<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/NCT03766789</url>
  </required_header>
  <id_info>
    <org_study_id>A0001</org_study_id>
    <nct_id>NCT03766789</nct_id>
  </id_info>
  <brief_title>Use of a Smartphone Application to Increase Adherence to Medical Treatment in Patients With an Acute Coronary Syndrome.</brief_title>
  <acronym>ADHERENCE</acronym>
  <official_title>Use of a Smartphone Digital Application as a Tool to Increase Adherence to Medical Treatment in Patients Who Underwent Hospitalization for Acute Coronary Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Cardiovascular de Buenos Aires</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Cardiovascular de Buenos Aires</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>
      ADHERENCE is a randomized unicentric study that will be carried out from a monovalent center&#xD;
      of cardiology of the Autonomous City of Buenos Aires. Patients will be randomized&#xD;
      hospitalization for acute coronary syndromes (ACS) with and without ST segment elevation at&#xD;
      the time of hospital discharge to receive access to a digital application for smartphones or&#xD;
      receive written instructions regarding the taking of medication as prescribed by doctors .&#xD;
      They will have a total follow-up period of 90 days, in which the adherence to medical&#xD;
      treatment will be evaluated through a questionnaire validated for that purpose.&#xD;
&#xD;
      The objective of the study is to demonstrate that the use of a digital platform for&#xD;
      smartphones increases the adherence to medical treatment by 30% in relation to the group&#xD;
      without intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The World Health Organization (WHO) states that poor adherence to long-term medical&#xD;
      treatments severely compromises their effectiveness, with an expected adherence of 50% in&#xD;
      developed countries and less in developing countries. This non-compliance to medical&#xD;
      treatment tends to increase as the global burden of chronic diseases increases, where not&#xD;
      only the rational use of medicines but also compliance with prescribed treatments becomes&#xD;
      vitally important. So it is of interest to highlight the importance not only of the clarity&#xD;
      of the medical prescription at the time of hospital discharge but of compliance with it in&#xD;
      the out-of-hospital setting.&#xD;
&#xD;
      The lack of adherence to medical treatment is a difficult problem to solve, and this could&#xD;
      partially explain the ineffectiveness of the treatments administered by the health system.&#xD;
      Adherence is greater in the acute phase of the disease2, presenting a marked decrease within&#xD;
      3 to 6 months of treatment3. In order to avoid this problem, multiple interventions have been&#xD;
      studied without evidence of significant benefits or clinical impact.&#xD;
&#xD;
      The &quot;Medication Reminder&quot; application will be used as a digital tool for smartphones, which&#xD;
      is available for different commercial software platforms, free download. The intervention&#xD;
      group will have the installation of the aforementioned platform on your smartphone, loading&#xD;
      the list of your medication, as well as an alarm in the hours proposed for the shot. When the&#xD;
      warning is presented, the patient will have a warning by which he will have to accept or&#xD;
      reject the taking of the medication; to reject it, the reminder will remain present for 24hs&#xD;
      and then it will be automatically deleted. At the end of the day, the patient can access an&#xD;
      analysis of daily compliance and thus perform a self-monitoring. The control group will&#xD;
      receive the standard of care, consisted of a written list of medications.&#xD;
&#xD;
      We will evaluate the adherence to medications at 3 months as primary endpoint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 12, 2018</start_date>
  <completion_date type="Anticipated">January 27, 2019</completion_date>
  <primary_completion_date type="Actual">November 27, 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to treatment</measure>
    <time_frame>3 months</time_frame>
    <description>Rate of patients in each arm with adherence to medical treatment defined by the Morisky Green scale.&#xD;
The eight-item Morisky Medication Adherence Scale (MMAS-8) is a structured self-report measure of medication-taking behavior that has been widely used in various cultures. The first seven items are dichotomous response categories with yes or no and the last item was a five point Likert response. The adherence to medications is higher in patients with higher scale values (values from 0 to 8). A patient is consider to have good adherence when score is perfect (8 points)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact in clinical events</measure>
    <time_frame>3 months</time_frame>
    <description>Rate of patients in each arm with the combined event of re-hospitalizations for acute coronary syndromes, consultations to the medical emergency system or not planned visits to clinic.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Adherence, Medication</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>They will receive the cell phone application, as reminder of medications time and dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive standard of care recommendations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cell phone application</intervention_name>
    <description>cell phone to organize medications</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age.&#xD;
&#xD;
          -  Acquire hospitalization for acute coronary syndromes (ACS) with and without ST segment&#xD;
             elevation.&#xD;
&#xD;
          -  Have access to a smartphone in order to access the digital application provided.&#xD;
&#xD;
          -  Have the possibility to follow up after 90 days.&#xD;
&#xD;
          -  Sign the informed consent administered in writing prior to inclusion in the clinical&#xD;
             trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with coronary lesions with a revascularization planned (revascularization in&#xD;
             stages).&#xD;
&#xD;
          -  Severe limitation of mobility (amputation, degenerative myopathies, musculoskeletal&#xD;
             disorders).&#xD;
&#xD;
          -  Total or intermediate dependency for carrying out tasks of daily life according to the&#xD;
             validated Katz questionnaire of Activities of Daily Life (ADL). -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan P Costabel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chief of coronary care unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Juan Pablo Costabel</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1428</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Cardiovascular de Buenos Aires</investigator_affiliation>
    <investigator_full_name>Juan Pablo Costabel</investigator_full_name>
    <investigator_title>Principal Investigator.</investigator_title>
  </responsible_party>
  <keyword>Adherence, Medication, Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</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/NCT03766789
org study id: A0001
nct id: NCT03766789
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
ADHERENCE is a randomized unicentric study that will be carried out from a monovalent center
      of cardiology of the Autonomous City of Buenos Aires. Patients will be randomized
      hospitalization for acute coronary syndromes (ACS) with and without ST segment elevation at
      the time of hospital discharge to receive access to a digital application for smartphones or
      receive written instructions regarding the taking of medication as prescribed by doctors .
      They will have a total follow-up period of 90 days, in which the adherence to medical
      treatment will be evaluated through a questionnaire validated for that purpose.

      The objective of the study is to demonstrate that the use of a digital platform for
      smartphones increases the adherence to medical treatment by 30% in relation to the group
      without intervention
The World Health Organization (WHO) states that poor adherence to long-term medical
      treatments severely compromises their effectiveness, with an expected adherence of 50% in
      developed countries and less in developing countries. This non-compliance to medical
      treatment tends to increase as the global burden of chronic diseases increases, where not
      only the rational use of medicines but also compliance with prescribed treatments becomes
      vitally important. So it is of interest to highlight the importance not only of the clarity
      of the medical prescription at the time of hospital discharge but of compliance with it in
      the out-of-hospital setting.

      The lack of adherence to medical treatment is a difficult problem to solve, and this could
      partially explain the ineffectiveness of the treatments administered by the health system.
      Adherence is greater in the acute phase of the disease2, presenting a marked decrease within
      3 to 6 months of treatment3. In order to avoid this problem, multiple interventions have been
      studied without evidence of significant benefits or clinical impact.

      The "Medication Reminder" application will be used as a digital tool for smartphones, which
      is available for different commercial software platforms, free download. The intervention
      group will have the installation of the aforementioned platform on your smartphone, loading
      the list of your medication, as well as an alarm in the hours proposed for the shot. When the
      warning is presented, the patient will have a warning by which he will have to accept or
      reject the taking of the medication; to reject it, the reminder will remain present for 24hs
      and then it will be automatically deleted. At the end of the day, the patient can access an
      analysis of daily compliance and thus perform a self-monitoring. The control group will
      receive the standard of care, consisted of a written list of medications.

      We will evaluate the adherence to medications at 3 months as primary endpoint.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Adherence to treatment
time frame: 3 months
description: Rate of patients in each arm with adherence to medical treatment defined by the Morisky Green scale.
The eight-item Morisky Medication Adherence Scale (MMAS-8) is a structured self-report measure of medication-taking behavior that has been widely used in various cultures. The first seven items are dichotomous response categories with yes or no and the last item was a five point Likert response. The adherence to medications is higher in patients with higher scale values (values from 0 to 8). A patient is consider to have good adherence when score is perfect (8 points)
measure: Impact in clinical events
time frame: 3 months
description: Rate of patients in each arm with the combined event of re-hospitalizations for acute coronary syndromes, consultations to the medical emergency system or not planned visits to clinic.
arm group label: Intervention
arm group type: Active Comparator
description: They will receive the cell phone application, as reminder of medications time and dose.
arm group label: Control
arm group type: No Intervention
description: Patients will receive standard of care recommendations.
intervention type: Device
intervention name: Cell phone application
description: cell phone to organize medications
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Juan P Costabel, MD
role: Principal Investigator
affiliation: Chief of coronary care unit
facility: 
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Instituto Cardiovascular de Buenos Aires
investigator full name: Juan Pablo Costabel
investigator title: Principal Investigator.
mesh term: Acute Coronary Syndrome