Arthritis, Juvenile RheumatoidNCT06000566
Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis
An observational study of Arthritis, Juvenile Rheumatoid and Medication Adherence, run by Yesfa Sebnem Ozbay at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Arthritis, Juvenile Rheumatoid, Medication Adherence, Quality of Life
- How many people
- 174 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric group of age (0 to 18 years), all patients diagnosed with JIA, all patients are using drugs for their diagnose
Who may be able to join
- Being followed up with the diagnosis of Juvenile Idiopathic Artritis (JIA) from the pediatric rheumatology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
- Medical subject headings
- Arthritis, Juvenile, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric JIA patients | No interventions will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: November 2022 - August 2023
Secondary outcomes (2)
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.
Measured: 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.
Measured: November 2022 - May 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Dec 2022
- Primary completion1 Aug 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, Juvenile RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yesfa Sebnem Ozbay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yesfa Sebnem Ozbay, Istanbul University
- Investigators
- Nuray Aktay Ayaz, M.D, M.Sci, Prof, Study chair, IstabulU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000566
- Sponsor's protocol ID
- Sponsor-Investigator
- Status last verified
- May 2024
- First submitted
- 12 Jun 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT06000566
- Acronym / sponsor ID
- Sponsor-Investigator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Yesfa Sebnem OzbayUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric JIA patients | – | –No interventions will be administered |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric group of age (0 to 18 years), all patients diagnosed with JIA, all patients are using drugs for their diagnose
Key inclusion criteria (1 listed)
- Being followed up with the diagnosis of Juvenile Idiopathic Artritis (JIA) from the pediatric rheumatology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
2 secondary outcomes
Descriptice characteristics outcome measure
Time frame: November 2022 - May 2023
Details of medication
Time frame: November 2022 - May 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuray Aktay Ayaz, M.D, M.Sci, Prof study chair
IstabulU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Juvenile Rheumatoid and Medication Adherence, run by Yesfa Sebnem Ozbay at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Compliance by Morisky Medication Adherence Scale 8 (MMAS-8) (time frame: November 2022 - August 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.