<?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>IRCT20210131050192N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-14</date_registration>
      <primary_sponsor>Saudi Electronic University</primary_sponsor>
      <public_title>Digital-Based Education on students' knowledge and self-protective behaviors</public_title>
      <acronym></acronym>
      <scientific_title>COVID-19 Pandemic: Effect of Digital-Based Educational Intervention Using Protection Motivation Theory on Saudi Electronic University students' knowledge and self-protective behaviors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58004</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Corona Virus infection.</hc_freetext>
      <i_freetext>Intervention 1: For the intervention group: the educational intervention will be designed and carried out based on PMT through four sequential phases: - Needs assessment Phase: it assessed the students' knowledge, self-protection behaviors, and protection motivation factors during COVID-19 pandemic through using the developed tool as a pre-test. Planning phase: based on the results of needs assessment phase, and in the light of the relevant literature, the investigators designed a digital educational intervention based on PMT then it will be independently evaluated by external peer reviewers. The educational intervention aimed to enhance their COVID-19 related knowledge and foster their positive attitude and beliefs about its preventive behaviors. Students’ emails and phone numbers were collected to develop WhatsApp group for the intervention group to facilitate communication. Implementation phase: after program designing and approval, PowerPoint presentation will be sent for the students through their emails. A key health message about COVID-19 will be sent for them through WhatsApp on daily basis to maintain contact and boost their self-efficacy and intention for self-protection. A real-time availability of the investigators through Zoom cloud meeting room will be done on weekly basis to answer students’ questions and correct any misinformation for those in need.  Evaluation phase: follow up will be conducted after 2 months using the same pre-test tools. Intervention 2: For the control group: an online pre-test will be done and repeated two months later, using the same pretest tools (Part II, III, IV). On an ethical basis, the PowerPoint presentation will be given for the control group after the study completion.</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:
published research report that contains all the findings

When:
within one year and will be available log life

To whom:
for public

Conditions:
for scientific use and public education

Where to obtain:
it will be published in scientific journal

How to obtain:
none

Comments:
none</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samiha Hamdi Said</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8 ElRian street , Eldamam KSA</address>
        <city>Eldamam</city>
        <country1>Saudi Arabia</country1>
        <zip>31454</zip>
        <telephone>+966 13 892 7444</telephone>
        <email>s.ramadan@seu.edu.sa</email>
        <affiliation>Saudi Electronic University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samiha Hamdi Said</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8 ElRian street , Eldamam KSA</address>
        <city>Eldamam</city>
        <country1>Saudi Arabia</country1>
        <zip>31454</zip>
        <telephone>+966 13 892 7444</telephone>
        <email>s.ramadan@seu.edu.sa</email>
        <affiliation>Saudi Electronic University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Saudi Arabia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Students who were enrolled in SEU
Willing to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Those who previously participated in any educational program about COVID-19 were excluded from the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus infection, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For the intervention group: the educational intervention will be designed and carried out based on PMT through four sequential phases: - Needs assessment Phase: it assessed the students' knowledge, self-protection behaviors, and protection motivation factors during COVID-19 pandemic through using the developed tool as a pre-test. Planning phase: based on the results of needs assessment phase, and in the light of the relevant literature, the investigators designed a digital educational intervention based on PMT then it will be independently evaluated by external peer reviewers. The educational intervention aimed to enhance their COVID-19 related knowledge and foster their positive attitude and beliefs about its preventive behaviors. Students’ emails and phone numbers were collected to develop WhatsApp group for the intervention group to facilitate communication. Implementation phase: after program designing and approval, PowerPoint presentation will be sent for the students through their emails. A key health message about COVID-19 will be sent for them through WhatsApp on daily basis to maintain contact and boost their self-efficacy and intention for self-protection. A real-time availability of the investigators through Zoom cloud meeting room will be done on weekly basis to answer students’ questions and correct any misinformation for those in need.  Evaluation phase: follow up will be conducted after 2 months using the same pre-test tools.</i_keyword>
      <i_keyword>For the control group: an online pre-test will be done and repeated two months later, using the same pretest tools (Part II, III, IV). On an ethical basis, the PowerPoint presentation will be given for the control group after the study completion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Students' knowledge  regarding COVID-19. Timepoint: two months post intervention. Method of measurement: Part II: Students’ knowledge regarding COVID-19:  it composed of 24 multiple choices questions. The participants were scored “one” for “yes” answer, and “zero” for “no” or “do not know” answer. The total knowledge score ranged between 0-24 and will be categorized as poor (≤60%), fair (60≤75%) or good (˃75%).</prim_outcome>
      <prim_outcome>Students' self-protective behaviors regarding COVID-19. Timepoint: two months post intervention. Method of measurement: Protection motivation theory scale: it assessed the protection motivation factors regarding COVID-19 pandemic. It composed of 28 items distributed over nine constructs: perceived vulnerability (3 items), perceived severity (3 items), intrinsic reward (3 items), extrinsic reward (3 items), fear (3 items), response efficacy (3 items), self-efficacy (3 items), response cost (3 items) and intention for self-protection (4 items). In each item the participants should choose one of five alternatives: strongly agree= 5, agree =4, indifference =3, disagree =2 and strongly disagree=5. For response cost items, scoring will be reversed. The higher score indicates higher self-protection.</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>Saudi Electronic University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-05</approval_date>
        <contact_name>Saudi Electronic University ethical committee</contact_name>
        <contact_address>8 ElRian street , Eldamam KSA Eldamam Eldamam Saudi Arabia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
