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OpenTrials
Completed

NCT Number: NCT06000566

Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Drug Compliance by Morisky Medication Adherence Scale 8 (MMAS-8)

    Time frame: 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

    Time frame: 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)

    Time frame: 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 outcomes

  1. Descriptice characteristics outcome measure

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yesfa Sebnem Ozbay

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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