<?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>IRCT2014061218076N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-29</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Self-management education programs in promoting healthy behavior patterns and quality of life</public_title>
      <acronym>Self-management of hypertension</acronym>
      <scientific_title>Evaluation of Educational Program Based on "self-management Model" to promotion of healthy behavior among Hypertensive women in Health care centers in Isfahan2015</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16497</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Essential (primary) hypertension.</hc_freetext>
      <i_freetext>Intervention 1: After registration of patients who want to participate in   research projects. The goals and the process of research will be  explained to them.  Patient's informed consent will be filled out. If they have    inclusion criteria, they participate in the study.  Demographic information will be taken. The randomized allocation will be done by The technic of binary block allocation.  75 patients in the intervention group and 75 in control group. 75 patients will be in the intervention group. For the intervention group, the 6 group educational sessions, including 120 minutes will be arranged based on self-care behavior. At the first, intervention group  will be received self-management, and self-monitoring of blood pressure questionnaires. Blood tests, Body Mass Index, blood pressure, quality of life will be measured too. After 1.5 months, the questionnaires will be completed again. Text messages will be given to intervention group based on the training subjects through the cell Phone weekly. After 6 months, Quality of life Inventory, self-management questionnaires will be completed. Clinical blood tests and BMI, blood pressure will be measured.75 patients will be in the intervention group. For the intervention group, the 6 group educational sessions, including 120 minutes will be arranged based on self-care behavior. At the first, intervention group  will be received self-management, and self-monitoring of blood pressure questionnaires. Blood tests, Body Mass Index, blood pressure, quality of life will be measured too. After 1.5 months, the questionnaires will be completed again. Text messages will be given to intervention group based on the training subjects through the cell Phone weekly. After 6 months, Quality of life Inventory, self-management questionnaires will be completed. Clinical blood tests and BMI, blood pressure will be measured. Intervention 2: 75 patients will be in control group.  The control group won't participate in education sessions.    The control group will receive routine education based on health centers program according to national protocols. At the first, control group will receive self-management, and self-monitoring of blood pressure questionnaires. Blood tests, Body Mass Index, blood pressure, and quality of life will be measured too. After 1.5 months, the questionnaires will be completed again.  After 6 months, Quality of life Inventory, self-management questionnaires will be completed. Clinical blood tests and BMI, blood pressure will be m.</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>Seyde Shahrbanoo Daniali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3775 1953</telephone>
        <email>sh_daniali@yahoo.com; sh_daniali@hlth.mui.ac.ir</email>
        <affiliation>Department of health education &amp; health promotion School of health Isfahan University of Medical Sci</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyde Shahrbanoo Daniali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan- School of health ,Isfahan University of Medical Sciences Isfahan,Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174885113</zip>
        <telephone>+98 31 3775 1953</telephone>
        <email>sh_daniali@yahoo.com; sh_daniali@hlth0mui.ac.ir</email>
        <affiliation>Department of health education &amp; health promotion School of health Isfahan University of Medical Sci</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: being interested to participate in the study; being middle-aged (65-30 years old); use drug for treatment of hypertension; the duration of diagnosed hypertension occurred at least for 6 months; not being involved in other common educational program related to hypertension at the same time and at least be literate.&#13;
 Exclusion criteria: the people don't want to continue the cooperation; participants who have attended at least two training sessions.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After registration of patients who want to participate in   research projects. The goals and the process of research will be  explained to them.  Patient's informed consent will be filled out. If they have    inclusion criteria, they participate in the study.  Demographic information will be taken. The randomized allocation will be done by The technic of binary block allocation.  75 patients in the intervention group and 75 in control group. 75 patients will be in the intervention group. For the intervention group, the 6 group educational sessions, including 120 minutes will be arranged based on self-care behavior. At the first, intervention group  will be received self-management, and self-monitoring of blood pressure questionnaires. Blood tests, Body Mass Index, blood pressure, quality of life will be measured too. After 1.5 months, the questionnaires will be completed again. Text messages will be given to intervention group based on the training subjects through the cell Phone weekly. After 6 months, Quality of life Inventory, self-management questionnaires will be completed. Clinical blood tests and BMI, blood pressure will be measured.75 patients will be in the intervention group. For the intervention group, the 6 group educational sessions, including 120 minutes will be arranged based on self-care behavior. At the first, intervention group  will be received self-management, and self-monitoring of blood pressure questionnaires. Blood tests, Body Mass Index, blood pressure, quality of life will be measured too. After 1.5 months, the questionnaires will be completed again. Text messages will be given to intervention group based on the training subjects through the cell Phone weekly. After 6 months, Quality of life Inventory, self-management questionnaires will be completed. Clinical blood tests and BMI, blood pressure will be measured.</i_keyword>
      <i_keyword>75 patients will be in control group.  The control group won't participate in education sessions.    The control group will receive routine education based on health centers program according to national protocols. At the first, control group will receive self-management, and self-monitoring of blood pressure questionnaires. Blood tests, Body Mass Index, blood pressure, and quality of life will be measured too. After 1.5 months, the questionnaires will be completed again.  After 6 months, Quality of life Inventory, self-management questionnaires will be completed. Clinical blood tests and BMI, blood pressure will be m</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: All variables at baseline, 1.5 month latter, and then at the end of 6 months are evaluated. Method of measurement: (mmHg)measured by  Mercury sphygmomanometer.</prim_outcome>
      <prim_outcome>BMI. Timepoint: All variables at baseline, 1.5 month latter, and then at the end of 6 months are evaluated. Method of measurement: calibrated scale and meter.</prim_outcome>
      <prim_outcome>Nutritional status. Timepoint: All variables at baseline, 1.5 month latter, and then at the end of 6 months are evaluated. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: All variables at baseline, 1.5 month latter, and then at the end of 6 months are evaluated. Method of measurement: fatigue visual basic.</prim_outcome>
      <prim_outcome>Pain. Timepoint: All variables at baseline, 1.5 month latter, and then at the end of 6 months are evaluated. Method of measurement: pain visual basic.</prim_outcome>
      <prim_outcome>Physical activity. Timepoint: All variables at baseline, 1.5 month latter, and then at the end of 6 months are evaluated. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Depression. Timepoint: All variables at baseline, 1.5 month latter, and then at the end of 6 months are evaluated. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Paraclinic (Blood)tests:TG,cholestrol,Na of urine(24 hours). Timepoint: at baseline,   and at the end of 6 months are evaluated. Method of measurement: labratory kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: At the begining and 6 months later. Method of measurement: Questionnair QOL36 questions that validited among Iranian.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-01</approval_date>
        <contact_name>Research Assistanceof  Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
