<?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>IRCT20170619034641N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-28</date_registration>
      <primary_sponsor>معاونت تحقیقات و فناوری دانشگاه علوم پزشکی کرمانشاه</primary_sponsor>
      <public_title>Assessing the Effect of Educational Intervention in  metabolic indices of diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>Assessing the Effect of Educational Intervention Based on Health Belief Model in improving metabolic indices of type2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28023</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The patients Will be selected randomly from one or two villages (as needed) and the patients of the  one or two other villages are considered as the control group randomly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: educational intervention will be conducted  weekly during 6 sessions (60 minutes) with a designed program according to the Health Belief Model. this intervention will be implemented in three stages. the first stage consists of one session, the goal of this stage is to increase the susceptibility to diabetes complications. topics to be considered at this meeting including the acquaintance of patients with the nature of diabetes and its complications, the definition of diabetes control and the importance of monitoring blood glucose. the second stage consists of three sessions, the goal of this stage is to increase perceptions of the benefits and obstacles, adhering to diet, drug orders and physical activity. the third stage consists of two sessions with the goal of facilitating and encouraging patients to perform their intended behavioral goals and enhancing their self-efficacy by inviting a successful diabetic patient and an active family member. Intervention 2: Control group: The control group receives only routine training during this time.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>alireza abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00988338279394</zip>
        <telephone>+98 83 3835 8258</telephone>
        <email>arabdi@kums.ac.ir</email>
        <affiliation>Kermanshah School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>alireza abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00988338279394</zip>
        <telephone>+98 83 3835 8258</telephone>
        <email>arabdi@kums.ac.ir</email>
        <affiliation>Kermanshah School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include: at least one year have passed from a definitive diagnosis of type 2 diabetes, being in the age group of 30 to 65 years old, their HbA1c test is equal  or higher than 7% and no perceptual problem.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria include: patients who do not attend more than one session in the educational intervention, patients who do not perform the required tests completely and Patients who are not willing to cooperate in the study anyway.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: educational intervention will be conducted  weekly during 6 sessions (60 minutes) with a designed program according to the Health Belief Model. this intervention will be implemented in three stages. the first stage consists of one session, the goal of this stage is to increase the susceptibility to diabetes complications. topics to be considered at this meeting including the acquaintance of patients with the nature of diabetes and its complications, the definition of diabetes control and the importance of monitoring blood glucose. the second stage consists of three sessions, the goal of this stage is to increase perceptions of the benefits and obstacles, adhering to diet, drug orders and physical activity. the third stage consists of two sessions with the goal of facilitating and encouraging patients to perform their intended behavioral goals and enhancing their self-efficacy by inviting a successful diabetic patient and an active family member.</i_keyword>
      <i_keyword>Control group: The control group receives only routine training during this time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Glycated haemoglobin (HbA1c). Timepoint: Before the intervention and three months after the intervention. Method of measurement: A1C care device.</prim_outcome>
      <prim_outcome>Fasting blood sugar (FBS). Timepoint: Before the intervention and three months after the intervention. Method of measurement: AutoAnalyzer.</prim_outcome>
      <prim_outcome>Triglyceride (TG). Timepoint: AutoAnalyzer. Method of measurement: AutoAnalyzer.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Before the intervention and three months after the intervention. Method of measurement: AutoAnalyzer.</prim_outcome>
      <prim_outcome>High-density lipoprotein (HDL). Timepoint: Before the intervention and three months after the intervention. Method of measurement: AutoAnalyzer.</prim_outcome>
      <prim_outcome>Low-density lipoprotein (LDL). Timepoint: Before the intervention and three months after the intervention. Method of measurement: AutoAnalyzer.</prim_outcome>
      <prim_outcome>Perceived Susceptibility. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Health belief model researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Perceived Severity. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Health belief model researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Perceived Barriers. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Health belief model researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Perceived Benefits. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Health belief model researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Cues to action. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Health belief model researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Health belief model researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Body mass index (BMI). Timepoint: Before the intervention and three months after the intervention. Method of measurement: DETECTO-MEDIC Height and Weight Measurement Device.</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>معاونت تحقیقات و فناوری دانشگاه علوم پزشکی کرمانشاه</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-25</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshty BLV., Kermanshah University of Medical Sciences, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
