<?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>IRCT201104276314N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-06-13</date_registration>
      <primary_sponsor>Vice chancellor for research,Tehran University Medical Science</primary_sponsor>
      <public_title>Family_Center Empowerment Model and treatment regime adherence</public_title>
      <acronym></acronym>
      <scientific_title>Clinical Trial Effect of Family_Center Empowerment Model on adherence to treatment plan patients undergoing coronary artery bypass</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6762</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Ischemic Heart disease.</hc_freetext>
      <i_freetext>Intervention 1: In this study, for experimental group, Family_Center Empowerment Model on four dimensions of perceived threat, self-efficacy, educational participation and evaluation was performed. In the first step ( understanding threats ) about the disease, the need for treatment ( transplant coronary artery surgery ), prognosis, condition after the operation, care during surgery and after effects of treatment failure and a short program and fourth in the second session till about nutrition, drug activity, movement, stress, tobacco discussion were, stage II Problem solving or problem-solving method group took meetings solving method group in groups of four to six persons for patients was held and the purpose of this phase increased levels efficacy of patients had stage III or participation in the training phase subjects discussed at meetings by the active member of his family had the education, stage IV or stage of the evaluation at this stage after finishing the intervention group and control group experienced adherence questionnaire  Treatment plan and specific tools of empowerment was completed by subjects. Intervention 2: Intervention control group only received routine section. Routine part of the intervention order, health and educational measures is no difference for all patients whether or control group experienced was done.  In this study, the control group only received the care and the experimental group received the care and training classes on the steps of empowering family centered model was also used.  In fact, in the present study, a researcher for the control group did not do any intervention and control groups experienced similar educational programs and health sector by health care providers are doing for them was used.</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>Soraya Nejati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University School of Nursing and Midwifery, East Nosrat St, Forsat St, Tohid Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>nedasanaie@ymail.com</email>
        <affiliation>Tehran University Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soraya Nejati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University School of Nursing and Midwifery, East Nosrat St, Forsat St, Tohid Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>nedasanaie@ymail.com; nedasanaie@gmail.com</email>
        <affiliation>Tehran University Medacal Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion:&#13;
	Patient or his family, read and write have; patient or family can understand and have the speech in Farsi; patient undergoing emergency heart surgery is not received; client for the first time for coronary bypass surgery are hospitalized; mental illness  - mental health are not known; possibility of a direct telephone call home patients exist. &#13;
exclusion:&#13;
   Patients with cardiac problems due to reasons other than the current, or need for hospitalization and intervention is Avrzhrans so that the curriculum fails to comply; during the study or the patient's disease will progress to death; patient developed a new physical limitations that will prevent him from compliance  Exercise program should be.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20, I21, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischemic Heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, for experimental group, Family_Center Empowerment Model on four dimensions of perceived threat, self-efficacy, educational participation and evaluation was performed. In the first step ( understanding threats ) about the disease, the need for treatment ( transplant coronary artery surgery ), prognosis, condition after the operation, care during surgery and after effects of treatment failure and a short program and fourth in the second session till about nutrition, drug activity, movement, stress, tobacco discussion were, stage II Problem solving or problem-solving method group took meetings solving method group in groups of four to six persons for patients was held and the purpose of this phase increased levels efficacy of patients had stage III or participation in the training phase subjects discussed at meetings by the active member of his family had the education, stage IV or stage of the evaluation at this stage after finishing the intervention group and control group experienced adherence questionnaire  Treatment plan and specific tools of empowerment was completed by subjects.</i_keyword>
      <i_keyword>Intervention control group only received routine section. Routine part of the intervention order, health and educational measures is no difference for all patients whether or control group experienced was done.  In this study, the control group only received the care and the experimental group received the care and training classes on the steps of empowering family centered model was also used.  In fact, in the present study, a researcher for the control group did not do any intervention and control groups experienced similar educational programs and health sector by health care providers are doing for them was used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to treatment regimen. Timepoint: Before the intervention and 8 weeks after intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Empowerment. Timepoint: Before and one month after intervention. Method of measurement: Questionnaire.</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 Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Ethics committee ofTehran university medical science</contact_name>
        <contact_address>Sixth Floor, Central Building Education, Ghods Street, Keshavarz Blvd, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
