<?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>IRCT2016011622984N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-16</date_registration>
      <primary_sponsor>Vice Chancellor for research  of  guilan University of Medical Sciences</primary_sponsor>
      <public_title>Effects  of intervention based on the  theory of planned  behavior on improving self-care behavior in hypertension patients.</public_title>
      <acronym>Full blood pressure patients self-care</acronym>
      <scientific_title>A clinical trial study on intervention based on the theory of planned behavior on improving self-care behavior of patients with hypertension in two intervention  and control groups with blood pressure control.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19720</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Choose a health center in the center of the quota by random selection of patients in each health center is a table of random numbers.</study_design>
      <phase>2-3</phase>
      <hc_freetext>hypertention.</hc_freetext>
      <i_freetext>Intervention 1: " Intervention group:&#13;
three educational sessions will be held separately in three different topics,and teaching aids and CD s and pamphlets related to the same session will be used.&#13;
The overall aim of the first session:&#13;
To increase patients' awareness of hypertension and familiarity with examining the current situation in their behaviors associated with blood pressure control&#13;
Session period: 45 minutes&#13;
Educator: researcher&#13;
The overall aim of the second session:&#13;
The patients' familiarity with the outcomes of their lifestyle modification as the main solution to promote self-care behaviors with an emphasis on the structure of the perceived behavioral control in high blood pressure control&#13;
The overall aim of the third session;&#13;
Familiarity with diet plan used in patients with hypertension and to determine and change their attitude toward the use of this diet plan in order to promote appropriate nutritional behavior.&#13;
The main aim of the study is that a program is designed to promote and expand self-care behaviors in controlling blood pressure as the primary outcome variable.&#13;
Educational content of sessions includes general information on high blood pressure (definition, symptoms, complications, prevention and treatment) and an emphasis on self-care behaviors in controlling high blood pressure, such as physical activity, proper nutrition and the use of medication. . Educational materials including pamphlets and posters and educational CD will be used in each session. Educational methods used in the sessions will be as a combination of lecture, question and answer, group discussion and brainstorming.". Intervention 2: "control group: In the control group,no educational intervention performed by the researcher. The control group did not receive any intervention by the researcher and the 2.5 month training package that was given to the intervention group was the control group ".</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>  Investigating the effect of intervention based on preplanned behavior theory on enhancing self-care behavior of patients with hypertension (high blood pressure) visiting rural health-care systems of Rasht in 2014&lt;br /&gt;&#13;
1- Fardin Mehrabian, 2- Rabiollah Farmanbar, 3- Marjan Mahdavi Roshan, 4- Saeid Omidi, 5- Roqayeh Aghebati&lt;br /&gt;&#13;
Abstract&lt;br /&gt;&#13;
High blood pressure (BP) is one of the most important threats to the human health, especially in developing countries. According to reports of the World Health Organization (WHO) high BP is the cause of one of each eight cases of mortality and is considered to be the third fatal factor in the world. Therefore, controlling high BP through self-care behaviors is of considerable importance in minimizing the risk of consequences caused by hypertension. Thus, the present paper aims to investigate the effect of intervention based on preplanned behavior theory on enhancing self-care behavior of patients with hypertension. &lt;br /&gt;&#13;
Method&lt;br /&gt;&#13;
This intervention study is performed on patients visiting health-care centers number 13 and 14 in Rasht in two intervention and control groups. Individuals are selected through quota sampling from three health-care centers and random sampling from each. Research tool is a questionnaire containing 40 questions validity of which was determined through Panel Data and its internal reliability was obtained to be α = 0.71. Obtained data was analyzed using SPSS software and descriptive and inferential in two steps before and 2.5 months after educational interventions. &lt;br /&gt;&#13;
Results&lt;br /&gt;&#13;
Women and men composed 76% and 24% of the total population, respectively, with average age of 56.08 years and standard deviation of 6.11. Multivariable regression analysis revealed that controlling the perceived behavior and attitude predict behavioral intention in controlling BP among visited patients (p &lt; 0.003, R2 = 0.21), so that an increase in control of perceived behavior and then the attitude, enhance behavioral intention in self-care behavior. Hence, considering predictive constructs and educational interventions, results indicate a significant increase in constructs of preplanned behavior theory (respecting p &lt; 0.001) and a considerable enhancement in self-care behavior in the field of physical activity and controlled feeding. &lt;br /&gt;&#13;
Conclusion&lt;br /&gt;&#13;
Based on research findings and studying patients' present status, it is necessary to have more training on enhancing behaviors concerning blood pressure control in this group of patients in order to observe control and reduction of high blood pressure through performing required interventions based on models of health training and enhancement. &lt;br /&gt;&#13;
Keywords: Hypertension; preplanned behavior theory; educational intervention.   &lt;br /&gt;&#13;
1- Associate professor at department of health training and enhancement, faculty of health, Guilan Medical University, Rasht, Iran.&lt;br /&gt;&#13;
2- Associate professor at department of health training and enhancement, faculty of health, Guilan Medical University, Rasht, Iran.&lt;br /&gt;&#13;
3- Assistant professor in nutrition  science .Guilan interventional cardiovascular research center , heshmat hospital ,Guilan University of Medical Sciences, Rasht, Iran.&lt;br /&gt;&#13;
4- Instructor at department of health training and enhancement, faculty of health, Guilan Medical University, Rasht, Iran.&lt;br /&gt;&#13;
5- Graduate of Master's Degree in health Education and health promotion, faculty of health, Guilan Medical University, Rasht, Iran.09116163403&lt;br /&gt;&#13;
                    </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>Roghaye Aghebati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht. namjoo street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41498-35951</zip>
        <telephone>+98 13 3354 8578</telephone>
        <email>r.aghebati44097@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roghaye Aghebati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht, namjo street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41498-35951</zip>
        <telephone>+98 13 3354 8578</telephone>
        <email>raghebati44097@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
People with high blood pressure; People living near health centers of rural areas and having a medical record in the health house; History of hypertension during one year ago; Age above 45 years old and below 65 years old; Patient's participation in research with his (her) satisfaction.&#13;
Exclusion criteria:&#13;
Patient's withdrawal from the study whenever s(he) wants, if (s)he does not want to continue; A life-threatening event or death during conducting intervention programs for patients;</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10-115</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension  Incl.:     High blood pressure     Hypertension (arterial)(benign)(essential)(malignant)(primary)(systemic)  Excl.:     involving vessels of:          brain (I60-I69)         eye (H35.0) -</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:&#13;
three educational sessions will be held separately in three different topics,and teaching aids and CD s and pamphlets related to the same session will be used.&#13;
The overall aim of the first session:&#13;
To increase patients' awareness of hypertension and familiarity with examining the current situation in their behaviors associated with blood pressure control&#13;
Session period: 45 minutes&#13;
Educator: researcher&#13;
The overall aim of the second session:&#13;
The patients' familiarity with the outcomes of their lifestyle modification as the main solution to promote self-care behaviors with an emphasis on the structure of the perceived behavioral control in high blood pressure control&#13;
The overall aim of the third session;&#13;
Familiarity with diet plan used in patients with hypertension and to determine and change their attitude toward the use of this diet plan in order to promote appropriate nutritional behavior.&#13;
The main aim of the study is that a program is designed to promote and expand self-care behaviors in controlling blood pressure as the primary outcome variable.&#13;
Educational content of sessions includes general information on high blood pressure (definition, symptoms, complications, prevention and treatment) and an emphasis on self-care behaviors in controlling high blood pressure, such as physical activity, proper nutrition and the use of medication. . Educational materials including pamphlets and posters and educational CD will be used in each session. Educational methods used in the sessions will be as a combination of lecture, question and answer, group discussion and brainstorming."</i_keyword>
      <i_keyword>"control group: In the control group,no educational intervention performed by the researcher. The control group did not receive any intervention by the researcher and the 2.5 month training package that was given to the intervention group was the control group "</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hypertention. Timepoint: before and 2.5   months after the educational intervention. Method of measurement: Manual gearboxes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Average structures perceived behavioral theory. Timepoint: Before and 2.5 month after intervention. Method of measurement: The questionnaire was created by the researcher.</sec_outcome>
      <sec_outcome>Average physical activity. Timepoint: Before and 2.5 month after intervention. Method of measurement: GPAC Questionnaire.</sec_outcome>
      <sec_outcome>Average use a drug. Timepoint: Before and 2.5 month after intervention. Method of measurement: The questionnaire was created by the researcher.</sec_outcome>
      <sec_outcome>Average food intake and the DASH diet group. Timepoint: Before and 2.5 month after intervention. Method of measurement: FFO   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>Vice Chancellor for research  of  guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-19</approval_date>
        <contact_name>Ethics committee of  Guilan University of Medical Sciences</contact_name>
        <contact_address>Rasht,  in front of stadium Azodi Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
