xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06000566</url>
    </required_header>
    <id_info>
      <org_study_id>Sponsor-Investigator</org_study_id>
      <nct_id>NCT06000566</nct_id>
    </id_info>
    <brief_title>Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis</brief_title>
    <official_title>Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yesfa Sebnem Ozbay</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn about the drug compliance of patients with&#xD;
        juvenile idiopathic arthritis and, to figure our factors that affect the compliance.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Medication use and compliance in children with chronic diseases is an important problem,&#xD;
             but do patients with JIA really use their medications in harmony?&#xD;
  &#xD;
          -  Does the level of adherence to medications affect the quality of life of patients with&#xD;
             JIA?&#xD;
  &#xD;
        Participants will be asked to fill the demographic form which includes personal information&#xD;
        and nutritional habbits, Morisky Drug Compliance Scale - 8 and the pediatric quality of life&#xD;
        inventory forms, with attending researcher Yesfa Sebnem Ozbay, M.D.&#xD;
  &#xD;
        This study is not an interventional study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Actual">August 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Drug Compliance by Morisky Medication Adherence Scale 8 (MMAS-8)</measure>
      <time_frame>November 2022 - August 2023</time_frame>
      <description>Drug adherence is a hot topic and a big issue among children and adolescents. Drug adherence among chronically ill pediatric patients will be evaluated with Morisky Medication Adherence Scale 8. With a sum of scores equalling 8, 6 to &lt;8, or &lt;6, patients can be categorized as having high, medium or low adherence to therapy, respectively.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Disease activation score</measure>
      <time_frame>November 2022 - August 2023</time_frame>
      <description>The activation score of the disease which will be measured by JADAS. This will help to understand the severity of the disease. JADAS consists of four items; the joint count, the physician and the patient's/parent's global assessment and the erythrocyte sedimentation rate (ESR) as an inflammatory marker. C-reactive protein (CRP) has been suggested as an alternative inflammatory marker. A higher JADAS score indicates higher disease activity as a lower JADAS score indicates lower disease activity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PedsQL (Pediatric Quality of Life Inventory)</measure>
      <time_frame>November 2022 - August 2023</time_frame>
      <description>The quality of life will be evaluated by Pediatric Quality of Life Inventory (PedsQL). Items in PedsQL are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better quality of live.&#xD;
  It is aimed to evaluate the quality of life scores of juvenile idiopathic arthritis patients.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Descriptice characteristics outcome measure</measure>
      <time_frame>November 2022 - May 2023</time_frame>
      <description>The correlation between the education level of the patients, nutritional habits of the patients, the socio-cultural status of the families and drug compliance is also evaluated for each patient.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Details of medication</measure>
      <time_frame>November 2022 - May 2023</time_frame>
      <description>The number of drugs used and the number of swintches between drugs will be evaluated in detail and these data will be evaluated in terms of drug compliance.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Arthritis, Juvenile Rheumatoid</condition>
    <condition>Medication Adherence</condition>
    <condition>Quality of Life</condition>
    <arm_group>
      <arm_group_label>Pediatric JIA patients</arm_group_label>
      <description>No interventions will be administered</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric group of age (0 to 18 years), all patients diagnosed with JIA, all patients are&#xD;
          using drugs for their diagnose&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being followed up with the diagnosis of Juvenile Idiopathic Artritis (JIA) from the&#xD;
               pediatric rheumatology outpatient clinic of Istanbul University, Istanbul Faculty of&#xD;
               Medicine&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of patients or their parents to participate in the study&#xD;
  &#xD;
            -  Although the patient is followed up with the diagnosis of JIA, not using medication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nuray Aktay Ayaz, M.D, M.Sci, Prof</last_name>
      <role>Study Chair</role>
      <affiliation>IstabulU</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yesfa Sebnem Ozbay, M.D.</last_name>
      <phone>+905359759789</phone>
      <email>yesfa.aydin@istanbul.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istanbul University</name>
        <address>
          <city>Istanbul</city>
          <state>Fatih</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nuray Aktay Ayaz, M.D., M.Sci, Prof</last_name>
        <phone>+905326212214</phone>
        <email>nurayaktay@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University</investigator_affiliation>
      <investigator_full_name>Yesfa Sebnem Ozbay</investigator_full_name>
      <investigator_title>M.D., Assistant Professor, Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Juvenile</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06000566
  org study id: Sponsor-Investigator
  nct id: NCT06000566
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the drug compliance of patients with
        juvenile idiopathic arthritis and, to figure our factors that affect the compliance.
  
        The main questions it aims to answer are:
  
          -  Medication use and compliance in children with chronic diseases is an important problem,
             but do patients with JIA really use their medications in harmony?
  
          -  Does the level of adherence to medications affect the quality of life of patients with
             JIA?
  
        Participants will be asked to fill the demographic form which includes personal information
        and nutritional habbits, Morisky Drug Compliance Scale - 8 and the pediatric quality of life
        inventory forms, with attending researcher Yesfa Sebnem Ozbay, M.D.
  
        This study is not an interventional study.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Drug Compliance by Morisky Medication Adherence Scale 8 (MMAS-8)
  time frame: November 2022 - August 2023
  description: Drug adherence is a hot topic and a big issue among children and adolescents. Drug adherence among chronically ill pediatric patients will be evaluated with Morisky Medication Adherence Scale 8. With a sum of scores equalling 8, 6 to <8, or <6, patients can be categorized as having high, medium or low adherence to therapy, respectively.
  measure: Disease activation score
  time frame: November 2022 - August 2023
  description: The activation score of the disease which will be measured by JADAS. This will help to understand the severity of the disease. JADAS consists of four items; the joint count, the physician and the patient's/parent's global assessment and the erythrocyte sedimentation rate (ESR) as an inflammatory marker. C-reactive protein (CRP) has been suggested as an alternative inflammatory marker. A higher JADAS score indicates higher disease activity as a lower JADAS score indicates lower disease activity
  measure: PedsQL (Pediatric Quality of Life Inventory)
  time frame: November 2022 - August 2023
  description: The quality of life will be evaluated by Pediatric Quality of Life Inventory (PedsQL). Items in PedsQL are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better quality of live.
  It is aimed to evaluate the quality of life scores of juvenile idiopathic arthritis patients.
  measure: Descriptice characteristics outcome measure
  time frame: November 2022 - May 2023
  description: The correlation between the education level of the patients, nutritional habits of the patients, the socio-cultural status of the families and drug compliance is also evaluated for each patient.
  measure: Details of medication
  time frame: November 2022 - May 2023
  description: The number of drugs used and the number of swintches between drugs will be evaluated in detail and these data will be evaluated in terms of drug compliance.
  arm group label: Pediatric JIA patients
  description: No interventions will be administered
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 18 Years
  healthy volunteers: No
  last name: Nuray Aktay Ayaz, M.D, M.Sci, Prof
  role: Study Chair
  affiliation: IstabulU
  last name: Yesfa Sebnem Ozbay, M.D.
  phone: +905359759789
  email: yesfa.aydin@istanbul.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Istanbul University
  investigator full name: Yesfa Sebnem Ozbay
  investigator title: M.D., Assistant Professor, Principal investigator
  mesh term: Arthritis
  mesh term: Arthritis, Juvenile