<?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>IRCT20210515051303N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-17</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Patient Education Through Social Media on COVID-19-Related Fear, Anxiety, and Self-care in Diabetes Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Patient Education Through Social Media on COVID-19-Related Fear, Anxiety, and Self-care in Diabetes Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56298</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization will be used to assign patients to the control and intervention groups, so that 6 blocks with size of 4 will be used in this regard. The letter A and B will be considered for sampling patients in the intervention and the control group, respectively. The following blocks will be written on pieces of paper with numbers from 1 to 6. We will then randomly pick up the pieces of paper through rolling a dice. Sampling will then begin according to the order achieved in the above procedures.
1. AABB
2. BBAA
3. ABBA
4. BAAB
5. ABAB
6. BABA
According to the order of the letters in the blocks, patients will be assigned to the intervention or control group. Then the next blocks will be selected through rolling the dice again. For example, we roll the dice 6 times for the first time and the following numbers are given by chance:
514362 → ABAB AABB BAAB ABBA BABA BBAA, Blinding description: In this study, participants will not be informed of their allocation to the intervention or control group.
Clinical caregivers and statistical analyzers will also not be aware of patient allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19-related fear, anxiety, and self-care in diabetes patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Training will be provided to the patients in the intervention group during two weeks. On each day of this period, content of an educational topic will be uploaded in specified order for the patients in the intervention group using whatsapp messenger in file formats including audio, photo or video. To ensure the receipt of training by the patients in the intervention group, the researcher will give them a call during the intervention period. Training content includes data on the COVID-19 nature, causes, symptoms, disease transmission, medication, diet, how to quarantine the patient and family, how to observe hygiene, principles of hand washing and personal hygiene, how to dilute and use disinfectants for frequently touched surfaces and used areas, such as bathrooms and toilets. Intervention 2: Control group: Patients in this group will not provided with any intervention so that they only received 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After the completion of the study, researchers will publish the required information based on the ethical considerations in the text of the thesis. Therefore, the required demographic information as well as the mean scores of the dependent variables will be published in the thesis and the article or articles derived fromthis research project.

When:
The thesis resulting from this research project will probably be available in late August 2021. The researchers can access the text of the thesis in the dissertation database of the central library of Zanjan University of Medical Sciences. The article resulting from this thesis will be submitted in one of the prestigious international journals within 6 months after the approval of the thesis.

To whom:
Data and documentation will be available to medical researchers.

Conditions:
The data can be used to study, give citation, create new ideas, and practically apply in medical centers.

Where to obtain:
To receive the data, the researchers can refer to the thesis database of the central library of Zanjan University of Medical Sciences or send an email to the first author of the project (Ali Sadeghian).
Email: alisadeghian75@yahoo.com

How to obtain:
Researchers can get access to the data by providing reasons and guaranteeing citation to the article(s) resulting from the thesis project. They should send an email to the first author of the research project (Ali Sadeghian).
Email: alisadeghian75@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Zirak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Sabouti Blvd., Zanjan University of Medical Sciences, Zanjan School of Nursing and Midwifery</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956113</zip>
        <telephone>+98 24 3314 8318</telephone>
        <email>mohammadzirak@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Zirak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Sabouti Blvd., Zanjan University of Medical Sciences, Zanjan School of Nursing and Midwifery</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956113</zip>
        <telephone>+98 24 3314 8318</telephone>
        <email>mohammadzirak@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>exact diagnosis of diabetes by a physician according to laboratory and clinical tests
Being literate
Having the ability to use a smartphone, tablet,or laptop
Not being infected by COVID-19
Granting written informed consent to participate in the study
Being in the age range of 18-60 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a mental health disorder (Panic disorders, Major depressive disorder, Post traumatic stress disorder)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Training will be provided to the patients in the intervention group during two weeks. On each day of this period, content of an educational topic will be uploaded in specified order for the patients in the intervention group using whatsapp messenger in file formats including audio, photo or video. To ensure the receipt of training by the patients in the intervention group, the researcher will give them a call during the intervention period. Training content includes data on the COVID-19 nature, causes, symptoms, disease transmission, medication, diet, how to quarantine the patient and family, how to observe hygiene, principles of hand washing and personal hygiene, how to dilute and use disinfectants for frequently touched surfaces and used areas, such as bathrooms and toilets.</i_keyword>
      <i_keyword>Control group: Patients in this group will not provided with any intervention so that they only received routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>COVID-19-related fear, anxiety, and self-care. Timepoint: before and immediately after the intervention. Method of measurement: Fear of COVID-19 Scale (FC-19S), COVID-19 Anxiety scale (CDAS), and Self-care in COVID-19 Scale (SCOVID).</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-04</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences, Dr.Sobouti Blvd. Zanjan,Iran Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
