<?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>IRCT20190626044026N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-14</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational software application based on mobile base learning  on blood pressure and quality of life of military men with hypertension</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational software application based on mobile base learning  on blood pressure and quality of life of military men with hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40920</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The study is a randomized clinical trial. We will have two intervention and control groups. The intervention group received the app in addition to the hospital training but the control group received only the hospital training, Randomization description: In this study, the samples were first selected easily among militants with hypertension (based on the approval of an internal medicine specialist) who have criteria for entering the research and then assigned randomly into two groups of test and control. In this way, envelopes containing cards with A and C adhesives will be requested and the military personnel will be required to randomly select one of the envelopes, those who will receive the A card, in the test group and those who have the card C will be assigned to the control group. Thus sampling will continue until the sample size is determined, the researcher will consider the dropping of samples according to the specified exit rates.</study_design>
      <phase>N/A</phase>
      <hc_freetext>blood pressure.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group: "in the first step, the researcher will collect and compile content based on the library studies and the Global Guide to the Management and Treatment of Blood Pressure and Search in Valid Databases and Scientific Articles by the Researcher in order to gather the contents for the desired software. Various hypertension topics include caring topics including nutrition, exercise, diet and medication, risk factors, which are technically and scientifically approved by the Faculty of Nursing of the Army University, Internal and Cardiovascular Specialists, Shahid Medical Center Health Education Committee. Civil will arrive in Khorramabad city The capabilities of the educational software of interest to the researcher will be presented to the programming engineer and according to those features the appropriate software will be designed by the programming engineer. The software will be Android-based and will be designed to be used offline. The software will be installed on the intervention group's smartphone and the researcher will be given a lecture and practical information in a 60-minute session of the software's features and how to use it in coordination with the hospital training supervisor in the training center conference hall. They will be. Also, at the end of the training session on using the software, patients will be asked to work with the software in practice and to see if the researcher has learned to work with the software to ask questions in case of any ambiguity. The patients' blood pressure will be measured before intervention in the intervention group and their demographic questionnaire will be filled out. Software will be installed in the intervention group's patients for six weeks and patients will be required to use this software and program after six weeks. This group will be measured and their demographic and quality of life questionnaire will be filled after the intervention. Intervention 2: "Control group:"Routine care.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information "</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshteh Falah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadi Alley;Karim khan Ave</address>
        <city>Khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819755836</zip>
        <telephone>+98 66 3342 1427</telephone>
        <email>falahfereshteh407@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fereshteh Falah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadi alley;Karimkhan Ave</address>
        <city>Khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819755836</zip>
        <telephone>+98 66 3342 1427</telephone>
        <email>falahfereshteh407@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of blood pressure by the physician
Excellent 35-55 years
No occupation of the patient or family member in the medical staff
No admission to different parts of the hospital after completion of treatment
Lack of hearing impairment, vision
Minimum reading and writing comprehension
Access to the mobile phone and the ability to use it
The ability to install a mobile phone app</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unwillingness to participate in the study</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group: "in the first step, the researcher will collect and compile content based on the library studies and the Global Guide to the Management and Treatment of Blood Pressure and Search in Valid Databases and Scientific Articles by the Researcher in order to gather the contents for the desired software. Various hypertension topics include caring topics including nutrition, exercise, diet and medication, risk factors, which are technically and scientifically approved by the Faculty of Nursing of the Army University, Internal and Cardiovascular Specialists, Shahid Medical Center Health Education Committee. Civil will arrive in Khorramabad city The capabilities of the educational software of interest to the researcher will be presented to the programming engineer and according to those features the appropriate software will be designed by the programming engineer. The software will be Android-based and will be designed to be used offline. The software will be installed on the intervention group's smartphone and the researcher will be given a lecture and practical information in a 60-minute session of the software's features and how to use it in coordination with the hospital training supervisor in the training center conference hall. They will be. Also, at the end of the training session on using the software, patients will be asked to work with the software in practice and to see if the researcher has learned to work with the software to ask questions in case of any ambiguity. The patients' blood pressure will be measured before intervention in the intervention group and their demographic questionnaire will be filled out. Software will be installed in the intervention group's patients for six weeks and patients will be required to use this software and program after six weeks. This group will be measured and their demographic and quality of life questionnaire will be filled after the intervention.</i_keyword>
      <i_keyword>"Control group:"Routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: Pressure measurement before and 6 weeks after the study. Method of measurement: Mercury barometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Life quality. Timepoint: Before the study and 6 weeks after the study. Method of measurement: Sf-36 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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-30</approval_date>
        <contact_name>Ethics committee of aja University of Medical Sciences</contact_name>
        <contact_address>Sadi Alley; Karim khan Ave; Khoramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
