<?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>IRCT2016010425842N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-01</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Illness perception correction in patients with coronary artery disease</public_title>
      <acronym></acronym>
      <scientific_title>Effect of an educational intervention based on illness perception correction on control of some risk factors and incidence of acute coronary syndrome in patients with coronary artery disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21573</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Coronary artery disease. Condition 2: Acute coronary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: In control group no intervention was done.These patients just received routine care of the unit (routine nursing Care including carrying out doctors' orders, brief explanation on diet and medications at time of discharge). Intervention 2: In intervention group, an intervention on the basis of correcting the patient’s perception of the illness was carried out for three 30-40 minute sessions during hospitalization. The intervention was individually through the face-to-face conversation according to the response of each patient to the Illness Perception Questionnaire-Revised version. On discharge, the patients were supplied with an education booklet and CD. Then, the intervention group was followed up by telephone contacts for 20 to 30 minutes for three months after discharge. In this follow-up, the appropriate behaviors of the patients were encouraged, the benefits of adopting these behaviors were emphasized, and finally their questions were answered.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahin Roohani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan School of Nursing and Midwifery School, Haj Ahmad Mahdavi Sq, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3315 6918</telephone>
        <email>Roohani@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Roohani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan School of Nursing and Midwifery School, Haj Ahmad Mahdavi Sq, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3315 6918</telephone>
        <email>Roohani@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Being a candidate for angiography; Being older than 18 years; Not having  a history of acute coronary syndrome; Not having any mental disease; Not having any cognitive disorder; Not being a subject for any other study; Possibility of making a phone contact with the patient   Exclusion criteria: Not being diagnosed with coronary artery disease by angiography; Deterioration of the patient's medical condition before completing intervention; Discharge before completing the intervention; Reluctance to cooperate with the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
      <hc_code>I24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease</hc_keyword>
      <hc_keyword>Acute ischaemic heart disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In control group no intervention was done.These patients just received routine care of the unit (routine nursing Care including carrying out doctors' orders, brief explanation on diet and medications at time of discharge)</i_keyword>
      <i_keyword>In intervention group, an intervention on the basis of correcting the patient’s perception of the illness was carried out for three 30-40 minute sessions during hospitalization. The intervention was individually through the face-to-face conversation according to the response of each patient to the Illness Perception Questionnaire-Revised version. On discharge, the patients were supplied with an education booklet and CD. Then, the intervention group was followed up by telephone contacts for 20 to 30 minutes for three months after discharge. In this follow-up, the appropriate behaviors of the patients were encouraged, the benefits of adopting these behaviors were emphasized, and finally their questions were answered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Illness perception. Timepoint: Before intervention, six months after intervention. Method of measurement: Illness Perception Questionnaire-Revised.</prim_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: Before intervention, six months after intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before intervention, six months after intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: Before intervention, six months after intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before intervention, six months after intervention. Method of measurement: Aneroid sphygmomanometer.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before intervention, six months after intervention. Method of measurement: Aneroid sphygmomanometer.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: Before intervention, six months after intervention. Method of measurement: weight (kg) / [height (m)]2, kg/m2.</prim_outcome>
      <prim_outcome>Smoking. Timepoint: Before intervention, six months after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Incidence of acute coronary syndrome. Timepoint: Six months after intervention. Method of measurement: Patient's medical file and Diagnosis of the physician.</prim_outcome>
      <prim_outcome>Length. Timepoint: Before intervention. Method of measurement: Measuring tape.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before intervention, six months after intervention. Method of measurement: Scale.</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>Vice Chancellor for Research of Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-10</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences, Azadi Sq, Zanjan, Iran Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
