Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis

Sponsor
Yesfa Sebnem Ozbay (Other)
Overall Status
Recruiting
CT.gov ID
NCT06000566
Collaborator
(none)
250
1
10
25

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis
    Actual Study Start Date :
    Dec 1, 2022
    Actual Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Pediatric JIA patients

    No interventions will be administered

    Outcome Measures

    Primary Outcome Measures

    1. Drug Compliance by Morisky Medication Adherence Scale 8 (MMAS-8) [November 2022 - August 2023]

      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.

    2. Disease activation score [November 2022 - August 2023]

      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

    3. PedsQL (Pediatric Quality of Life Inventory) [November 2022 - August 2023]

      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.

    Secondary Outcome Measures

    1. Descriptice characteristics outcome measure [November 2022 - May 2023]

      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.

    2. Details of medication [November 2022 - May 2023]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Being followed up with the diagnosis of Juvenile Idiopathic Artritis (JIA) from the pediatric rheumatology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine
    Exclusion Criteria:
    • Refusal of patients or their parents to participate in the study

    • Although the patient is followed up with the diagnosis of JIA, not using medication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University Istanbul Fatih Turkey

    Sponsors and Collaborators

    • Yesfa Sebnem Ozbay

    Investigators

    • Study Chair: Nuray Aktay Ayaz, M.D, M.Sci, Prof, IstabulU

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yesfa Sebnem Ozbay, M.D., Assistant Professor, Principal investigator, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT06000566
    Other Study ID Numbers:
    • Sponsor-Investigator
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 21, 2023