<?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>IRCT2013111215390N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-24</date_registration>
      <primary_sponsor>Vice chancellor for research, Urmia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of tele-education on Laboratory parameters of patients with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of tele-education by telephone and short message service on Laboratory parameters in type 2 diabetic patients who refer to Urmia Diabetes Association in 2011</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14657</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: For sampling, initially a sampling frame of patients who met inclusion criteria have been provided, then by using random number table 66 patients were selected randomly among them. Then the patients allocated in two intervention and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Non-insulin-dependent diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Education by Telephone intervention was carried out for three months. In this case, telephone calls for follow up and education were established by the researcher for every participant twice a week.  The time for Telephone calls was determined between 8 Am to 10 Pm with the agreement of the patients. The average call duration was considered about 20 minutes. The content of telephone conversations, including the assessment of glycemic control status in the field of diet, exercise, blood glucose self-monitoring and medication. And if there is a failure of glycemic control, the situation analyzed with participants’ help to find the problem, eventually providing suggested solution to the patient for solving the problem and answering patient questions. In education by mobile phone (SMS) messages regarding the self-care education (diet, exercise, self-monitoring of blood glucose, foot care and medication) was sent. Every day, a message was sent to participants, so that in three months, 90 text messages were sent. Intervention 2: No intervention carried out in control 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naser Parizad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>11th kilometer of Sero Road, Nazloo Pardis, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44 1275 4964</telephone>
        <email>parizad.n@umsu.ac.ir</email>
        <affiliation>Nursing and Midwifery faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Masumeh Hemmati Maslakpak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>11th kilometer of Sero Road, Nazloo Pardis, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44 1275 4963</telephone>
        <email>hemmati_m@umsu.ac.ir</email>
        <affiliation>Urmia Nursing and Midwifery Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Being able to read and write, age (18-55 years old), being satisfied to participate in the study , diabetes of these patients has been confirmed by specialist and having mobile phone. &#13;
Exclusion criteria:&#13;
Patients with secondary problems such as a history of mental illness, high blood pressure and chronic renal disease, heart disease, and illiterate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Education by Telephone intervention was carried out for three months. In this case, telephone calls for follow up and education were established by the researcher for every participant twice a week.  The time for Telephone calls was determined between 8 Am to 10 Pm with the agreement of the patients. The average call duration was considered about 20 minutes. The content of telephone conversations, including the assessment of glycemic control status in the field of diet, exercise, blood glucose self-monitoring and medication. And if there is a failure of glycemic control, the situation analyzed with participants’ help to find the problem, eventually providing suggested solution to the patient for solving the problem and answering patient questions. In education by mobile phone (SMS) messages regarding the self-care education (diet, exercise, self-monitoring of blood glucose, foot care and medication) was sent. Every day, a message was sent to participants, so that in three months, 90 text messages were sent.</i_keyword>
      <i_keyword>No intervention carried out in control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting Blood Sugar. Timepoint: Before the intervention and three months after the intervention. Method of measurement: By Enzymatic method (mg/dl).</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Before the intervention and three months after the intervention. Method of measurement: By Enzymatic method (mg/dl).</prim_outcome>
      <prim_outcome>The glycosylated hemoglobin. Timepoint: Before the intervention, and three months after intervention. Method of measurement: By Calories metric method (mg/dl).</prim_outcome>
      <prim_outcome>Insulin serum. Timepoint: Before the intervention, and three months after the intervention. Method of measurement: By Elisa Method (ng/mL).</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>Vice chancellor for research, Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-12-03</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Jahad Ave., Resalat Blvd., Urmia, Iran Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
