<?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>IRCT20210422051045N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-28</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of improving diabetes health literacy on self-efficacy and social anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of educational program to improving health literacy based on Bandura's learning-cognitive theory on self-efficacy and social anxiety in adolescents with type 1 diabetes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55871</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In this study, health literacy constructs  based on the Bandura's social learning theory will be taught, Randomization description: Simple randomization. In this method, the name of each of the adolescents with type 1 diabetes in each group is poured into a ball separately, and finally the members of each group are determined completely randomly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 1 Diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: The present study is a quasi-experimental study and has an intervention group of 30 adolescents with type 1 diabetes who meet the inclusion criteria. The content of the training, scenarios and games designed by 10 professors, psychologists and pediatric endocrinologists and subspecialists will be validated using authoritative scientific sources and during 4 consecutive training sessions for 4 days for 60 to 90 minutes using Learning methods of lectures, questions and answers, role play, games, use of pictures and educational clips (based on Bandura's social learning theory) will be held completely virtually through Skyroom. The first to fourth sessions will be related to nutrition, exercise, insulin therapy, blood sugar self-monitoring and follow-up, respectively. Intervention 2: Control group: The present study is a quasi-experimental study and has a control group of 30 adolescents with type 1 diabetes who meet the inclusion criteria. Before performing the intervention, a pre-test was taken from the control group at the same time as the intervention group. There was no intervention in this group. One month after the intervention in the intervention group, a post-test was taken from this group at the same time as the intervention group.</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 identifying the individuals, the overall results will be published in a file format.

When:
Access period starts 6 months after the results are published

To whom:
Research subjects and research team

Conditions:
No other analysis is allowed by people other than the research team.

Where to obtain:
Contact with project manager: Vida Rahimi Hassanabad
09229832590

How to obtain:
Have a study permit

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vida Rahimi hassanabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 62, School of Nursing and Midwifery Tehran University of Medical Sciences, Mirkhani St., Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>vida.rahimi13@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jamaladin Begjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 62, School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani St., Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6693 7120</telephone>
        <email>jamalbegjani@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 15-18 years
Willingness to participate in the study
Confirmation of type 1 diabetes by an endocrinologist
Literate
Has the ability to talk and communicate
Native to Tehran</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute and debilitating complications of the disease
Having a chronic illness other than diabetes
Having a mental illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: The present study is a quasi-experimental study and has an intervention group of 30 adolescents with type 1 diabetes who meet the inclusion criteria. The content of the training, scenarios and games designed by 10 professors, psychologists and pediatric endocrinologists and subspecialists will be validated using authoritative scientific sources and during 4 consecutive training sessions for 4 days for 60 to 90 minutes using Learning methods of lectures, questions and answers, role play, games, use of pictures and educational clips (based on Bandura's social learning theory) will be held completely virtually through Skyroom. The first to fourth sessions will be related to nutrition, exercise, insulin therapy, blood sugar self-monitoring and follow-up, respectively.</i_keyword>
      <i_keyword>Control group: The present study is a quasi-experimental study and has a control group of 30 adolescents with type 1 diabetes who meet the inclusion criteria. Before performing the intervention, a pre-test was taken from the control group at the same time as the intervention group. There was no intervention in this group. One month after the intervention in the intervention group, a post-test was taken from this group at the same time as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health literacy score in the health literacy questionnaire of adolescents with diabetes. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Health Literacy Questionnaire for Adolescents with Diabetes.</prim_outcome>
      <prim_outcome>Functional self-efficacy score in the Diabetes Functional Self-efficacy Questionnaire. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Functional self-efficacy questionnaire in diabetes.</prim_outcome>
      <prim_outcome>Social Anxiety Score in Paklak Adolescent Social Anxiety Questionnaire. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Paklak Social Anxiety 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-27</approval_date>
        <contact_name>Ethics Committee of the School of Nursing and Midwifery, Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery Tehran University of Medical Sciences, Mirkhani Street, Tohid square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
