<?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>IRCT20210114050037N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-03</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>the effect of self-care training by distance education on Functional Status and  the quality of life of patients with rheumatoid arthritis referred to Honari clinic  in Jahrom city in 2022</public_title>
      <acronym></acronym>
      <scientific_title>the effect of self-care training by distance education on Functional Status and  the quality of life of patients with rheumatoid arthritis referred to Honari clinic  in Jahrom city in 2022</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64188</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method is simple random. In this way, the researcher registers their names in a list by number among the people who meet the inclusion criteria and are satisfied to participate in the research. Then these people will be assigned to the intervention and control groups of 39 people each group in every other sample manner, Blinding description: In this study, the person who is responsible for completing the questionnaires is not aware of the allocation of patients in the intervention and control groups, and the person who is going to analyze the data is not aware of which patient is in the intervention or control group. In SPSS, the intervention and control groups will be named as groups 1 and 2, so that the analyst is not aware of the intervention and control groups.).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Rheumatoid Arthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After completing the demographic questionnaires, performance status, and quality of life by this group, virtual training in WhatsApp for this group begins. On a certain day of the week for five weeks, an educational video is uploaded to WhatsApp so that patients in the intervention group can watch the video. Then, patients' feedback on the clip played in the WhatsApp group is examined. One month after the completion of the virtual training, the mentioned questionnaires will be completed by the patients again. Intervention 2: Control group:After completing the demographic questionnaires, performance status and quality of life in this group, no intervention is performed for these patients and they are only subject to the routine training of the treating physician. One month after the completion of virtual training in the intervention group, the mentioned questionnaires are completed again by the patients in the control group. In addition, after that, all the broadcast clips for the intervention group will be provided to the patients of the control group.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Asghar Rahmanian Kushkaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahrom, Madar Boulevard, 17th Alley</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7415854139</zip>
        <telephone>+98 71 5433 3628</telephone>
        <email>Lynurse8@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh badiyepeyma</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahrom, at the end of Ostad Motahhari Boulevard</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 71 5434 0405</telephone>
        <email>zbadiyepeyma@jums.ac.ir</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Rheumatoid arthritis with the diagnosis of the treating physician
Age 18-60 years
At least 6 months history of the disease
Be literate
Having a smartphone that has at least WhatsApp software installed and can use it (can only work with WhatsApp software. No need to master the other software)
Aware of time and place, able to understand Persian language, no psychological illnesses according to the file</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking psychotropic drugs
Being employed in the treatment system
Having advanced and malignant diseases such as cancer, chronic kidney disease and advanced heart disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rheumatoid arthritis with rheumatoid factor</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: After completing the demographic questionnaires, performance status, and quality of life by this group, virtual training in WhatsApp for this group begins. On a certain day of the week for five weeks, an educational video is uploaded to WhatsApp so that patients in the intervention group can watch the video. Then, patients' feedback on the clip played in the WhatsApp group is examined. One month after the completion of the virtual training, the mentioned questionnaires will be completed by the patients again.</i_keyword>
      <i_keyword>Control group:After completing the demographic questionnaires, performance status and quality of life in this group, no intervention is performed for these patients and they are only subject to the routine training of the treating physician. One month after the completion of virtual training in the intervention group, the mentioned questionnaires are completed again by the patients in the control group. In addition, after that, all the broadcast clips for the intervention group will be provided to the patients of the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional Status. Timepoint: Determining the average performance status before the intervention using a performance status questionnaire and one month after the intervention. Method of measurement: status functional questionnaire.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Determining the average quality of life before the intervention by quality of life questionnaire for patients with rheumatoid arthritis and one month after the intervention. Method of measurement: Quality of life questionnaire for patients with rheumatoid arthritis.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-19</approval_date>
        <contact_name>Ethics committee of Jahrom University of Medical Sciences</contact_name>
        <contact_address>Ostad Motahhari Boulevard, Jahrom University of Medical Sciences Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
