<?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>IRCT2016082412264N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-20</date_registration>
      <primary_sponsor>Vice-Chancellor for Research Deputy in Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention on management of Blood Glucose and Confidence in Self-Care in patients with type 2 Diabetes by using face to face training and educational film: A randomised controlled clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational intervention on management of Blood Glucose and Confidence in Self-Care in patients with type 2 Diabetes by using face to face training and educational film: A randomised controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>192</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12365</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Randomization: In this study, type of interventions order will be determined based on random numbers and the invisible envelope will be recorded.  Whenever the number of new members (registered) reached twenty, a parcel (by the secretary of the center) is removed and it will be determined according to the type of intervention. Interventions presenter, will not be notified orders of packets until classes start time to assign people randomly occur. When Face-to-face group or Movie group terms arrive People will have determined with the numbers one to twenty. Then people with drawing, will dividing into four group with five members.</study_design>
      <phase>2</phase>
      <hc_freetext>Type 2 diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: Intervention in face to face training group will take place by using equipment needed by the researcher. in a 30-minute session, as a group (4-5 people) in the Diabetes Association, quiet and equipped with teaching aids, and researcher entire process with a glucometer, Flex Penn and correct principles of using and Insulin injections on models and practically will train and at the end of the session, the patients are given enough time for questions and answers and practical training. Intervention 2: Intervention 2: In groups of videos, tutorials in terms of screening to patients, in groups (4-5 Members) will be provided. A film that is 22 minutes of Tutorials Video Film of Pars NovoNordisk company, Beuerr company and Aparat website. Content of this group with content of face to face training group are matches. Researcher by using film, all the content in a simple language and native participants will explain to patients. Watch Tutorials Video Film in place of quiet Diabetes Association and will be equipped with audio-visual equipment’s. At the end of the session, patients are given enough time for questions and answers.  Researcher will explain all the content in a simple language and native participants by using film, to patients. Play backing will be in Diabetes Association that is quiet place and equipped with audio-visual equipment’s. At the end of the session the patient enough time for questions and answers will be given. Intervention 3: Intervention 3: In the control group, the patients will receive Routine training of the center that is lectures. Researcher will be presented, the previous educational content, in the form of lectures as a groups with 30 minutes’ time length. Lecture will take place in a peaceful environment in the Diabetes Association and at the end of the session, patients are given enough time for questions and answers.</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>Farahnaz Abdollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Dormitory, Shariati Avenue.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3479 6707</telephone>
        <email>abdollahzadehf@tbzmed.ac.ir</email>
        <affiliation>Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farahnaz abdollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Dormitory, Shariati Avenue.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3479 6707</telephone>
        <email>abdollahzadehf@tbzmed.ac.ir</email>
        <affiliation>Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria : The patient has primary education is minimal; The patient is a resident of Tabriz; The patient's age is between 40 and 70; Patients are under insulin treatment; The patient is not suffering from mental illness; The patient is willing to participate in the study; The patient has recently joined to Diabetes Society.&#13;
Exclusion criteria: membership one of the family members in health care team; patient's absence from training sessions; infection or having surgery.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10, E11, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: Intervention in face to face training group will take place by using equipment needed by the researcher. in a 30-minute session, as a group (4-5 people) in the Diabetes Association, quiet and equipped with teaching aids, and researcher entire process with a glucometer, Flex Penn and correct principles of using and Insulin injections on models and practically will train and at the end of the session, the patients are given enough time for questions and answers and practical training.</i_keyword>
      <i_keyword>Intervention 2: In groups of videos, tutorials in terms of screening to patients, in groups (4-5 Members) will be provided. A film that is 22 minutes of Tutorials Video Film of Pars NovoNordisk company, Beuerr company and Aparat website. Content of this group with content of face to face training group are matches. Researcher by using film, all the content in a simple language and native participants will explain to patients. Watch Tutorials Video Film in place of quiet Diabetes Association and will be equipped with audio-visual equipment’s. At the end of the session, patients are given enough time for questions and answers.  Researcher will explain all the content in a simple language and native participants by using film, to patients. Play backing will be in Diabetes Association that is quiet place and equipped with audio-visual equipment’s. At the end of the session the patient enough time for questions and answers will be given</i_keyword>
      <i_keyword>Intervention 3: In the control group, the patients will receive Routine training of the center that is lectures. Researcher will be presented, the previous educational content, in the form of lectures as a groups with 30 minutes’ time length. Lecture will take place in a peaceful environment in the Diabetes Association and at the end of the session, patients are given enough time for questions and answers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average daily blood sugar. Timepoint: One week before intervention and one month after intervention for a week. Method of measurement: By using Beurer Glucometer.</prim_outcome>
      <prim_outcome>Confidence in Self-Care. Timepoint: One week before intervention and one month after intervention for a week. Method of measurement: Confidence in Self-Care Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glycosylated hemoglobin. Timepoint: The last test before the intervention and after the intervention first test. Method of measurement: By using Glycated Hemoglobin detection kit.</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 Deputy in Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-10</approval_date>
        <contact_name>Ethics Committee of Tabriz University of medical sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
