<?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>IRCT20200112046101N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-11</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-esteem training on improving cardiovascular outcomes in patients with cardio vascular diseases</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-esteem training on improving cardiovascular outcomes in patients with cardio vascular diseases.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45199</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Hypertension. Condition 2: coronary disease. Condition 3: Heart failure.</hc_freetext>
      <i_freetext>Intervention group: Patients will attend a two-and-a-half hour session per week for 2 months. During these sessions, patients will receive training of the mindfulness-based stress reduction protocol..</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:
after completion of the study, data on participants (unnamed) and the results of their analysis and the statistical methods wil be used in the study will be provided to other individuals along with the protocol.

When:
Access starte 1 month after the article was published

To whom:
Anyone can access the data

Conditions:
People can use the data for therapeutic and research purposes

Where to obtain:
e.kazemi@shmu.ac.ir Recipient: Erfan Kazemi
Contact  Phone Number of erfan kazemi: 00989155868605

How to obtain:
The researcher contact with the mentioned communication methods and then  person receive information via email Less than a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Erfan Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, 7 Tir Square, Shahrud</address>
        <city>Shahrud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773947</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>e.kazemi@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Erfan Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, 7 Tir Square, Shahrud</address>
        <city>Shahrud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773947</zip>
        <telephone>098 23 32395054</telephone>
        <email>e.kazemi@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A person with coronary artery disease (coronary syndrome or heart failure or hypertension) is certified by a specialist doctor and has been with the disease for at least 6 months.
The person consent to participate in the project</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have cognitive problems
Have other acute disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10-I15</hc_code>
      <hc_code>I25.1</hc_code>
      <hc_code>I24.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>فشار خون بالا (شریانی) (خوش خیم) (ضروری) (بدخیم) (اولیه) (سیستمیک)</hc_keyword>
      <hc_keyword>Coronary (artery):· atheroma· atherosclerosis· disease· sclerosis</hc_keyword>
      <hc_keyword>Coronary:· failure· insufficiency</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients will attend a two-and-a-half hour session per week for 2 months. During these sessions, patients will receive training of the mindfulness-based stress reduction protocol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-steem mean person's inner feeling to himself. Timepoint: Before the start of training and during all 4 courses follow up. Method of measurement: Rosenberg Self-esteem Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body mass index. Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: wieght/(length*length).</sec_outcome>
      <sec_outcome>Frequency of arrhythmia (supra ventricular, ventricular, transient and stable). Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: Electrocardiogram.</sec_outcome>
      <sec_outcome>Blood pressure (systolic, diastolic, mean). Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: sphygmomanometer.</sec_outcome>
      <sec_outcome>Ejection fraction. Timepoint: Before intervention, 3 months after education,  12 months after education. Method of measurement: (Stroke volume / end-diastolic volume of the heart) *100.</sec_outcome>
      <sec_outcome>The frequency of recurrence of acute coronary syndrome (re-infarction, unstable angina). Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: Electrocardiogram.</sec_outcome>
      <sec_outcome>Dosage of medication. Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: questinnaire.</sec_outcome>
      <sec_outcome>Number of medicines consumed. Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: questinnaire.</sec_outcome>
      <sec_outcome>Continuance use of medication. Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: questinnaire.</sec_outcome>
      <sec_outcome>Stress Tolerance. Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: Connor-Davidson  questinnaire.</sec_outcome>
      <sec_outcome>Number of readmissions due to cardiovascular disease (acute pulmonary edema, hypertension crisis). Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: questinnaire.</sec_outcome>
      <sec_outcome>The number of chest pain recurrence. Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: questinnaire.</sec_outcome>
      <sec_outcome>Functional Class. Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: questinnaire.</sec_outcome>
      <sec_outcome>Shortness of breath. Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: questinnaire.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education. Method of measurement: sf-36 questinnaire.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-12</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahrud, 7 Tir Squar, Shahroud University of Medical Sciences Shahrud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
