<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/NCT03244267</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00094970</org_study_id>
    <nct_id>NCT03244267</nct_id>
  </id_info>
  <brief_title>App Reminder on ASA Adherence</brief_title>
  <official_title>Impact of a Smartphone App Reminder on Adherence Aspirin Prescribed as Anti-Thrombotic Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Association of Orthopaedic Nurses</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</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 explore the impact of using a smartphone app reminder on&#xD;
      medication adherence twice daily in adults prescribed 81 milligrams of aspirin for 35 days as&#xD;
      anti-thrombotic therapy after knee or hip arthroplasty.&#xD;
&#xD;
      This study will randomly assign participants to get usual postoperative care which is&#xD;
      teaching with verbal instructions and printed information about taking the aspirin at the&#xD;
      time of discharge, or to have an app on your smartphone with preset reminders in addition to&#xD;
      usual postoperative discharge teaching after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the impact of using a smartphone application (app)&#xD;
      reminder on medication adherence twice daily in 200 adults prescribed 81 milligrams of&#xD;
      aspirin (ASA) for 35 days as anti-thrombotic therapy after knee or hip arthroplasty. The aim&#xD;
      is to determine if an app downloaded on a smartphone that reminds patients twice a day to&#xD;
      take their ASA as prescribed will improve ASA adherence and clinical outcomes for patients&#xD;
      after total knee and total hip joint arthroplasty compared to those in the usual care.&#xD;
&#xD;
      This is a two group, randomized control study with random assignment into the control group&#xD;
      for usual care or the intervention group to receive a medication reminder app for their smart&#xD;
      phone (daily for 35 days) plus usual care. Participants will receive a baseline interview for&#xD;
      demographic and other data and 36 day follow-up assessment, both conducted in person.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">March 8, 2019</completion_date>
  <primary_completion_date type="Actual">March 8, 2019</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>Proportion of Pills Taken</measure>
    <time_frame>Post- Operative Visit (Day 36)</time_frame>
    <description>The proportion of pills taken is defined as the percentage of pills taken by study participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score</measure>
    <time_frame>Post- Operative Visit (Day 36)</time_frame>
    <description>The ACTG Adherence Questionnaire consists of 19 items measuring different aspects of efficacy (or confidence) in the management of one's medication. Each item is rated from 0 (&quot;I cannot do at all&quot;) to 10 (&quot;Sure I can do&quot;), with total scores found by summing responses to individual items and dividing by 19. Higher scores correspond to higher levels of medication self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspirin (ASA) Self-Efficacy Scale Score</measure>
    <time_frame>Post- Operative Visit (Day 36)</time_frame>
    <description>The ASA Self-Efficacy Scale consists of 19 items measuring different aspects of efficacy (or confidence) in the management of one's medication. Each item is rated from 0 (&quot;I cannot do at all&quot;) to 10 (&quot;Sure I can do&quot;), with total scores found by summing responses to individual items and dividing by 19. Higher scores correspond to higher levels of medication self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Thromboembolic Events</measure>
    <time_frame>Post- Operative Visit (Day 36)</time_frame>
    <description>Clinical outcomes will be assessed at follow-up by self-report questions to ascertain if any thromboembolic events occurred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspirin (ASA) General Adherence Scale Score</measure>
    <time_frame>Post- Operative Visit (Day 36)</time_frame>
    <description>The ASA General Adherence Scale measures the ease and ability to adhere to the ASA regimen as prescribed. It is scored by summing responses to the individual items and creating a total score. Higher scores indicate better self-reported adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unified Theory of Acceptance and Use of Technology (UTAUT2) Survey Score</measure>
    <time_frame>Baseline (Pre-Intervention)</time_frame>
    <description>The UTAUT2 measures antecedents (performance expectancy, effort expectancy, hedonic motivation) and behavioral intent to use mobile apps. Items are scored using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Survey totals range between 14 and 112. Higher scores are indicative of greater acceptance and intent to adopt the target technology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance Expectancy Subscale Score</measure>
    <time_frame>Baseline (Pre-Intervention)</time_frame>
    <description>The Performance Expectancy Subscale measures the perceived benefits of mobile app technology to the consumer. Scores range from 4 to 28, with higher totals indicating better perceptions of technology-related benefits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effort Expectancy Subscale Score</measure>
    <time_frame>Baseline (Pre-Intervention)</time_frame>
    <description>The Effort Expectancy Subscale measures the ease with which the consumer can learn and operate an app. Scores range from 4 to 28, with higher totals indicating greater beliefs that the technology is easy and accessible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hedonic Motivation Subscale Score</measure>
    <time_frame>Baseline (Pre-Intervention)</time_frame>
    <description>The Hedonic Motivation subscale measures the enjoyment, the consumer experiences from using an app. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (Absolutely True) to 7 (Absolutely Untrue). Scoring is kept continuous with higher scores indicating greater enjoyment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Intent Subscale Score</measure>
    <time_frame>Baseline (Pre-Intervention)</time_frame>
    <description>The Behavioral Intent Subscale measures the decision to use a mobile app. Scores range from 3 to 21, with higher totals indicating a greater intent to use or adopt an app.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">195</enrollment>
  <condition>Thromboembolic Event</condition>
  <arm_group>
    <arm_group_label>Standard Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this arm will receive the standard education provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medication Reminder App + Standard Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will use a smartphone app with preset reminders to take aspirin to prevent thromboembolic events after orthopedic surgery in addition to usual postoperative discharge teaching.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Education</intervention_name>
    <description>Participants will receive the usual verbal education and printed information provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery, medication dosage and scheduling.</description>
    <arm_group_label>Medication Reminder App + Standard Education</arm_group_label>
    <arm_group_label>Standard Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Medication Reminder App</intervention_name>
    <description>Participants will use a medication reminder app that is set in collaboration with the participants for times that fit into their daily lifestyle. The app will alert participants when it is time (selected by the participant) to take their medication.</description>
    <arm_group_label>Medication Reminder App + Standard Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prescribed aspirin 81 mg twice a day for 35 days&#xD;
&#xD;
          -  Ability to write and speak English&#xD;
&#xD;
          -  Have a smart phone with the capacity to download and set an app&#xD;
&#xD;
          -  Own and use a smart phone for communication purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of mental illness&#xD;
&#xD;
          -  Do not own a smart phone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah Wittig-Wells, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory Orthopedic and Spine Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Deborah Wittig-Wells, RN, PhD</investigator_full_name>
    <investigator_title>Adjunct Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Orthopedics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</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/NCT03244267
org study id: IRB00094970
nct id: NCT03244267
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the impact of using a smartphone app reminder on
      medication adherence twice daily in adults prescribed 81 milligrams of aspirin for 35 days as
      anti-thrombotic therapy after knee or hip arthroplasty.

      This study will randomly assign participants to get usual postoperative care which is
      teaching with verbal instructions and printed information about taking the aspirin at the
      time of discharge, or to have an app on your smartphone with preset reminders in addition to
      usual postoperative discharge teaching after surgery.
The purpose of this study is to evaluate the impact of using a smartphone application (app)
      reminder on medication adherence twice daily in 200 adults prescribed 81 milligrams of
      aspirin (ASA) for 35 days as anti-thrombotic therapy after knee or hip arthroplasty. The aim
      is to determine if an app downloaded on a smartphone that reminds patients twice a day to
      take their ASA as prescribed will improve ASA adherence and clinical outcomes for patients
      after total knee and total hip joint arthroplasty compared to those in the usual care.

      This is a two group, randomized control study with random assignment into the control group
      for usual care or the intervention group to receive a medication reminder app for their smart
      phone (daily for 35 days) plus usual care. Participants will receive a baseline interview for
      demographic and other data and 36 day follow-up assessment, both conducted in person.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Proportion of Pills Taken
time frame: Post- Operative Visit (Day 36)
description: The proportion of pills taken is defined as the percentage of pills taken by study participants.
measure: AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score
time frame: Post- Operative Visit (Day 36)
description: The ACTG Adherence Questionnaire consists of 19 items measuring different aspects of efficacy (or confidence) in the management of one's medication. Each item is rated from 0 ("I cannot do at all") to 10 ("Sure I can do"), with total scores found by summing responses to individual items and dividing by 19. Higher scores correspond to higher levels of medication self-efficacy.
measure: Aspirin (ASA) Self-Efficacy Scale Score
time frame: Post- Operative Visit (Day 36)
description: The ASA Self-Efficacy Scale consists of 19 items measuring different aspects of efficacy (or confidence) in the management of one's medication. Each item is rated from 0 ("I cannot do at all") to 10 ("Sure I can do"), with total scores found by summing responses to individual items and dividing by 19. Higher scores correspond to higher levels of medication self-efficacy.
measure: Number of Thromboembolic Events
time frame: Post- Operative Visit (Day 36)
description: Clinical outcomes will be assessed at follow-up by self-report questions to ascertain if any thromboembolic events occurred.
measure: Aspirin (ASA) General Adherence Scale Score
time frame: Post- Operative Visit (Day 36)
description: The ASA General Adherence Scale measures the ease and ability to adhere to the ASA regimen as prescribed. It is scored by summing responses to the individual items and creating a total score. Higher scores indicate better self-reported adherence.
measure: Unified Theory of Acceptance and Use of Technology (UTAUT2) Survey Score
time frame: Baseline (Pre-Intervention)
description: The UTAUT2 measures antecedents (performance expectancy, effort expectancy, hedonic motivation) and behavioral intent to use mobile apps. Items are scored using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Survey totals range between 14 and 112. Higher scores are indicative of greater acceptance and intent to adopt the target technology.
measure: Performance Expectancy Subscale Score
time frame: Baseline (Pre-Intervention)
description: The Performance Expectancy Subscale measures the perceived benefits of mobile app technology to the consumer. Scores range from 4 to 28, with higher totals indicating better perceptions of technology-related benefits.
measure: Effort Expectancy Subscale Score
time frame: Baseline (Pre-Intervention)
description: The Effort Expectancy Subscale measures the ease with which the consumer can learn and operate an app. Scores range from 4 to 28, with higher totals indicating greater beliefs that the technology is easy and accessible.
measure: Hedonic Motivation Subscale Score
time frame: Baseline (Pre-Intervention)
description: The Hedonic Motivation subscale measures the enjoyment, the consumer experiences from using an app. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (Absolutely True) to 7 (Absolutely Untrue). Scoring is kept continuous with higher scores indicating greater enjoyment.
measure: Behavioral Intent Subscale Score
time frame: Baseline (Pre-Intervention)
description: The Behavioral Intent Subscale measures the decision to use a mobile app. Scores range from 3 to 21, with higher totals indicating a greater intent to use or adopt an app.
arm group label: Standard Education
arm group type: Active Comparator
description: Participants randomized to this arm will receive the standard education provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery.
arm group label: Medication Reminder App + Standard Education
arm group type: Experimental
description: Participants randomized to this arm will use a smartphone app with preset reminders to take aspirin to prevent thromboembolic events after orthopedic surgery in addition to usual postoperative discharge teaching.
intervention type: Behavioral
intervention name: Standard Education
description: Participants will receive the usual verbal education and printed information provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery, medication dosage and scheduling.
arm group label: Medication Reminder App + Standard Education
arm group label: Standard Education
intervention type: Behavioral
intervention name: Medication Reminder App
description: Participants will use a medication reminder app that is set in collaboration with the participants for times that fit into their daily lifestyle. The app will alert participants when it is time (selected by the participant) to take their medication.
arm group label: Medication Reminder App + Standard Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Deborah Wittig-Wells, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Deborah Wittig-Wells, RN, PhD
investigator title: Adjunct Associate Professor
mesh term: Thromboembolism
sharing ipd: Undecided