<?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>IRCT201504304443N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-01</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Scinces</primary_sponsor>
      <public_title>The effect of self-management program on ischemic heart disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-management program on therapeutic adherence and quality of life in patient with ischemic heart disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4757</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, patients with convenience sampling method (available) will be selected randomly (draw) and will be enrolled the study in both intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patient with ischemic heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In control group just will receive regular care at discharge include advice on medications and low salt and low-fat food, without any intervention. Intervention 2: Intervention group  : Beside receiving the usual care, the examination group will participate in self-management program which is hold with the partnership of 15 patients during sequential days, 4 hours each in the very first week after discharge. Workshops run by the researcher in the shape of educational lectures, discussions between patients and researchers, Exchange of experiences, correct the previous mistakes and finally answer the questions by researchers. The Workshop contains learning the nature of the disease, its complications, risk factors and methods of control, stress reduction techniques and methods to overcome the problems by scenario of problems and comments, share information and experiences of patients with the help of researchers, the participants will practice problem solving. The intervention focuses on increasing acceptance of medication regimen, nutrition, weight loss if needed, reducing sodium intake, regular physical activity, (walking) and quit smoking. After that for next 8 weeks, it follows-up verbal encouragement, questions and answers, improving teaching and managing disease once a week for about 10 minutes, according to research done by the patient needs. Phone calls between 8 am to 8 pm on the specified date and time will be agreed by the researcher and the research units. After the eight-week intervention for the patients for next four weeks, except very necessary will be provided by Phone call.</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>Masoumeh Zakerimoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 64359</telephone>
        <email>zakerimo@sina.tums.ac.ir</email>
        <affiliation>Nursing- Midwifery Faculty of Tehran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Zakeri Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 64359</telephone>
        <email>zakerimo@sina.com</email>
        <affiliation>Tehran University of Medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:(ability to read and write; aged between 30 and 65 years; ischemic heart disease that diagnosed by physicians; traverse at least one year of diagnosis of ischemic heart disease; The absence of non cardiac chronic underlying disease that affects quality of life; No previous Enterprises self management training&#13;
Exclusion criteria: The patient died during the study; The patient enters the acute phase; If the patient does not Enterprises in the telephone intervention)</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>151.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>125.0</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In control group just will receive regular care at discharge include advice on medications and low salt and low-fat food, without any intervention.</i_keyword>
      <i_keyword>Intervention group  : Beside receiving the usual care, the examination group will participate in self-management program which is hold with the partnership of 15 patients during sequential days, 4 hours each in the very first week after discharge. Workshops run by the researcher in the shape of educational lectures, discussions between patients and researchers, Exchange of experiences, correct the previous mistakes and finally answer the questions by researchers. The Workshop contains learning the nature of the disease, its complications, risk factors and methods of control, stress reduction techniques and methods to overcome the problems by scenario of problems and comments, share information and experiences of patients with the help of researchers, the participants will practice problem solving. The intervention focuses on increasing acceptance of medication regimen, nutrition, weight loss if needed, reducing sodium intake, regular physical activity, (walking) and quit smoking. After that for next 8 weeks, it follows-up verbal encouragement, questions and answers, improving teaching and managing disease once a week for about 10 minutes, according to research done by the patient needs. Phone calls between 8 am to 8 pm on the specified date and time will be agreed by the researcher and the research units. After the eight-week intervention for the patients for next four weeks, except very necessary will be provided by Phone call.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Therapeutic adherence. Timepoint: before and 12 weeks after intervention. Method of measurement: therapeutic adherence questionair in patient with ischemic heart disease.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: before and 12 weeks after intervention. Method of measurement: mac new quality of life questionair.</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, Tehran University of Medical Scinces</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical  Sciences</contact_name>
        <contact_address>Office building of Tehran University of medical  Sciences, Keshavarz St, Tehran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
