<?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>IRCT20230722058876N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-11</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>Investigating the effect of educational intervention based on mobile phone application on self-care behaviors of patients after Coronary artery bypass surgery</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of educational intervention based on mobile phone application on self-care behaviors of patients after Coronary artery bypass surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71901</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: From the list of participants who meet the entry criteria and based on the determined sample size, the test and control groups will be selected randomly from among the participating patients. Sampling method will be available in this study in such a way that the patients referred for elective coronary artery bypass surgery in the open heart surgery center of Sanandaj city, who have the conditions to enter, will be included in the study and in order to make the research conditions uniform. For two intervention and control groups, it will be using sequential sampling method.</study_design>
      <phase>3</phase>
      <hc_freetext>Coronary Artery Bypass surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Self-care educational content in the form of a mobile application in different ways (videos, text, images) and in different formats (tests, Lightner reminder box, gamification, reminders, alarms, progress monitoring, control of vital signs) which includes medication reminders (recognition Medicine, side effects of each medicine, amount and time of taking each medicine), how to care for the wound, diet control, reminder of physical activity, amount of physical activity, use of gamification and reminder of when to visit the doctor, will be in the right hand of these patients. Intervention 2: Control group:  Patients referred to the heart surgery center who underwent elective surgery and need emergency surgery. If they want to participate in the study and meet the entry criteria, after providing explanations and receiving informed consent, they will be randomly placed in the control group and will receive the routine training of the department.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Part of the data (information about the main outcome and secondary outcomes) can be shared.

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
By citing the source, the use of documents is allowed.

Where to obtain:
Saeed Yarahmady, email: saeed.yarahmady@gmail.com, contact number 09188789172

How to obtain:
Sending an email or calling the researcher's phone number and fully explaining the process through which the information of this research is going to be used.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Yarahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Jalal AleAhmad Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33114115</zip>
        <telephone>+98 21 8288 4547</telephone>
        <email>saeed.yarahmadi@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Yarahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Jalal AleAhmad Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>333114115</zip>
        <telephone>+98 21 8288 4547</telephone>
        <email>saeed.yarahmadi@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness and ability to continue participating in research
Having a smartphone and the ability to install software and use it
Living in Sanandaj city within 6 months from the time of entering the study
Coronary artery bypass surgery and discharge from the hospital
Ability to provide informed consent</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participant suffering from a specific disease that makes it impossible for her to participate in the research
Patients undergoing emergency surgery
Patients who have neurological or cognitive impairments such as vision, hearing or cognitive impairment that impair their ability to use a digital device.
Receive training before entering the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z95.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of aortocoronary bypass graft</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Self-care educational content in the form of a mobile application in different ways (videos, text, images) and in different formats (tests, Lightner reminder box, gamification, reminders, alarms, progress monitoring, control of vital signs) which includes medication reminders (recognition Medicine, side effects of each medicine, amount and time of taking each medicine), how to care for the wound, diet control, reminder of physical activity, amount of physical activity, use of gamification and reminder of when to visit the doctor, will be in the right hand of these patients.</i_keyword>
      <i_keyword>Control group:  Patients referred to the heart surgery center who underwent elective surgery and need emergency surgery. If they want to participate in the study and meet the entry criteria, after providing explanations and receiving informed consent, they will be randomly placed in the control group and will receive the routine training of the department.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care behaviors after coronary artery bypass graft surgery. Timepoint: Before discharge, 1 and 3 months after surgery. Method of measurement: Questionnaire of knowledge, attitude and application of self-care in patients undergoing coronary artery bypass surgery.</prim_outcome>
      <prim_outcome>Knowledge of self-care behaviors after coronary artery bypass graft surgery. Timepoint: Before discharge, 1 and 3 months after surgery. Method of measurement: Questionnaire of knowledge, attitude and application of self-care in patients undergoing coronary artery bypass surgery.</prim_outcome>
      <prim_outcome>Attitudes towards self-care behaviors after coronary artery bypass surgery. Timepoint: Before discharge, 1 and 3 months after surgery. Method of measurement: Questionnaire of knowledge, attitude and application of self-care in patients undergoing coronary artery bypass surgery.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rehospitalization due to heart disease. Timepoint: After discharge, one and three months after surgery. Method of measurement: Number of hospital readmissions due to heart disease.</sec_outcome>
      <sec_outcome>Mortality due to heart disease. Timepoint: One year after surgery. Method of measurement: Death rate from heart disease.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Sanandaj University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tarbiat Modares University</source_name>
      <source_name>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-25</approval_date>
        <contact_name>Research Ethics Committees of Tarbit Modares University</contact_name>
        <contact_address>Faculty of Medicine, Tarbiat Modares University, Jalal Al-Ahmad St., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
