<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/NCT03268291</url>
  </required_header>
  <id_info>
    <org_study_id>Call of Trust</org_study_id>
    <nct_id>NCT03268291</nct_id>
  </id_info>
  <brief_title>Communicational Program &quot;Trust&quot; to Improve Adherence to Medications</brief_title>
  <official_title>Impact of Communicational Program &quot;Trust&quot; on Adherence to Medications in Patients With Prior Myocardial Infarction Who Underwent Successful Revascularization by Stenting or Thrombolysis: A Prospective Multicenter Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meshalkin Research Institute of Pathology of Circulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meshalkin Research Institute of Pathology of Circulation</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 trial was designed in such a way as to show that the proposed program &quot;Trust&quot; increases&#xD;
      the proportion of patients who adhere to therapy in the cohort of those with coronary heart&#xD;
      disease for two years after successful revascularization by using thrombolytic or stenting of&#xD;
      the coronary arteries against the background of myocardial infarction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The &quot;Trust&quot; program includes a set of measures aimed at increasing the level of adherence to&#xD;
      therapy in patients with myocardial infarction. Differences in adherence rates between&#xD;
      patients enrolled in the program and patients undergoing standard outpatient care will be&#xD;
      monitored during the study. The study will be conducted according to the clinical approbation&#xD;
      protocol, the principles of good clinical practice (GCP) and regulatory requirements.&#xD;
&#xD;
      The developed program is based on the experience of international research studies and&#xD;
      includes the following sections:&#xD;
&#xD;
        -  daily seminars with patients going to be discharged about the benefits of adherence to&#xD;
           therapy; distribution of printed materials;&#xD;
&#xD;
        -  service for the regular informing of the patients which is motivating to remain&#xD;
           adherence to medications by automated contact management systems (SMS, e-mail), as well&#xD;
           as calls from contact center operators;&#xD;
&#xD;
        -  questioning of participants of the program for general adherence to therapy, reasons for&#xD;
           refusal, change of therapy / drug, complaints and other. The questioning is carried out&#xD;
           through telephone interviewing by contact center operators and automatic collection of&#xD;
           electronic forms through aggregator services.&#xD;
&#xD;
      Information motivating to remain adherence to the therapy is structured as follows:&#xD;
&#xD;
      A) greeting and presentation, a reminder of the necessity for therapy, with the support of&#xD;
      the patient's Trust in prolonging the quality of life by regular use of medications; B) the&#xD;
      explanation of the action of the medicine taking into account the peculiarities of ordinary&#xD;
      consciousness, warning the patient of the most common mistakes in treatment; C)&#xD;
      recommendations for changing lifestyle and explaining their need; D) a reminder of the&#xD;
      possibility to contact the attending physician, emotional support and counseling.&#xD;
&#xD;
      The establishment of an information and counseling center will allow the patient to be&#xD;
      supported throughout the time when the likelihood of giving up therapy and the risk of&#xD;
      complications due to failure are most likely.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 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>
    <intervention_model_description>The study will include 2,000 patients. Patients will be randomized into two groups: standard outpatient observation (n = 1 000), the &quot;Trust&quot; program (n = 1 000).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medication Adherence</measure>
    <time_frame>During 1 year</time_frame>
    <description>Adherence to every class of prescribed medications: Acetylsalicylic acid, P2Y12 receptor inhibitors, Beta-blockers, ACE inhibitors according to percent of medication taking days. Adherence above 80% will be satisfactory</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Standard outpatient observation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Outpatient management according to Ministry of health standards</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Communicational program &quot;Trust&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The developed program is based on the experience of international research studies and includes the following sections:&#xD;
daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials;&#xD;
service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators;&#xD;
questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard outpatient observation</intervention_name>
    <description>Outpatient management according to Ministry of health standards</description>
    <arm_group_label>Standard outpatient observation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Communicational program &quot;Trust&quot;</intervention_name>
    <description>The developed program is based on the experience of international research studies and includes the following sections:&#xD;
daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials; service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators; questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services.</description>
    <arm_group_label>Communicational program &quot;Trust&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Recent acute myocardial infarction within the past 2 months&#xD;
&#xD;
          -  Successful revascularization via coronary stenting or thrombolysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant cardiovascular disorders requiring surgical treatment&#xD;
&#xD;
          -  Coronary revascularization via CABG&#xD;
&#xD;
          -  Patient refused from participating&#xD;
&#xD;
          -  Patient is not available for communication within 2 months&#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_contact>
    <last_name>Aleksei Prokhorikhin</last_name>
    <phone>9137178040</phone>
    <email>turbogold@list.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>State Research Institute of CIrculation Pathology</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evgeny Kretov, MD, PhD</last_name>
      <email>sibvolna2005@yandex.ru</email>
    </contact>
    <investigator>
      <last_name>Evgeny Kretov, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aleksei Prokhorikhin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adherence to therapy</keyword>
  <keyword>Myocardial Infarction</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Communicational program</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All the data</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT03268291
org study id: Call of Trust
nct id: NCT03268291
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The trial was designed in such a way as to show that the proposed program "Trust" increases
      the proportion of patients who adhere to therapy in the cohort of those with coronary heart
      disease for two years after successful revascularization by using thrombolytic or stenting of
      the coronary arteries against the background of myocardial infarction.
The "Trust" program includes a set of measures aimed at increasing the level of adherence to
      therapy in patients with myocardial infarction. Differences in adherence rates between
      patients enrolled in the program and patients undergoing standard outpatient care will be
      monitored during the study. The study will be conducted according to the clinical approbation
      protocol, the principles of good clinical practice (GCP) and regulatory requirements.

      The developed program is based on the experience of international research studies and
      includes the following sections:

        -  daily seminars with patients going to be discharged about the benefits of adherence to
           therapy; distribution of printed materials;

        -  service for the regular informing of the patients which is motivating to remain
           adherence to medications by automated contact management systems (SMS, e-mail), as well
           as calls from contact center operators;

        -  questioning of participants of the program for general adherence to therapy, reasons for
           refusal, change of therapy / drug, complaints and other. The questioning is carried out
           through telephone interviewing by contact center operators and automatic collection of
           electronic forms through aggregator services.

      Information motivating to remain adherence to the therapy is structured as follows:

      A) greeting and presentation, a reminder of the necessity for therapy, with the support of
      the patient's Trust in prolonging the quality of life by regular use of medications; B) the
      explanation of the action of the medicine taking into account the peculiarities of ordinary
      consciousness, warning the patient of the most common mistakes in treatment; C)
      recommendations for changing lifestyle and explaining their need; D) a reminder of the
      possibility to contact the attending physician, emotional support and counseling.

      The establishment of an information and counseling center will allow the patient to be
      supported throughout the time when the likelihood of giving up therapy and the risk of
      complications due to failure are most likely.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study will include 2,000 patients. Patients will be randomized into two groups: standard outpatient observation (n = 1 000), the "Trust" program (n = 1 000).
primary purpose: Health Services Research
masking: None (Open Label)
measure: Medication Adherence
time frame: During 1 year
description: Adherence to every class of prescribed medications: Acetylsalicylic acid, P2Y12 receptor inhibitors, Beta-blockers, ACE inhibitors according to percent of medication taking days. Adherence above 80% will be satisfactory
arm group label: Standard outpatient observation
arm group type: Active Comparator
description: Outpatient management according to Ministry of health standards
arm group label: Communicational program "Trust"
arm group type: Experimental
description: The developed program is based on the experience of international research studies and includes the following sections:
daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials;
service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators;
questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services.
intervention type: Other
intervention name: Standard outpatient observation
description: Outpatient management according to Ministry of health standards
arm group label: Standard outpatient observation
intervention type: Behavioral
intervention name: Communicational program "Trust"
description: The developed program is based on the experience of international research studies and includes the following sections:
daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials; service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators; questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services.
arm group label: Communicational program "Trust"
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aleksei Prokhorikhin
phone: 9137178040
email: turbogold@list.ru
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: Yes
ipd description: All the data
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)