<?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>IRCT20191021045178N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-22</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of supportive intervention in patients with systemic lupus erythematosus</public_title>
      <acronym></acronym>
      <scientific_title>Effect of medical team supportive intervention through social networks on health anxiety and acceptance of disability in patients with systemic lupus erythematosus referred to selected educational and medical centers affiliated to Shiraz University of Medical Sciences-2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52913</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, first, according to the list of patients in the clinic, a list of patients who meet the inclusion criteria is determined. Then sampling will be done by systematic random method. Select the appropriate distance (k) and select the names at equal intervals along the list. The distance or k is obtained by dividing the number of members of the study population by the number of members in the sample. It should be noted that the starting point for this regular selection process is random and is done from a table of random numbers. Finally, 124 people are included in the study as a sample.
Then, using blocking software, 124 people will be randomly placed in blocks A and B. Using this method, the number of people assigned to each block will be equal to 62 people. Finally, by tossing coins, each block will be placed in two groups of control and intervention, Blinding description: In this study, the data collector and the data analyzer are blinded to the grouping of patients into two groups of intervention and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>systemic lupus erythematosus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The members of the intervention group are members of one of the virtual social networks managed by the researcher and the materials that include providing supportive intervention to patients with systemic lupus erythematosus are provided to them through this virtual social network. Virtual supportive intervention will be provided daily for 8 weeks, taking into account various aspects of spiritual, psychological and informational support. Content will be provided on the WhatsApp social network. A WhatsApp channel will be created with the management of the research team. The intervention group will receive text and multimedia messages at 4 time intervals during the day. The maximum number of messages per period is 3 messages. The content is assessed based on the pre-test and it is possible to change the program according to the needs of the participants. Scientific content based on authoritative and up-to-date articles and books on systemic lupus erythematosus as well as the Lupus Patients Support Association will be presented. The content is polled every weekend and it is possible to make changes based on the feedback received. Feedback is obtained through an online questionnaire or by sending participants' comments to the researcher's WhatsApp personal page. In order to emphasize the key content, the main points are placed in the channel again every Thursday. A psychologist colleague is assisted as a researcher in presenting psychological content. According to the needs assessment and request of the participants, the content they need in the field of research policy will be sent to them separately on the WhatsApp personal page. Intervention 2: Control group: They do not receive supportive intervention through social media. They receive care includes routine nursing care and training.</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 After completion of the study, if necessary, the encoded data will be published along with the article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloofar Pasyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, namazi Square, Zand st.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>pasyarn@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nilofar Pasyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Namazi Square, Zand st.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>pasyarn@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of the diagnosis of systemic lupus erythematosus by a physician
Age range over 18 years
Has a mobile phone and is able to use mobile software
Ability to understand and speak Persian language
Do not have acute mental and cognitive disease diagnosed based on the contents of the file
No other known and effective physical disease
The patient has only lupus erythematosus</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having Known and influential physical illness
Having Mental illness
Having Drug-Induced Lupus Erythematosus or Lupus of the Skin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Systemic lupus erythematosus (SLE)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The members of the intervention group are members of one of the virtual social networks managed by the researcher and the materials that include providing supportive intervention to patients with systemic lupus erythematosus are provided to them through this virtual social network. Virtual supportive intervention will be provided daily for 8 weeks, taking into account various aspects of spiritual, psychological and informational support. Content will be provided on the WhatsApp social network. A WhatsApp channel will be created with the management of the research team. The intervention group will receive text and multimedia messages at 4 time intervals during the day. The maximum number of messages per period is 3 messages. The content is assessed based on the pre-test and it is possible to change the program according to the needs of the participants. Scientific content based on authoritative and up-to-date articles and books on systemic lupus erythematosus as well as the Lupus Patients Support Association will be presented. The content is polled every weekend and it is possible to make changes based on the feedback received. Feedback is obtained through an online questionnaire or by sending participants' comments to the researcher's WhatsApp personal page. In order to emphasize the key content, the main points are placed in the channel again every Thursday. A psychologist colleague is assisted as a researcher in presenting psychological content. According to the needs assessment and request of the participants, the content they need in the field of research policy will be sent to them separately on the WhatsApp personal page.</i_keyword>
      <i_keyword>Control group: They do not receive supportive intervention through social media. They receive care includes routine nursing care and training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health anxiety. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Salkowski &amp; Warwick Health Anxiety Questionnaire (2002).</prim_outcome>
      <prim_outcome>Acceptance of disability. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: acceptance of disability questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-07</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, 7th floor, Shiraz University of Medical Science, Zand st. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
