<?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>IRCT20220316054313N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-31</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education on Mean blood pressure and drug adherence in patients with hypertensive crisis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of education on Mean blood pressure and drug adherence in patients with hypertensive crisis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>148</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62585</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Patients are randomly allocated into intervention and control groups. Blocking is used in order to balance the number of samples allocated to each of the studied groups. The size of all the blocks is equal and in this experiment we will have two groups of 4 blocks (including 2 people in the intervention group and 2 people in the control group). R statistical software is used to prepare the randomization list. Before the start of the study, the randomization list was prepared by the professor of statistics and given to the main researcher. Group A and B were written in the envelopes, respectively, and the researcher opened the envelopes during sampling and as soon as each patient entered. will assign the patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertensive crisis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For patients in the intervention group, in the first week after the hypertensive crisis, 2 training sessions for 20-25 minutes will be performed in groups of up to 8 people.The patient's mobile number is taken for follow-up. During the study, the patient is called once a week (4 phone calls during the study).In this call, while re-emphasizing the importance of controlling blood pressure and reminding important issues, patients' questions are answered.At the end of the second, third and fourth weeks, patients' blood pressure will be measured and recorded using a mercury sphygmomanometer. Intervention 2: Control group: These patients, like other patients (in the intervention group), will receive the necessary treatments based on the prescription of the treating physician and will receive training that is done routinely by them.  At this stage, these patients do not receive the training given by the facilitator to the patients in the intervention group. The blood pressure of these patients is taken and recorded at the end of the second, third and fourth weeks. Will be registered.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasrin Amerehgoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payambar Azam University Complex., Basij Sq., Sardasht Town</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3914334911</zip>
        <telephone>+98 86 3417 3505</telephone>
        <email>Namerehgoli72@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kourosh Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payambar Azam University Complex., Basij Sq., Sardasht Town</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3914334911</zip>
        <telephone>+98 86 3417 3505</telephone>
        <email>k.rezaei@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients should be between 18-60 years old
Be able to take care of yourself and take medication
Lack of cognitive and psychological problems
According to the patient, the patient should not have secondary hypertension.
Be literate and speak Persian.
Do not have a heart attack, stroke, transient ischemic attack, kidney disorders, heart failure, or be pregnant.
Systolic or diastolic blood pressure should be 120/180 or more
No financial problems to prepare and use medicine based on the patient's statement.
Do not take NSAIDs, glucocorticoids, antidepressants, caffeine, nicotine and licorice
Lack of resistance to treatment in a person with high blood pressure</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who die after training
Patients who develop cardiopulmonary arrest after training or need intervention methods (angiography or angioplasty), or surgery (heart, brain ...).
Existence of resistance to treatment
Administration of any of the NSAIDs, glucocorticoids, antidepressants, caffeine, nicotine and licorice during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I15.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other secondary hypertension</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: For patients in the intervention group, in the first week after the hypertensive crisis, 2 training sessions for 20-25 minutes will be performed in groups of up to 8 people.The patient's mobile number is taken for follow-up. During the study, the patient is called once a week (4 phone calls during the study).In this call, while re-emphasizing the importance of controlling blood pressure and reminding important issues, patients' questions are answered.At the end of the second, third and fourth weeks, patients' blood pressure will be measured and recorded using a mercury sphygmomanometer.</i_keyword>
      <i_keyword>Control group: These patients, like other patients (in the intervention group), will receive the necessary treatments based on the prescription of the treating physician and will receive training that is done routinely by them.  At this stage, these patients do not receive the training given by the facilitator to the patients in the intervention group. The blood pressure of these patients is taken and recorded at the end of the second, third and fourth weeks. Will be registered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: End of the second, third and fourth week. Method of measurement: Mm Hg using a sphygmomanometer.</prim_outcome>
      <prim_outcome>Drug adherence. Timepoint: One month after the intervention. Method of measurement: Girerd Drug Adherence Questionnaire.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-22</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Khatam Al-Anbia University Complex., Basij Sq., Sardasht Town Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
