Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis

Quality of Life Clinical Trial

Official title:

Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06000566
• Other study ID #: Sponsor-Investigator
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Juvenile Rheumatoid
• Medication Adherence
• Quality of Life

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Yesfa Sebnem Ozbay

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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