<?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>IRCT20171122037572N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-03</date_registration>
      <primary_sponsor>National Institute for Medical Research Development</primary_sponsor>
      <public_title>Evaluating the effect of real time feedback (real time  alert beep and SMS on a daily basis), gain reward and lose reward for controlling speed level in commercial drivers in order to reduce traffic injuries in Iran; a field randomized trial</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of real time feedback (real time  alert beep and SMS on a daily basis), gain reward and lose reward for controlling speed level in commercial drivers in order to reduce traffic injuries in Iran; a field randomized trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>400</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49395</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Drivers will be randomly assigned to study arms stratified according to vehicle type. We have the list of names of all available drivers and vehicle types. Stratified randomization is achieved by generating a separate block for vehicle type, and subjects are assigned to the appropriate block. After all, subjects have been identified and assigned into blocks, computerized simple randomization is performed within each block to assign subjects to one of the groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: GROUP A (INFORMATION ONLY): Drivers will receive real-time alerts and daily text messages. The alerts will be loud audio beeps by the telematics device when speed exceeds 10% of posted limit. Text messages will provide a summary indicator of time spent speeding in the last day and comparisons with performance of other drivers. Drivers will be able to text back to receive locations of speed violations in the last day. Intervention 2: Intervention group: GROUP B (GAIN OF REWARD): Drivers will receive real-time alerts, daily text messages, and rewards that would increase to a maximum of 100000 Tomans per month based on their daily performance. Intervention 3: Intervention group: GROUP C (LOSS OF REWARD): Drivers will receive real-time alerts, daily text messages, and will be offered 100000 Tomans at the beginning of each month if they maintain a perfect driving record but will see the rewards diminish with poor performance. Intervention 4: Control group(NO INTERVENTION): Drivers will be unobtrusively monitored using telematics devices.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
a part of data related to primary outcome

When:
The access period begins a few months after the publication of the results, depending on the opinion of the Steering  Committee

To whom:
For researchers working in academic, scientific and non-academic institutions who are also engaged in the industry

Conditions:
The use of documents is in any case subject to the permission of the Steering  Committee

Where to obtain:
Dr. Negar Rezaei

How to obtain:
It varies depending on the type of application and the process of the Steering  Committee

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negar Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Second Floor, No.10, Jalal Al-e-Ahmad Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1911713735</zip>
        <telephone>+98 21 8863 1293</telephone>
        <email>rezaei@ncdrc.info</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negar Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Second Floor, No.10, Jalal Al-e-Ahmad Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1911713735</zip>
        <telephone>+98 21 8863 1293</telephone>
        <email>rezaei@ncdrc.info</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All commercial drivers</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having cell phone</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T14.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified injury</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: GROUP A (INFORMATION ONLY): Drivers will receive real-time alerts and daily text messages. The alerts will be loud audio beeps by the telematics device when speed exceeds 10% of posted limit. Text messages will provide a summary indicator of time spent speeding in the last day and comparisons with performance of other drivers. Drivers will be able to text back to receive locations of speed violations in the last day.</i_keyword>
      <i_keyword>Intervention group: GROUP B (GAIN OF REWARD): Drivers will receive real-time alerts, daily text messages, and rewards that would increase to a maximum of 100000 Tomans per month based on their daily performance</i_keyword>
      <i_keyword>Intervention group: GROUP C (LOSS OF REWARD): Drivers will receive real-time alerts, daily text messages, and will be offered 100000 Tomans at the beginning of each month if they maintain a perfect driving record but will see the rewards diminish with poor performance.</i_keyword>
      <i_keyword>Control group(NO INTERVENTION): Drivers will be unobtrusively monitored using telematics devices</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Distance traveled per trip at speeds more than 10% above speed limit as a proportion of total travel on high-speed roads (speed limits &gt; 90 km/h). Timepoint: In time of speed increase by Telematics and GPS. Method of measurement: Telematics.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Proportion of distance traveled at more than 20% above speed limit on high-speed roads. Timepoint: In time of speed increase. Method of measurement: Telematics devices.</sec_outcome>
      <sec_outcome>Number of harsh acceleration/braking events. Timepoint: when harsh acceleration/braking. Method of measurement: Telematics devices.</sec_outcome>
      <sec_outcome>Harsh turns. Timepoint: when harsh turns. Method of measurement: Telematics devices.</sec_outcome>
      <sec_outcome>Crash/near-crash events. Timepoint: whenever crash/near-crash events happens. Method of measurement: Telematics devices.</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>National Institute for Medical Research Development</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>National Institute for Medical Research Development</contact_name>
        <contact_address>#21 , Besat St., Fatemi St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
