<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20111203008286N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Training patients with open heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effects of Gamification and Teach Back Training Methods on Treatment Regimen Adherence of Patients after Coronary Artery Bypass Graft Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>123</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41507</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Samples will be divided to 3 groups with block randomization.There are 9 possible ways to equally assign participants to block. Allocation proceeds by randomly selection by randomization.com  after that will be recognized treatment assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Treatment Regimen Adherence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before starting the test, the patient will complete informed consent form, demographic information questionnaire, dietary and movement regimen adherence questionnaire by Sanaie and colleagues, and Morisky Medication Adherence Scale. Then, the patient and the main caregiver in teach back group receive simple and understandable instructions without medical terminology. At the end of each training section, the patient is asked to express what he or she has understood. For example, training for physical activity is as follows: (most of patients after surgery can walk for 3 to 10 minutes continuously without intolerance. Please focus on time, not speed. Choose smooth paths. Hills make you exhausted). After the training, information given to patients will be assessed. About the above subject, the patient will be told that if he wants to train one of his relatives, what will he state? After the explanations of the patient, if there is misunderstanding, the content will be revised and the patient and the main caregiver are asked to restate the content and this process continues until the patient has a correct understanding. But if the patient or the main caregiver did not understand the points, other sessions are taken into consideration.  In the end, the presented information will be given to the patient in a form of a notebook to use it when needed. Thirty days after training, the questionnaire is completed again. Intervention 2: Intervention group 2: For the patient and the main caregiver in the gamification group, the informed consent form and medication regimen adherence scale were completed and then, the training application is installed on the cellphone of the patient or the main caregiver after discharge and the methods to use the game will be explained by the researcher. After educational motions and its games, the android programming prepares all games and graphics for the user as an android application. The final application includes 3 sections of 5 to 10 minutes of animation about physical activity, medication regimen, dietary regimen, and game. Thirty days after intervention, the questionnaire is completed again. For the control group (recipient of regular care), before intervention, dietary regimen adherence questionnaire and demographic information scale will be completed and after 30 days, medication regimen adherence questionnaire is completed again. Intervention 3: Control group: For the control group (receiving routine care), pre-intervention, demographic and adherence treatment questionnaires were completed and the questionnaires were completed again 30 days later. In this group, the patient doesn't receive any intervention.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Bahramnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Dr. Mirkhani St. (East Nosrat)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>bahramnezhad.f@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Bahramnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Dr. Mirkhani St. (East Nosrat)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>bahramnezhad.f@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with 18 and 60 years old
Having an Android phone cell by a patient or  main caregiver
ability to speaking and understanding Farsi
Willingness to participate in the study
no hearing and speech impairment</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients' unwillingness to continue research in any part of the study
The patient died</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.701</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris with documented spasm</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before starting the test, the patient will complete informed consent form, demographic information questionnaire, dietary and movement regimen adherence questionnaire by Sanaie and colleagues, and Morisky Medication Adherence Scale. Then, the patient and the main caregiver in teach back group receive simple and understandable instructions without medical terminology. At the end of each training section, the patient is asked to express what he or she has understood. For example, training for physical activity is as follows: (most of patients after surgery can walk for 3 to 10 minutes continuously without intolerance. Please focus on time, not speed. Choose smooth paths. Hills make you exhausted). After the training, information given to patients will be assessed. About the above subject, the patient will be told that if he wants to train one of his relatives, what will he state? After the explanations of the patient, if there is misunderstanding, the content will be revised and the patient and the main caregiver are asked to restate the content and this process continues until the patient has a correct understanding. But if the patient or the main caregiver did not understand the points, other sessions are taken into consideration.  In the end, the presented information will be given to the patient in a form of a notebook to use it when needed. Thirty days after training, the questionnaire is completed again.</i_keyword>
      <i_keyword>Intervention group 2: For the patient and the main caregiver in the gamification group, the informed consent form and medication regimen adherence scale were completed and then, the training application is installed on the cellphone of the patient or the main caregiver after discharge and the methods to use the game will be explained by the researcher. After educational motions and its games, the android programming prepares all games and graphics for the user as an android application. The final application includes 3 sections of 5 to 10 minutes of animation about physical activity, medication regimen, dietary regimen, and game. Thirty days after intervention, the questionnaire is completed again. For the control group (recipient of regular care), before intervention, dietary regimen adherence questionnaire and demographic information scale will be completed and after 30 days, medication regimen adherence questionnaire is completed again</i_keyword>
      <i_keyword>Control group: For the control group (receiving routine care), pre-intervention, demographic and adherence treatment questionnaires were completed and the questionnaires were completed again 30 days later. In this group, the patient doesn't receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Regimen adherence questionnaire score. Timepoint: Before  and  one month after the intervention. Method of measurement: Adherence to treatment regimen.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: 2 months after intervention. Method of measurement: quality of life questioner.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-08</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Tohid Sq. Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
