<?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>IRCT20230405057828N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-23</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of self-care training on rheumatoid arthritis patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effect of Self-care Training Based on Concept mapping on the Quality of Life of Rheumatoid Arthritis Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69503</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>Rheumatoid Arthritis.</hc_freetext>
      <i_freetext>Intervention 1: Control Group: First, a Pre-test will be Taken from the Control group, and a Post-test will be taken a month later, Then Self-care Educational content will be taught Face-to-face Using a CD. The training is done in two sessions, the time of training will be coordinated with the patient and it is maximum in two weeks. Educational content is about disease Recognition, complications, drugs and treatments, physical self-care, sports activities, pain management, performance self-care, health promotion methods, sleep and rest, diet and joint protection principles. Intervention 2: Intervention group: A pre-test will be conducted for the research units in the intervention group, then self-care educational content will be taught face-to-face using CDs and laptops. The training is in the form of a concept map, which shows in the form of a visual diagram. The training is done in two sessions and in the classroom located in the hospital. The training time is coordinated with the patient and is maximum in two weeks. The time of each session is 45 minutes. The educational content is about disease recognition, complications, drugs and treatments, physical self-care, sports activities, pain management, performance self-care, health promotion methods, sleep and rest, diet and joint protection principles. Then, one month after the last training session, the post-test will be conducted. In this research, information will be collected using a three-part questionnaire including a demographic questionnaire, a quality of life questionnaire for rheumatoid arthritis patients, and a pain questionnaire for rheumatoid arthritis patients, which will take 10 minutes to fill out. The validity of the questionnaires will be checked by the relevant professors.</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 Further Information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Navid Dadashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, No. 7, Mitsagh End, Kohistan Blvd, Kitab Square, Saadat Abad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981656183</zip>
        <telephone>+98 936 741 6647</telephone>
        <email>Naviddadashi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Navid Dadashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, No. 7, Mitsagh End, Kohistan Blvd, Kitab Square, Saadat Abad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981656183</zip>
        <telephone>+98 936 741 6647</telephone>
        <email>Naviddadashi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age Between 18 and 60 Years
Being Literate in Reading and Writing
Informed Consent
Definitive Diagnosis of Rheumatoid Arthritis By a Rheumatologist
Ability to Use CD</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering From Other Chronic Diseases
Suffering From Mental Diseases</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control Group: First, a Pre-test will be Taken from the Control group, and a Post-test will be taken a month later, Then Self-care Educational content will be taught Face-to-face Using a CD. The training is done in two sessions, the time of training will be coordinated with the patient and it is maximum in two weeks. Educational content is about disease Recognition, complications, drugs and treatments, physical self-care, sports activities, pain management, performance self-care, health promotion methods, sleep and rest, diet and joint protection principles.</i_keyword>
      <i_keyword>Intervention group: A pre-test will be conducted for the research units in the intervention group, then self-care educational content will be taught face-to-face using CDs and laptops. The training is in the form of a concept map, which shows in the form of a visual diagram. The training is done in two sessions and in the classroom located in the hospital. The training time is coordinated with the patient and is maximum in two weeks. The time of each session is 45 minutes. The educational content is about disease recognition, complications, drugs and treatments, physical self-care, sports activities, pain management, performance self-care, health promotion methods, sleep and rest, diet and joint protection principles. Then, one month after the last training session, the post-test will be conducted. In this research, information will be collected using a three-part questionnaire including a demographic questionnaire, a quality of life questionnaire for rheumatoid arthritis patients, and a pain questionnaire for rheumatoid arthritis patients, which will take 10 minutes to fill out. The validity of the questionnaires will be checked by the relevant professors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life Score in the Quality of Life Questionnaire of Rheumatoid Arthritis Patients. Timepoint: Measuring the Quality of Life at the Beginning of the Study (Before the Start of the Intervention) and one Month After the Last Session of Self-care Training. Method of measurement: Questionnaire of Rheumatoid Arthritis Quality of Life.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain Score of Rheumatoid Arthritis Patients. Timepoint: At the Beginning of the Study (Before the Start of the Intervention) and One Month After the Last Training Session. Method of measurement: Rheumatoid Arthritis Pain Scale Questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-23</approval_date>
        <contact_name>Ethics Committee in Research Faculty of Nursing and Midwifery and Faculty of Rehabilitation - Tehran</contact_name>
        <contact_address>Room 604, Sixth floor, Central building of Tehran University of Medical Sciences, Intersection of Qods St, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
