<?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>IRCT2014113017736N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-15</date_registration>
      <primary_sponsor>Golestan University of Medical Science (Technology and Information Department)</primary_sponsor>
      <public_title>Motivational Interviewing Effects on Hypertensive Patients</public_title>
      <acronym></acronym>
      <scientific_title>Motivational Interviewing Effects on Hypertensive Patients attended to health centers of Gorgan city in 2014</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-02-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16225</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Healthy lifestyle.</hc_freetext>
      <i_freetext>Intervention 1: Control group: the content of this group included the recommendations and information in terms of change healthy lifestyle and adherence to treatment that conducted by a health center staff using a lecture and pamphlet about hypertension for six months (each session sized from 7 to 10 samples and was 30 to 45 minutes and1 session per month). Intervention 2: Motivational interviewing group: the intervention was done through a psychologist who was authorized, each group ranged from 7 to 10 subjects that trained for 6 sessions over six months (45 to 60 minutes for each session). It focused on the behavior change of patients regarding regular physical activity, healthy dietary habits, smoking cessation, reducing stress and taking medication on time. The psychologist asked the participants to record their daily diary, adherence to medication, smoking, dietary habits, physical activity, illness perception, physical and mental health. motivational interviewing session was implemented in the health center.</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>Seyyed Kamal Mirkarimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no 19, 3rd sima alley, Vali-asr street</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 17 3253 2872</telephone>
        <email>k.mirkarimi@goums.ac.ir</email>
        <affiliation>Golestan University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Kamal Mirkarimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no 19- 3rd alley- 57avenue- Gorgan- Golestan province- Iran</address>
        <city>47178</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917</zip>
        <telephone>+98 17 3253 2872</telephone>
        <email>ak.mirkarimi@gmail.com</email>
        <affiliation>Golestan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were as follows: 1) patients diagnosed with hypertension by a physician; 2) patients who received one antihypertensive medication at least; 3) patients who agreed to participate in the survey and more than 18 years old. Excluded criteria were as: 1) pregnant women and being pregnant during the study and 2) secondary hypertensive patients.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>139 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z91.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Maltreatment NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: the content of this group included the recommendations and information in terms of change healthy lifestyle and adherence to treatment that conducted by a health center staff using a lecture and pamphlet about hypertension for six months (each session sized from 7 to 10 samples and was 30 to 45 minutes and1 session per month)</i_keyword>
      <i_keyword>Motivational interviewing group: the intervention was done through a psychologist who was authorized, each group ranged from 7 to 10 subjects that trained for 6 sessions over six months (45 to 60 minutes for each session). It focused on the behavior change of patients regarding regular physical activity, healthy dietary habits, smoking cessation, reducing stress and taking medication on time. The psychologist asked the participants to record their daily diary, adherence to medication, smoking, dietary habits, physical activity, illness perception, physical and mental health. motivational interviewing session was implemented in the health center.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The laboratory and clinical indices (systolic blood pressure, the diastolic blood pressure, triglyceride level and total cholesterol, the symptoms of hypertension, and the complications of hypertension). Timepoint: Baseline (pre-test). Method of measurement: Laboratory and clinical sheet.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Baseline (pre-test). Method of measurement: Blood test, when patient in sitting position, 5 minutes after sitting from the left arm.</prim_outcome>
      <prim_outcome>Treatment Adherence. Timepoint: Baseline (pre-test). Method of measurement: Treatment Adherence Questionnaire of Patients with Hypertension (TAQPH).</prim_outcome>
      <prim_outcome>Demographic status (included age, gender, marital status, educational level and diagnosis duration). Timepoint: Baseline (pre-test). Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: Baseline (pre-test). Method of measurement: General Self-Efficacy Scale (GSES).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Baseline (pre-test). Method of measurement: Medical outcomes study 36- item short form (SF-36).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Follow-up after 6 month. Method of measurement: Medical outcomes study 36- item short form (SF-36).</sec_outcome>
      <sec_outcome>Self-efficacy. Timepoint: Follow-up after 6 month. Method of measurement: General Self-Efficacy Scale (GSES).</sec_outcome>
      <sec_outcome>Treatment Adherence. Timepoint: Follow-up after 6 month. Method of measurement: Treatment Adherence Questionnaire of Patients with Hypertension (TAQPH).</sec_outcome>
      <sec_outcome>The laboratory and clinical indices (systolic blood pressure, the diastolic blood pressure, triglyceride level and total cholesterol, the symptoms of hypertension, and the complications of hypertension(. Timepoint: Follow-up after 6 month. Method of measurement: Laboratory and clinical sheet.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Follow-up after 6 month. Method of measurement: Blood test, when patient in sitting position, 5 minutes after sitting from the left arm.</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>Golestan University of Medical Science (Technology and Information Department)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-01-27</approval_date>
        <contact_name>Golestan University of Medical Science</contact_name>
        <contact_address>4 Kilometer of Gorgan-Sari road, Falsafi educatiobal campus, technology and research department Gorgan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
