<?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>IRCT201703127391N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-28</date_registration>
      <primary_sponsor>Vice Chancellor for research of Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Telenursing And  Pre-hypertension</public_title>
      <acronym></acronym>
      <scientific_title>The Impact Of Telenursing On  Blood Pressure And Body Mass Index Of People With Pre-hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>81</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7839</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>High blood pressure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Subjects participated in a two-hour session (using lecture, PowerPoint) regarding blood pressure, hypertension and its risk factors, and healthy lifestyle. Researcher’s phone number was given to patients, in the experimental group. Phone calls and messages schedule were described to them. The time limit for phone calls and messages were between 8 am to 20 pm. A phone call was made for each patient in a month (call duration was about 15 minutes) ,for two months. Four messages were sent in a week (totally 32). Messages and phone calls were about risk factors of hypertension, reinforce patient’s health behaviors, giving health recommendations. In addition, in the case of occurring a problem or question, patients could contact with researcher. At the end of the study, blood pressure, weight and height were measured and questionnaire was completed again. Intervention 2: Control group: Subjects participated in a two-hour session (using lecture, PowerPoint) regarding blood pressure, hypertension risk factors, and healthy lifestyle. Then after eight weeks, the samples were invited again to complete the questionnaire and measure weight , height and blood pressure.</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>Maryam Eghbali Babadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University Of Medical Science,Hezar Jerib Avenue, Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 7539</telephone>
        <email>eghbali@nm.mui.ac.ir</email>
        <affiliation>Isfahan University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Eghbali Babadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University Of Medical Science,Hezar Jerib Avenue,  Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 7539</telephone>
        <email>eghbali@nm.mui.ac.ir</email>
        <affiliation>Isfahan Univercity Of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: At the time of discharge from emergency department, average SBP during two measurements within two minutes must be in the range of 120 to 139 or average DBP must be in the range of 80 to 89; age range should be 18 to 60; ability to communicate appropriately; not having trouble with hearing and speaking; access to mobile phone and awareness about its use; ability to perform daily activities; ability to read and write; not using blood pressure reducer drugs; no special diet for obesity and thinness; Exclusion criteria: Pregnancy and lactation; disease such as kidney failure and cancer; lack of accountability telephonic communication more than 3 times; unwillingness to continue the cooperation; using any drug during the study; using calming techniques such as yoga; confrontation with severe stress during the intervention period.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R03.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Elevated blood-pressure reading, without diagnosis of hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Subjects participated in a two-hour session (using lecture, PowerPoint) regarding blood pressure, hypertension and its risk factors, and healthy lifestyle. Researcher’s phone number was given to patients, in the experimental group. Phone calls and messages schedule were described to them. The time limit for phone calls and messages were between 8 am to 20 pm. A phone call was made for each patient in a month (call duration was about 15 minutes) ,for two months. Four messages were sent in a week (totally 32). Messages and phone calls were about risk factors of hypertension, reinforce patient’s health behaviors, giving health recommendations. In addition, in the case of occurring a problem or question, patients could contact with researcher. At the end of the study, blood pressure, weight and height were measured and questionnaire was completed again.</i_keyword>
      <i_keyword>Control group: Subjects participated in a two-hour session (using lecture, PowerPoint) regarding blood pressure, hypertension risk factors, and healthy lifestyle. Then after eight weeks, the samples were invited again to complete the questionnaire and measure weight , height and blood pressure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Before  and after Education. Method of measurement: blood pressure measurment device.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: pre and post education. Method of measurement: Weight and Meter.</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 of Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-13</approval_date>
        <contact_name>Ethics Committee Of Isfahan University Of Medical Sciences</contact_name>
        <contact_address>Isfahan University Of Medical Science,Hezar Jerib Avenue, Isfahan, Iran. Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
