<?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>IRCT201409094655N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-25</date_registration>
      <primary_sponsor>Kashan Medical University</primary_sponsor>
      <public_title>Effect of education based on Baznef  model on blood pressure and lifestyle in patient with hypertension.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of education based on Baznef  model on blood pressure and lifestyle in patient with hypertension.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4987</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Individuals in the intervention and control groups, randomly allocated blocks (blocks 4-procurement and selection will be based on them).</study_design>
      <phase>N/A</phase>
      <hc_freetext>HYPERTENSION.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention Group: Training is done in accordance with BASNEF model as a group. The program is based on the structures BASNEF model within 5 sessions 45-60 minute (2 sessions per week) for 6-4 for each group of 6-4 people with discussion and questions and answers in health centers will be done. In the first and second sessions, on signs, symptoms and lifestyle modification (nutrition, smoking cessation and smoking, stress reduction, weight loss, physical activity, etc.), the importance of regular drug use and side effects will be discussed And the third and fourth sessions of group training on the proper method of blood pressure and control blood pressure need to be allocated. To repeat, educational pamphlet designed to deliver a literate family members to read at home for the patient. According BASNEF model a meeting (Fifth session) attended by influential people on life (including spouse, child or important person in life) and the research team and other personnel for their effects on blood pressure and harmful behaviors will be held . Blood pressure in the intervention group, compliance with all criteria of 7 JNC, before, during (weeks 1, 3 and 5 baseline) and 1 month after intervention by the nurses certified for single-blind (The patient does not know the manner and type of education by the nurse is measured.". Intervention 2: " control group: common training in health centers to receive routine before. In addition, Their blood pressure, compliance with all criteria of 7 JNC, before, during (weeks 1, 3 and 5 baseline) and 1 month after 1 month after completion of the training group, by the nurses certified for single-blind (The patient does not know the manner and type of education by the nurse) is measured.".</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>Taghadosi Mohsen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arctic Blvd Ravandi - Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/81151</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>Taghadosi_m@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Taghadosi Mohsen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arctic Blvd Ravandi - Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/81151</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>Taghadosi_m@kaums.ac.ir</email>
        <affiliation>Faculty of Nursing &amp; Midwifery,Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
The desire to participate in the study; primary hypertension (high blood pressure that has no known cause); age of 65-18 years; they have at least 6 months of diagnosis; Ability to understand and speak; The lack of physical and mental debilitating diseases known; be able to understand and speak the Persian language; Patients who score their lifestyle, according to Life Style Questionnaire (LSQ) is less than 170.&#13;
Exclusion criteria:&#13;
unwillingness to continue the study; participate in the study or other training courses during study; The absence of training sessions (one session and more); joint disease or condition during the study's lead to hospitalization; Change in dosage or type of medication therapy during the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>ICD-10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</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: Training is done in accordance with BASNEF model as a group. The program is based on the structures BASNEF model within 5 sessions 45-60 minute (2 sessions per week) for 6-4 for each group of 6-4 people with discussion and questions and answers in health centers will be done. In the first and second sessions, on signs, symptoms and lifestyle modification (nutrition, smoking cessation and smoking, stress reduction, weight loss, physical activity, etc.), the importance of regular drug use and side effects will be discussed And the third and fourth sessions of group training on the proper method of blood pressure and control blood pressure need to be allocated. To repeat, educational pamphlet designed to deliver a literate family members to read at home for the patient. According BASNEF model a meeting (Fifth session) attended by influential people on life (including spouse, child or important person in life) and the research team and other personnel for their effects on blood pressure and harmful behaviors will be held . Blood pressure in the intervention group, compliance with all criteria of 7 JNC, before, during (weeks 1, 3 and 5 baseline) and 1 month after intervention by the nurses certified for single-blind (The patient does not know the manner and type of education by the nurse is measured."</i_keyword>
      <i_keyword>" control group: common training in health centers to receive routine before. In addition, Their blood pressure, compliance with all criteria of 7 JNC, before, during (weeks 1, 3 and 5 baseline) and 1 month after 1 month after completion of the training group, by the nurses certified for single-blind (The patient does not know the manner and type of education by the nurse) is measured."</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Life style. Timepoint: Baseline and 1 month after intervention. Method of measurement: lifestyle questionnaire.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Baseline, weeks 1, 3, 5 and 1 month after the intervention. Method of measurement: In compliance with all standards of JNC 7 using a mercury manometer adults model F.BOSCH (GERMANY), which was calibrated with mercury healthy.</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>Kashan Medical University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-22</approval_date>
        <contact_name>Kashan University of Medical Sciences</contact_name>
        <contact_address>Arctic Blvd Ravandi - Kashan University of Medical Sciences kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
