<?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>IRCT20230706058688N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the impact of education on high-risk patients, their families and pre-hospital emergency personnel</public_title>
      <acronym></acronym>
      <scientific_title>The effect of education to high-risk patients, their families and pre-hospital emergency personnel about strokes on patients’ timely referral to the hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>1000</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71136</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Community-based randomized trial, Randomization description: A cluster sampling method will be used in which one of four urban centers and nearby rural centers will be randomly selected as the intervention group and other centers will be included as the control group, Blinding description: The intervention group (including high-risk patients and their families in the selected cluster which is selected randomly out of 4 centers in Shahindej  city) and the main researcher will know the center which is trained about the timely referral of suspected stroke patients to the hospital. But the data recorders (pre-hospital emergency personnel and emergency ward personnel of Shahin Dej Hospital) are unaware of whether the referred patients are in the intervention group or the control group, and the analyzers also do not know the grouping of the patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the case of high-risk patients, the intervention is in the form of educational sessions and using slides in the simple and native language of the region as far as the audience can understand, as well as the use of educational animations in humorous language. Highlighting and answering possible questions will be done to complete the educational process. Intervention 2: Intervention group: In the case of pre-hospital emergency personnel, the intervention is in the form of retraining regarding the quick and accurate diagnosis of suspected stroke cases, for this purpose, in addition to the FAST tool, the BEFAST tool and the Iranian IRPSS tool aim to improve diagnosis, inform the hospital and announce the code. Stroke will be used to improve the correct and quick referral of the suspected patient and the time from the onset of symptoms to the transfer of the patient to the hospital. The training of pre-hospital emergency personnel will be done face-to-face and in groups in two two-hour interactive sessions using real scenarios. Then, the important points of the training sessions will be reviewed by sending short reminder messages in the WhatsApp group of medical emergencies, and the personnel will share their experience of using new tools with the aim of solving possible ambiguities.</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 If it is done with ethical considerations, there will be no problem.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naeh Soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Shahriar Ave.,Shahindej Town</address>
        <city>Shahindej</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5981719164</zip>
        <telephone>+98 44 4633 2449</telephone>
        <email>nasehsoltani@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naseh Soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Shahriar Ave., Shahindej Town</address>
        <city>Shahindej</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5981719164</zip>
        <telephone>+98 44 4633 2449</telephone>
        <email>nasehsoltani@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a record of blood pressure, diabetes or hyperlipidemia in comprehensive health service centers in the city of Shahindej and the affiliated villages of the selected center
Willingness to participate in study and training session
Access to a smart mobile phone to join the WhatsApp group to continue and repeat the training
In the case of family members, the person who spends the most time with the patient will be chosen
Being 30 years old or older</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having a file as a high-risk patient (hypertension, diabetes, hyperlipidemia)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebellar stroke syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Early detection</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the case of high-risk patients, the intervention is in the form of educational sessions and using slides in the simple and native language of the region as far as the audience can understand, as well as the use of educational animations in humorous language. Highlighting and answering possible questions will be done to complete the educational process.</i_keyword>
      <i_keyword>Intervention group: In the case of pre-hospital emergency personnel, the intervention is in the form of retraining regarding the quick and accurate diagnosis of suspected stroke cases, for this purpose, in addition to the FAST tool, the BEFAST tool and the Iranian IRPSS tool aim to improve diagnosis, inform the hospital and announce the code. Stroke will be used to improve the correct and quick referral of the suspected patient and the time from the onset of symptoms to the transfer of the patient to the hospital. The training of pre-hospital emergency personnel will be done face-to-face and in groups in two two-hour interactive sessions using real scenarios. Then, the important points of the training sessions will be reviewed by sending short reminder messages in the WhatsApp group of medical emergencies, and the personnel will share their experience of using new tools with the aim of solving possible ambiguities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fast identification and diagnosis. Timepoint: The necessary time periods are about 6 months after the intervention to analyze the obtained data. Method of measurement: The desired variable is quick identification and diagnosis, which will be expressed in minutes from the available documentation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Timely referal to the hospital,. Timepoint: After the educational intervention, the data will be gathered and analyzed up to 6 months later. Method of measurement: According to the data extracted from the available documents, the time will be calculated in minutes.</sec_outcome>
      <sec_outcome>Going to hospital by EMS service. Timepoint: After the educational intervention, the data will be gathered and analyzed up to 6 months later. Method of measurement: The ratio of patients admitted with suspected stroke to the hospital through EMS to the total number of patients admitted with suspected stroke.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-09</approval_date>
        <contact_name>Working Group / Ethics Committee in Research Faculty of Nursing and Midwifery and Faculty of Rehabil</contact_name>
        <contact_address>9, Shahriar Ave., Shahindej Town Shahindej West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
