</secondary_id>
    <secondary_id>UL1TR000050</secondary_id>
    <secondary_id>P30NR010680</secondary_id>
    <nct_id>NCT04439864</nct_id>
  </id_info>
  <brief_title>Perspectives Patient Education Randomized Study</brief_title>
  <official_title>Perspectives Post Percutaneous Coronary Intervention Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cook County Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</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>
      This is a randomized clinical trial evaluating the educational program called My&#xD;
      Interventional Drug Eluting Stent Educational App (MyIDEA) that is a pilot at two sites.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2014</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of study design engaging elderly patients in novel tablet based education.</measure>
    <time_frame>3 months</time_frame>
    <description>Would research participants enroll and follow up in a study of tablet based education. Do patients think they know everything? Would patients enrolled in the control arm still follow up in the study?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>3 months</time_frame>
    <description>A measure of Pharmacy days covered for DAPT medication. The patients after recieving a Drug Eluting Stent need to adhere to Dual Antiplatlet Therapy (DAPT) to prevent restenosis of the stent. PDC is a calculation of the DAPT which is Aspirin and an ADP receptor antagonist. As aspirin is over the counter, the pharmacy does not have a record of purchase so the PDC was calculated for the ADP receptor antagonis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Medication Adherence</condition>
  <arm_group>
    <arm_group_label>MyIDEA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Research Participants interacted with MyIDEA program both in the hospital and in the follow up cardiology appointment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as normal</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The research participants were given the chance to play games on the tablet and received normal clinical education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MyIDEA</intervention_name>
    <description>An educational tablet app that is customized to the patient based on the data in the Electronic Health Record.</description>
    <arm_group_label>MyIDEA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. received a drug eluting stent during a Percutaneous Coronary Intervention (PCI) during&#xD;
             a hospitalization for the PCI procedure,&#xD;
&#xD;
          2. were greater than 50 years old (funding agency requirement),&#xD;
&#xD;
          3. spoke and understood English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. inability to give informed consent&#xD;
&#xD;
          2. allergy to aspirin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew D Boyd, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <reference>
    <citation>Shah V, Dileep A, Dickens C, Groo V, Welland B, Field J, Baumann M, Flores JD, Shroff A, Zhao Z, Yao Y, Wilkie DJ, Boyd AD. Patient-Centered Tablet Application for Improving Medication Adherence after a Drug-Eluting Stent. Front Public Health. 2016 Dec 12;4:272. doi: 10.3389/fpubh.2016.00272. eCollection 2016.</citation>
    <PMID>28018897</PMID>
  </reference>
  <results_reference>
    <citation>Boyd AD, Moores K, Shah V, Sadhu E, Shroff A, Groo V, Dickens C, Field J, Baumann M, Welland B, Gutowski G, Flores JD Jr, Zhao Z, Bahroos N, Hynes DM, Wilkie DJ. My Interventional Drug-Eluting Stent Educational App (MyIDEA): Patient-Centered Design Methodology. JMIR Mhealth Uhealth. 2015 Jul 2;3(3):e74. doi: 10.2196/mhealth.4021.</citation>
    <PMID>26139587</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Andrew D Boyd</investigator_full_name>
    <investigator_title>Association Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04439864
org study id: 2013-0802
secondary id: P30AG022849
secondary id: UL1TR000050
secondary id: P30NR010680
nct id: NCT04439864
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized clinical trial evaluating the educational program called My
      Interventional Drug Eluting Stent Educational App (MyIDEA) that is a pilot at two sites.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Feasibility of study design engaging elderly patients in novel tablet based education.
time frame: 3 months
description: Would research participants enroll and follow up in a study of tablet based education. Do patients think they know everything? Would patients enrolled in the control arm still follow up in the study?
measure: Medication adherence
time frame: 3 months
description: A measure of Pharmacy days covered for DAPT medication. The patients after recieving a Drug Eluting Stent need to adhere to Dual Antiplatlet Therapy (DAPT) to prevent restenosis of the stent. PDC is a calculation of the DAPT which is Aspirin and an ADP receptor antagonist. As aspirin is over the counter, the pharmacy does not have a record of purchase so the PDC was calculated for the ADP receptor antagonis.
arm group label: MyIDEA
arm group type: Experimental
description: Research Participants interacted with MyIDEA program both in the hospital and in the follow up cardiology appointment.
arm group label: Treatment as normal
arm group type: No Intervention
description: The research participants were given the chance to play games on the tablet and received normal clinical education.
intervention type: Device
intervention name: MyIDEA
description: An educational tablet app that is customized to the patient based on the data in the Electronic Health Record.
arm group label: MyIDEA
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew D Boyd, MD
role: Principal Investigator
affiliation: University of Illinois at Chicago
citation: Shah V, Dileep A, Dickens C, Groo V, Welland B, Field J, Baumann M, Flores JD, Shroff A, Zhao Z, Yao Y, Wilkie DJ, Boyd AD. Patient-Centered Tablet Application for Improving Medication Adherence after a Drug-Eluting Stent. Front Public Health. 2016 Dec 12;4:272. doi: 10.3389/fpubh.2016.00272. eCollection 2016.
PMID: 28018897
citation: Boyd AD, Moores K, Shah V, Sadhu E, Shroff A, Groo V, Dickens C, Field J, Baumann M, Welland B, Gutowski G, Flores JD Jr, Zhao Z, Bahroos N, Hynes DM, Wilkie DJ. My Interventional Drug-Eluting Stent Educational App (MyIDEA): Patient-Centered Design Methodology. JMIR Mhealth Uhealth. 2015 Jul 2;3(3):e74. doi: 10.2196/mhealth.4021.
PMID: 26139587
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Andrew D Boyd
investigator title: Association Professor
sharing ipd: No