<?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>IRCT20230902059333N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-02</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of blended learning in cardiac rehabilitation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of blended learning in cardiac rehabilitation based on the model of knowledge, attitude, and performance on medication adherence and self-efficacy of patients undergoing coronary artery bypass graft surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72694</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, among the patients who have undergone coronary artery bypass surgery and meet the inclusion criteria, they were selected by the available sampling method and based on the random block method in the cardiac rehabilitation group based on the knowledge, attitude, and performance model (intervention) and the routine cardiac rehabilitation group (control). For this purpose,  the researcher will prepare 4 sheets, the number "1" will be written on two sheets for the first group, and the number "2" will be written on the two sheets for the second group. The cards are mixed in a container and randomly drawn one at a time for each patient without replacement until all four cards are drawn. Then four sheets are returned to the container, which is repeated until the sample volume is reached, Blinding description: A cardiac rehabilitation nurse will perform assessments at each stage, blinded to random allocation. Also, the statistical analysis and outcome assessment will not know about the assignment of patients to two intervention and control groups during the analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients undergoing coronary artery bypass surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After introducing the study and stating its objectives, if desired, the patients will complete the informed consent form, the demographic information form, the drug treatment adherence, and cardiac self-efficacy questionnaires. In addition to receiving routine cardiac rehabilitation provided at the hospital's cardiac rehabilitation center, this group of patients will receive the necessary training and care in the form of combined learning in both face-to-face and virtual departments. In the face-to-face department, patients will receive face-to-face training in various fields such as heart disease, diet, physical activity, and the benefits of cardiac rehabilitation for 1 month. In the virtual department, after completing the routine rehabilitation in the hospital, the patients will receive training and support for 3 months based on an application developed by the research team which will be installed on the phones of the patients or a family member who lives with them. This application will be designed based on the model of knowledge, attitude, and performance so that for each part of the model, a part will be seen in this application. Besides improving patients' knowledge in this way, they can communicate with the researcher and send their questions through it. At the same time as improves the knowledge of patients in the field of heart disease and cardiac rehabilitation and trying to change their attitude. The researcher changes their performance through this software by providing action plans, including sports activities, tailored to each person. The study's results will be examined through a questionnaire before the study, immediately after the completion of cardiac rehabilitation in the hospital, and 3 months later. Intervention 2: Control group: In this group, patients will enter the study after receiving informed consent and will complete the questionnaires. These people will only undergo routine cardiac rehabilitation in the hospital for one month (12 sessions, 3 times a week) and will not receive face-to-face and virtual training and care. At the end of the study, the training booklet will be given to this group. The study's results will be examined through a questionnaire before the study, immediately after the completion of cardiac rehabilitation in the hospital, and 3 months later.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is I must provide all information for the sponsoring institution.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gazal Veisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh Blvd., Pajouhesh Sq.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3838 0535</telephone>
        <email>ghazallv98@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Pakrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh Blvd., Pajouhesh Sq.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3838 0535</telephone>
        <email>f_pakrad@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Reading and writing literacy
Patients after coronary artery bypass graft
Desire to participate in the study
Performing coronary artery bypass graft surgery for the first time
Ejection fraction above 35%
Physical ability to perform exercise test
Access to a smartphone
Internet access</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Heart Failure class III and IV
Presence of severe musculoskeletal problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</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: After introducing the study and stating its objectives, if desired, the patients will complete the informed consent form, the demographic information form, the drug treatment adherence, and cardiac self-efficacy questionnaires. In addition to receiving routine cardiac rehabilitation provided at the hospital's cardiac rehabilitation center, this group of patients will receive the necessary training and care in the form of combined learning in both face-to-face and virtual departments. In the face-to-face department, patients will receive face-to-face training in various fields such as heart disease, diet, physical activity, and the benefits of cardiac rehabilitation for 1 month. In the virtual department, after completing the routine rehabilitation in the hospital, the patients will receive training and support for 3 months based on an application developed by the research team which will be installed on the phones of the patients or a family member who lives with them. This application will be designed based on the model of knowledge, attitude, and performance so that for each part of the model, a part will be seen in this application. Besides improving patients' knowledge in this way, they can communicate with the researcher and send their questions through it. At the same time as improves the knowledge of patients in the field of heart disease and cardiac rehabilitation and trying to change their attitude. The researcher changes their performance through this software by providing action plans, including sports activities, tailored to each person. The study's results will be examined through a questionnaire before the study, immediately after the completion of cardiac rehabilitation in the hospital, and 3 months later.</i_keyword>
      <i_keyword>Control group: In this group, patients will enter the study after receiving informed consent and will complete the questionnaires. These people will only undergo routine cardiac rehabilitation in the hospital for one month (12 sessions, 3 times a week) and will not receive face-to-face and virtual training and care. At the end of the study, the training booklet will be given to this group. The study's results will be examined through a questionnaire before the study, immediately after the completion of cardiac rehabilitation in the hospital, and 3 months later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy. Timepoint: Before, immediately after, and 3 months after the end of the intervention. Method of measurement: Using the cardiovascular disease management self-efficacy questionnaire of Steca et alii: The cardiovascular disease management self-efficacy questionnaire was designed and compiled by Steca et alii in 2015 to measure the self-efficacy of cardiovascular disease management. This questionnaire has 9 questions and 3 components of heart risk self-efficacy, treatment adherence self-efficacy, and symptom recognition self-efficacy. It is based on the Likert spectrum with questions such as (you can avoid life problems and difficult situations and daily stress well) Minimize stress well.). It measures the self-efficacy of cardiovascular disease management. The distribution of questionnaire questions is such that questions 1 to 4 examine the self-efficacy of heart risk, questions 5 and 6 examine the self-efficacy of following the treatment, and questions 7, 8, and 9 examine the self-efficacy of detecting symptoms.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Medication adherence. Timepoint: Before, immediately after, and 3 months after the end of the intervention. Method of measurement: Using the medication adherence reporting scale by Yan Chen et alii: The medication adherence reporting scale was compiled by Yan Chen et alii in 2019. This questionnaire contains 5 questions, and the frequency rating of each behavior in this questionnaire is based on a 5-point scale that is graded from never to always. The total score of the scale ranges from 5, which indicates the lowest level of adherence, to 25, which indicates the highest level of adherence.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-11</approval_date>
        <contact_name>Hamadan University of Medical Sciences</contact_name>
        <contact_address>Shahid Fahmideh Blvd., Pajouhesh Sq. Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
