<?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>IRCT20250121064471N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-19</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of tailored web-based education on self-care behaviors and quality of life of patients with acute coronary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of tailored web-based education on self-care behaviors and quality of life of patients with acute coronary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81477</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: The allocation of samples to groups is done using the block random method. In order to equalize the distribution of confounding variables such as gender and age, first, classes are created based on these variables as follows: female/male and age ≥50/&lt;50 years. Then, using the block random method and using the block rand package of R software, a random sequence of random blocks will be formed as a sequence of letters A and B, and the samples will be placed in the study groups in a balanced manner.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute coronary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: McNew's quality of life and Miller's self-care questionnaires will be completed in paper form before the intervention begins. First, a patient-centered needs assessment will be conducted before the start of patient education. Then, the educational content tailored based on the needs assessment will be designed on a website, uploaded, and its URL link will be provided to the patients in the intervention group during their hospitalization in the CCU. In addition, patients will receive routine education during hospitalization and discharge orally by a nurse and physician. Patients will receive web-based education from the time of hospitalization until two months after discharge. After receiving the content, the questionnaires will be completed again by patients with acute coronary syndrome in the CCU during discharge and two months after discharge, in coordination with the patients, to the hospital in person to complete the questionnaires. Intervention 2: Control group: The McNew Quality of Life and Miller Self-Care Questionnaires will be completed in paper form by patients upon admission. Then, patients will receive routine education during hospitalization and discharge orally by nurses and physicians, and the questionnaires will be completed again by patients with acute coronary syndrome, upon discharge from the CCU, and two months after discharge, in coordination with the patients, to complete the questionnaires in person at the hospital.</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 There is no further information. A decision will be made in this regard later.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahereh Tolabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lorestan University of Medical Sciences and Health Services, Anooshirvan Rezaei Square, Khorramabad, Lorestan, Iran.</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813833946</zip>
        <telephone>+98 66 3330 2033</telephone>
        <email>mahhajimirza@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Tolabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lorestan University of Medical Sciences and Health Services, Anooshirvan Rezaei Square, Khorramabad, Lorestan, Iran.</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813833946</zip>
        <telephone>+98 66 3330 2033</telephone>
        <email>mahhajimirza@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Written consent to participate in the study should be obtained from patients before entering the study.
Patients diagnosed with acute coronary syndrome (stable and unstable angina, heart attack with/without ECG changes) are admitted to the intensive care unit.
Patients must have the necessary physical and cognitive abilities to participate in the research.
Patients should have the ability to use smartphones and social networks.
Patients must have access to home internet or a mobile phone.
The patient or caregiver must be literate.
Patients are between 30 and 70 years old.
Patients should not have hearing or speech problems.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute ischemic heart disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: McNew's quality of life and Miller's self-care questionnaires will be completed in paper form before the intervention begins. First, a patient-centered needs assessment will be conducted before the start of patient education. Then, the educational content tailored based on the needs assessment will be designed on a website, uploaded, and its URL link will be provided to the patients in the intervention group during their hospitalization in the CCU. In addition, patients will receive routine education during hospitalization and discharge orally by a nurse and physician. Patients will receive web-based education from the time of hospitalization until two months after discharge. After receiving the content, the questionnaires will be completed again by patients with acute coronary syndrome in the CCU during discharge and two months after discharge, in coordination with the patients, to the hospital in person to complete the questionnaires.</i_keyword>
      <i_keyword>Control group: The McNew Quality of Life and Miller Self-Care Questionnaires will be completed in paper form by patients upon admission. Then, patients will receive routine education during hospitalization and discharge orally by nurses and physicians, and the questionnaires will be completed again by patients with acute coronary syndrome, upon discharge from the CCU, and two months after discharge, in coordination with the patients, to complete the questionnaires in person at the hospital.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improving quality of life in patients with acute coronary syndrome. Timepoint: At the beginning of the study, during discharge, and two months after discharge. Method of measurement: McNew Quality of Life Questionnaire for Patients with Myocardial Infarction.</prim_outcome>
      <prim_outcome>Self-care behaviors in patients with acute coronary syndrome. Timepoint: At the beginning of the study, during discharge, and two months after discharge. Method of measurement: Miller Self-Care Behaviors Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-09</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Lorestan University of Medical Sciences and Health Services, Anooshirvan Rezaei Square. Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
