<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/NCT03022669</url>
  </required_header>
  <id_info>
    <org_study_id>NRI 15-455</org_study_id>
    <nct_id>NCT03022669</nct_id>
  </id_info>
  <brief_title>Mobile Health Strategies for Veterans</brief_title>
  <official_title>Mobile Health Strategies for Veterans With Coronary Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Francisco Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>John Muir Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Florida/South Georgia Veterans Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Texas Veterans Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>VA Palo Alto Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>San Francisco Veterans Affairs Medical Center</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 purpose of this study is to determine whether text messages/messaging (TM) or a mobile&#xD;
      application (app), compared with an educational website-control provided to all Veterans, can&#xD;
      improve adherence to antiplatelet therapy among patients following acute coronary syndrome or&#xD;
      percutaneous coronary intervention (ACS/PCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adherence to antiplatelet medications is critical to prevent life threatening complications&#xD;
      (i.e., stent thrombosis); yet rates of non-adherence range from 21-57% by 12 months. Mobile&#xD;
      technology through TM or mobile apps is a practical and inexpensive strategy to promote&#xD;
      behavior change and enhance medication adherence. The three specific aims of this proposal&#xD;
      are to: 1) determine preferences for content and frequency of TM to promote medication&#xD;
      adherence through focus groups; 2) determine the most patient-centered app to promote&#xD;
      adherence through a content analysis of all commercially available apps for medication&#xD;
      adherence and focus groups centered on usability; and 3) compare adherence to antiplatelet&#xD;
      medications in 225 Veterans post ACS/PCI through a randomized controlled trial. Participants&#xD;
      will be randomized to either TM, mobile app, or website-control group. The focus groups will&#xD;
      be stratified by low/high mobile phone use and sex.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2022</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in medication adherence over 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Medication Event Monitoring System (MEMS) which is an electronic pill bottle cap that captures medication taking patterns</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in medication adherence over 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Adherence to Refills and Medications Scale (ARMS)- There are two subscale scores for medication taking and medication refills. The total score is found by adding both subscales. Scores can range from 12 to 48 with 12 being completely medication adherent and 48 being completely non-adherent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in medication adherence at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Medication recall questionnaire that will assess how many missed doses there were.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in medication adherence at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>VA Corporate Data Warehouse refill data (Veteran participants)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in medication adherence at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Peoplechart Meds Incontext refill data (non-Veteran participants)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">225</enrollment>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>Text Message Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The &quot;TM group&quot; will use the VA &quot;Annie&quot; text messaging program to remind patients to take antiplatelet medications. The content for the text messages will be determined through preliminary focus groups that will be conducted prior to the RCT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Application Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The &quot;App group&quot; will use a mobile application to remind patients to take antiplatelet medications. The commercially available mobile app will be selected by participants through preliminary focus groups that will be conducted prior to the RCT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Website-Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The &quot;Website-Control group&quot; will will be offered the American Heart Association patient education website (My Life Check - 7 Steps To Healthy Living) and will serve as an &quot;attention-control.&quot; The website will be offered to participants in all three groups. The &quot;7 small steps to big changes&quot; are to manage blood pressure, control cholesterol, reduce blood sugar, get active, eat better, lose weight, and stop smoking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text Message</intervention_name>
    <description>Annie (VA text messaging program) or mobile Health manager (private text messaging program for non-VA female participants recruited at non-VA facility)</description>
    <arm_group_label>Text Message Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Application</intervention_name>
    <arm_group_label>Application Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Website</intervention_name>
    <description>American Heart Association patient education website</description>
    <arm_group_label>Application Group</arm_group_label>
    <arm_group_label>Text Message Group</arm_group_label>
    <arm_group_label>Website-Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 21 years of age,&#xD;
&#xD;
          -  recent ACS or PCI within 1 week&#xD;
&#xD;
          -  new antiplatelet (thienopyridine) prescription&#xD;
&#xD;
          -  owns a smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment&#xD;
&#xD;
          -  lack of English proficiency/literacy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda Park, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Francisco Veterans Medical Center; University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Linda Park, PhD, MS, FNP</last_name>
    <email>Linda.Park@ucsf.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julia von Oppenfeld</last_name>
    <phone>415-676-1153</phone>
    <email>Julia.vonOppenfeld@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>John Muir Medical Center</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia von Oppenfeld</last_name>
      <phone>415-676-1153</phone>
      <email>Julia.vonOppenfeld@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia von Oppenfeld</last_name>
      <phone>415-676-1153</phone>
      <email>Julia.vonOppenfeld@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>San Francisco Veterans Affairs Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia von Oppenfeld</last_name>
      <phone>415-676-1153</phone>
      <email>Julia.vonOppenfeld@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>North Florida/South Georgia Veterans Health System</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia von Oppenfeld</last_name>
      <phone>415-676-1153</phone>
      <email>Julia.vonOppenfeld@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>VA North Texas Health Care System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia von Oppenfeld</last_name>
      <phone>415-676-1153</phone>
      <email>Julia.vonOppenfeld@va.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Linda Park</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>mobile health</keyword>
  <keyword>veterans</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>medication adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03022669
org study id: NRI 15-455
nct id: NCT03022669
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether text messages/messaging (TM) or a mobile
      application (app), compared with an educational website-control provided to all Veterans, can
      improve adherence to antiplatelet therapy among patients following acute coronary syndrome or
      percutaneous coronary intervention (ACS/PCI).
Adherence to antiplatelet medications is critical to prevent life threatening complications
      (i.e., stent thrombosis); yet rates of non-adherence range from 21-57% by 12 months. Mobile
      technology through TM or mobile apps is a practical and inexpensive strategy to promote
      behavior change and enhance medication adherence. The three specific aims of this proposal
      are to: 1) determine preferences for content and frequency of TM to promote medication
      adherence through focus groups; 2) determine the most patient-centered app to promote
      adherence through a content analysis of all commercially available apps for medication
      adherence and focus groups centered on usability; and 3) compare adherence to antiplatelet
      medications in 225 Veterans post ACS/PCI through a randomized controlled trial. Participants
      will be randomized to either TM, mobile app, or website-control group. The focus groups will
      be stratified by low/high mobile phone use and sex.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in medication adherence over 12 months
time frame: 12 months
description: Medication Event Monitoring System (MEMS) which is an electronic pill bottle cap that captures medication taking patterns
measure: Change in medication adherence over 12 months
time frame: 12 months
description: Adherence to Refills and Medications Scale (ARMS)- There are two subscale scores for medication taking and medication refills. The total score is found by adding both subscales. Scores can range from 12 to 48 with 12 being completely medication adherent and 48 being completely non-adherent.
measure: Change in medication adherence at 12 months
time frame: 12 months
description: Medication recall questionnaire that will assess how many missed doses there were.
measure: Change in medication adherence at 12 months
time frame: 12 months
description: VA Corporate Data Warehouse refill data (Veteran participants)
measure: Change in medication adherence at 12 months
time frame: 12 months
description: Peoplechart Meds Incontext refill data (non-Veteran participants)
arm group label: Text Message Group
arm group type: Experimental
description: The "TM group" will use the VA "Annie" text messaging program to remind patients to take antiplatelet medications. The content for the text messages will be determined through preliminary focus groups that will be conducted prior to the RCT.
arm group label: Application Group
arm group type: Experimental
description: The "App group" will use a mobile application to remind patients to take antiplatelet medications. The commercially available mobile app will be selected by participants through preliminary focus groups that will be conducted prior to the RCT.
arm group label: Website-Control
arm group type: Experimental
description: The "Website-Control group" will will be offered the American Heart Association patient education website (My Life Check - 7 Steps To Healthy Living) and will serve as an "attention-control." The website will be offered to participants in all three groups. The "7 small steps to big changes" are to manage blood pressure, control cholesterol, reduce blood sugar, get active, eat better, lose weight, and stop smoking.
intervention type: Behavioral
intervention name: Text Message
description: Annie (VA text messaging program) or mobile Health manager (private text messaging program for non-VA female participants recruited at non-VA facility)
arm group label: Text Message Group
intervention type: Behavioral
intervention name: Mobile Application
arm group label: Application Group
intervention type: Other
intervention name: Website
description: American Heart Association patient education website
arm group label: Application Group
arm group label: Text Message Group
arm group label: Website-Control
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Linda Park, PhD
role: Principal Investigator
affiliation: San Francisco Veterans Medical Center; University of California, San Francisco
last name: Linda Park, PhD, MS, FNP
email: Linda.Park@ucsf.edu
last name: Julia von Oppenfeld
phone: 415-676-1153
email: Julia.vonOppenfeld@va.gov
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Linda Park
investigator title: Assistant Professor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
sharing ipd: Undecided