<?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>IRCT201407211788N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-06-01</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of family centered empowerment program on self-efficacy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of family- centered empowerment program on self-efficacy in adolescents  with thalassemia major</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1368</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Beta Thalassemia.</hc_freetext>
      <i_freetext>Intervention 1: Control group: these people are selected from specific diseases  Aboureihan center in Bandar Abbas. We give them the tools to complete their And 1.5 months later, without any intervention so that only routine nursing care received, the tools will be completed. Intervention 2: Intervention Group: Sampling available. these people are selected from specific diseases  Aboureihan center in Bandar Abbas. After obtaining the written consent of the subjects in the experimental group, pre-test will be conducted. Empowering patients based on four constructs: knowledge, self-efficacy, training participation and evaluation. The first step (perceived threat) empowerment program will try to increase their knowledge through booklets and group discussion. Thus, based on the number of teenagers, they were divided into groups of 3-5 people. Empowerment programs to suit the needs of the participants every two weeks, three sessions, 30-45 minutes. At this stage, Participants were asked to transfer educational materials that have learned to bring a family member. Therefore, educational pamphlets given to them To be an active member of family.  That study and questions that come to mind, write in a sheet and the next meeting, deliver researcher. Therefore, the next meeting will review all comments. . During the second step (self-efficacy), aims to improve patients' self-efficacy through group discussion and collaborative problem solving. In the third step (educational participation), will try to increase the efficacy through educational participation. . As mentioned in the first step, Participants were asked to Information obtained from meetings and educational pamphlets, available to active members of their family. So to ensure we achieve this goal, the participants requested that with active member be present at the meeting and participate in group discussions and question and answer. The fourth step is evaluation done in two stages. The first stage involve asking two questions orally at the beginning of each session and 	The second stage is the final evaluation that instruments will be completed again by the sample.</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>Leili Borimnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr (AS) –Higher  from Vanak Square - Rashid Street Yasami Faculty of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21</telephone>
        <email>l.borimnejad@gmail.com</email>
        <affiliation>ran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leili borimnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr (AS) –Higher  from Vanak Square - Rashid Street Yasami Faculty of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21</telephone>
        <email>l.borimnejad@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria included: &#13;
• A partnership a family member with patient&#13;
• have at least read and write to the patient and Active member of the family&#13;
• Having Medical records in center&#13;
• Lack of specific mental health problem &#13;
• Ability to participate in the program &#13;
Exclusion criteria included: &#13;
• Unwillingness of the patient and an active member of family to participate in the study.&#13;
• Unwillingness of the patient and an active member of family to participate in Problem solving and training sessions.</inclusion_criteria>
      <agemin>81 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D56.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cooley anaemiaSevere beta thalassaemia Thalassaemia:•intermedia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: these people are selected from specific diseases  Aboureihan center in Bandar Abbas. We give them the tools to complete their And 1.5 months later, without any intervention so that only routine nursing care received, the tools will be completed.</i_keyword>
      <i_keyword>Intervention Group: Sampling available. these people are selected from specific diseases  Aboureihan center in Bandar Abbas. After obtaining the written consent of the subjects in the experimental group, pre-test will be conducted. Empowering patients based on four constructs: knowledge, self-efficacy, training participation and evaluation. The first step (perceived threat) empowerment program will try to increase their knowledge through booklets and group discussion. Thus, based on the number of teenagers, they were divided into groups of 3-5 people. Empowerment programs to suit the needs of the participants every two weeks, three sessions, 30-45 minutes. At this stage, Participants were asked to transfer educational materials that have learned to bring a family member. Therefore, educational pamphlets given to them To be an active member of family.  That study and questions that come to mind, write in a sheet and the next meeting, deliver researcher. Therefore, the next meeting will review all comments. . During the second step (self-efficacy), aims to improve patients' self-efficacy through group discussion and collaborative problem solving. In the third step (educational participation), will try to increase the efficacy through educational participation. . As mentioned in the first step, Participants were asked to Information obtained from meetings and educational pamphlets, available to active members of their family. So to ensure we achieve this goal, the participants requested that with active member be present at the meeting and participate in group discussions and question and answer. The fourth step is evaluation done in two stages. The first stage involve asking two questions orally at the beginning of each session and 	The second stage is the final evaluation that instruments will be completed again by the sample.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>General self- efficacy. Timepoint: Before the intervention, after the intervention. Method of measurement: Schwarzer General Self-Efficacy Scale( GSE-10).</prim_outcome>
      <prim_outcome>Disease-related self-efficacy. Timepoint: Before the intervention, after the intervention. Method of measurement: Sickle Cell Self-Efficacy Scale(SCSES).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-01-14</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Blvd, Qods St., Central University Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
