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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Medication Adherence; Arthritis, Juvenile Rheumatoid

• Study Type: Observational
• Enrollment (Actual): 174

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey
      • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric group of age (0 to 18 years), all patients diagnosed with JIA, all patients are using drugs for their diagnose

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pediatric JIA patients; No interventions will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Compliance by Morisky Medication Adherence Scale 8 (MMAS-8)	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.	November 2022 - August 2023
Disease activation score	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	November 2022 - August 2023
PedsQL (Pediatric Quality of Life Inventory)	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.	November 2022 - August 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptice characteristics outcome measure	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.	November 2022 - May 2023
Details of medication	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.	November 2022 - May 2023

Collaborators and Investigators

• Sponsor: Yesfa Sebnem Ozbay
• Investigators: Study Chair: Nuray Aktay Ayaz, M.D, M.Sci, Prof, IstabulU

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: Sponsor-Investigator (Other Identifier: Agustín Velázquez Córdoba)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No