<?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>IRCT201201055499N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-02</date_registration>
      <primary_sponsor>The Office of the Vice chancellor for research, Guilan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of self-efficacy-based intervention on self-care level in diabetic adolescents</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of self-efficacy-based intervention on self-care level in diabetic  adolescents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-01-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5901</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>1</phase>
      <hc_freetext>Diabetes Mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Case group: After signing an informed consent, the participants filled out questionnaires specifically designed for these adolescents regarding demographic data, self-efficacy and self-care in relation to their diagnoses, in the presence of the researcher. Before the implementation of the desired intervention, the researcher  determined the mean score of self-efficacy and self-care. The participants in the experimental group received  intervention designed to enhance self-efficacy based on Bandura’s theory. The intervention involved  three sessions each week-each session lasting 2 hours-for the total duration of two weeks, in addition to the routine care. Intervention was directed at self-efficacy enhancement according to Bandura's theory. The intervention involved preparing the appropriate practice conditions, using other patients' successful experiences, and getting and building on feedback. In two episodes, immediately after the completion of the intervention and three months later, all participants  filled out the questionnaire again. Additionally, the researcher measured and recorded  glycosylated hemoglobin (HbA1c) before and after the intervention. Intervention 2: Control group: researcher did not any intervention in this group. Both groups received routine care.</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>Seyedeh Noshaz Mirhaghjou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Nursing and Midwifery College, Daneshjoo Boulevard, Shahid Beheshti Highway, Rasht, Guilan, The Islamic Republic of Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41469-39814</zip>
        <telephone>+98 13 1555 6046</telephone>
        <email>n_haghjou@gums.ac.ir</email>
        <affiliation>Shahid Beheshti Nursing and Midwifery College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Noshaz Mirhaghjou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Nursing and Midwifery College, Daneshjoo Boulevard, Shahid Beheshti Highway, Rasht, Guilan, The Islamic Republic of Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>39814-41469</zip>
        <telephone>+98 13 1555 6046</telephone>
        <email>n_haghjou@gums.ac.ir; n.haghjou@yahoo.com</email>
        <affiliation>Shahid Beheshti Nursing and Midwifery College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age between 11 and 20 ; being single; diabetic diagnosis at least for past two months. &#13;
Exclusion criteria: having hemoglobinopathy, anemia, reticulocytosis and uremia during study</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>20 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10, E 11,</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>E10 Insulin-dependent diabetes mellitus, E11 Non-insulin-dependent diabetes mellitus, E12 Malnutrition-related diabetes mellitus, E13 Other specified diabetes mellitus, E14 Unspecified diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Case group: After signing an informed consent, the participants filled out questionnaires specifically designed for these adolescents regarding demographic data, self-efficacy and self-care in relation to their diagnoses, in the presence of the researcher. Before the implementation of the desired intervention, the researcher  determined the mean score of self-efficacy and self-care. The participants in the experimental group received  intervention designed to enhance self-efficacy based on Bandura’s theory. The intervention involved  three sessions each week-each session lasting 2 hours-for the total duration of two weeks, in addition to the routine care. Intervention was directed at self-efficacy enhancement according to Bandura's theory. The intervention involved preparing the appropriate practice conditions, using other patients' successful experiences, and getting and building on feedback. In two episodes, immediately after the completion of the intervention and three months later, all participants  filled out the questionnaire again. Additionally, the researcher measured and recorded  glycosylated hemoglobin (HbA1c) before and after the intervention.</i_keyword>
      <i_keyword>Control group: researcher did not any intervention in this group. Both groups received routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care. Timepoint: Prior to the intervention,Immediately and after the intervention and after three months. Method of measurement: Diabetic adolescents self-care 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>The Office of the Vice chancellor for research, Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-11</approval_date>
        <contact_name>Ethics committee of vice chancellor for research , Guilan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research , Opposite of Alzahra hospital, Shahid Siadati street, Namjoo Avenue, Rasht  Rasht  Guilan  Iran, Islamic Republic Of  68164-41446 Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
