<?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>IRCT201105314443N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-04-18</date_registration>
      <primary_sponsor>Tehran University Of Medical Sciences</primary_sponsor>
      <public_title>The effect of self management program on hypertensive patients  control</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self management program on control of disease and self efficacy in hypertensive patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4746</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>primary hypertension.</hc_freetext>
      <i_freetext>Intervention 1: The control group received only usual care included drug therapy and advise to low salt and low fat regime. Intervention 2: In experiment group, in addition to receiving the usual care group will participate in self management program. self management program with a day 4-hour workshop shall be conducted with patients with primary hypertension, in its first workshop and its objectives are described and will interact with participant ( formation of patient-provider partnership skill). Then educational materials about the nature of the disease, hypertension, risk factors, complications and control procedures, and complications of drug therapy (medical management areas), strengthening behavior and changes in health behavior (role management areas) and methods of stress reduction and management emotions such as anger, fear and despair, and ... (emotional management) by the researcher to speak at 100 minutes in two 50-minute rest period between the two lectures will be presented in 15 minutes. The second part of workshop, which takes 2 hours, then will designed Scenarios in relation to situations where patients with hypertension, may be faced with it, and discussion in small groups, patient information used in the workshop and Finally, is characterized by the correct way to handle situations designed to strengthen problem-solving skills, decision making skills. Also in workshop in the correct way to measure blood pressure, patients are taught and practiced and will ensure that the patient is taught how to correctly measure your blood pressure. The intervention focused on increasing acceptance of diet, nutrition, weight loss, reduced sodium intake, regular physical activity of moderate (walking every day) and smoking cessation and medication regimen is adhered.</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>Masoumeh ZakeriMoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>zakerimo@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Zakerimoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>zakerimo@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>An inclusion criteria: tend to have participated in the study; 69-30 years old ;There Hypertension the mild and moderate (180-140mmhg systolic blood pressure and diastolic blood pressure between 110 to 90), which is confirmed by medical experts; not at the stage of acute disease; The ability to have a conversation in Farsi; read and write ; to establish direct telephone contact with the patient's home is there; difficulties in communication (hearing, etc.) is not; Hard and the underlying disease is not terminal: Such as metastatic cancer, kidney failure); Exclusion criteria: the patient dies during the study; stage of disease is acute and severe</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>69 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group received only usual care included drug therapy and advise to low salt and low fat regime</i_keyword>
      <i_keyword>In experiment group, in addition to receiving the usual care group will participate in self management program. self management program with a day 4-hour workshop shall be conducted with patients with primary hypertension, in its first workshop and its objectives are described and will interact with participant ( formation of patient-provider partnership skill). Then educational materials about the nature of the disease, hypertension, risk factors, complications and control procedures, and complications of drug therapy (medical management areas), strengthening behavior and changes in health behavior (role management areas) and methods of stress reduction and management emotions such as anger, fear and despair, and ... (emotional management) by the researcher to speak at 100 minutes in two 50-minute rest period between the two lectures will be presented in 15 minutes. The second part of workshop, which takes 2 hours, then will designed Scenarios in relation to situations where patients with hypertension, may be faced with it, and discussion in small groups, patient information used in the workshop and Finally, is characterized by the correct way to handle situations designed to strengthen problem-solving skills, decision making skills. Also in workshop in the correct way to measure blood pressure, patients are taught and practiced and will ensure that the patient is taught how to correctly measure your blood pressure. The intervention focused on increasing acceptance of diet, nutrition, weight loss, reduced sodium intake, regular physical activity of moderate (walking every day) and smoking cessation and medication regimen is adhered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Control of disease. Timepoint: before and after intervention. Method of measurement: control of disease questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self efficacy. Timepoint: before and after intervention. Method of measurement: self efficacy questionnaire.</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>Tehran University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-07-28</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Tohid Square Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
