Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis

NCT06000566 | Completed

• 1 other identifier: Sponsor-Investigator
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Juvenile Rheumatoid; Medication Adherence; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Descriptice characteristics outcome measure

  November 2022 - May 2023

• Details of medication

  November 2022 - May 2023

Study Arms (1)

Pediatric JIA patients

No interventions will be administered

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Being followed up with the diagnosis of Juvenile Idiopathic Artritis (JIA) from the pediatric rheumatology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine

You may not qualify if:

• 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

Sponsors & Collaborators

• Yesfa Sebnem Ozbay: lead

Study Sites (1)

Istanbul University

Istanbul, Fatih, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Juvenile; Medication Adherence

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Nuray Aktay Ayaz, M.D, M.Sci, Prof

  IstabulU

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Assistant Professor, Principal investigator

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: August 21, 2023
• Study Start: December 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: March 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

TU (1)