- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216498
Psychosocial Outcomes and Transition Readiness in JIA
Describing Relationships Between Psychosocial Outcomes and Readiness for Transition in Adolescent and Young Adult Patients With Juvenile Idiopathic Arthritis - a Pilot Study
It is widely acknowledged that the transition from paediatric to adult health services should be a multidimensional and multidisciplinary process that addresses the medical, psychosocial, and educational needs of adolescents and young adults (AYA). Despite this, there is currently a scarcity of research examining the relationships between psychosocial factors (e.g., anxiety, social support) and transition readiness in AYA with juvenile idiopathic arthritis (JIA). This study therefore aimed to examine the relationships between psychosocial factors and transition readiness in pre-transfer adolescents and post-transfer young adults aged 10-25 years diagnosed with JIA at a single centre.
In total, 40 adolescents aged 10-16 years together with a parent/guardian, will take part at Sheffield Children's Hospital and 40 young adults aged 16-25 years will take part at Sheffield Teaching Hospitals. Participants will be asked to complete a battery of self-report questionnaire measuring psychosocial factors (anxiety/depression, social support, family functioning, health-related quality of life) and transition readiness (transition knowledge and skills, self-efficacy). JIA disease severity was also measured during clinic appointments. This study has received full ethical approval, and all participants will give their written informed assent or consent before taking part.
The results from this research will be important in better understanding which psychosocial factors affect how ready young people with JIA feel to move from paediatric to adult rheumatology services. We hope this research will inform further work to help target psychological interventions in this group of patients.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Sheffield, United Kingdom
- Sheffield Children's NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Patient Inclusion Criteria:
- Aged 10-25 years
- Diagnosis of juvenile idiopathic arthritis (including all ILAR subtypes except 'systemic arthritis' and 'undifferentiated arthritis')
- Juvenile idiopathic arthritis managed by Sheffield Children's Hospital or Sheffield Teaching Hospitals
- Fluent in verbal and written English
Patient Exclusion Criteria:
- Aged <10 years or >25 years
- Diagnosis of juvenile idiopathic arthritis ILAR subtypes 'systemic arthritis' or 'undifferentiated arthritis')
- Diagnosis of uveitis
- Non-fluent in verbal and written English
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Parents/Guardians of Pre-Transfer Patients
|
Pre-Transfer Patients aged 10-16 years
|
Post-Transfer Patients aged 16-25 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generalised Anxiety
Time Frame: 1 day
|
Generalised Anxiety Disorder-7 Questionnaire (Spitzer et al., 2006)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: 1 day
|
Patient Health Questionnaire-9 Questionnaire (Spitzer et al., 1999)
|
1 day
|
Health-related quality of life
Time Frame: 1 day
|
Paediatric Quality of Life Arthritis Module (Varni et al., 2002)
|
1 day
|
Social support
Time Frame: 1 day
|
Bath Adolescent Pain Questionnaire Social Support Subscale (Eccleston et al., 2005)
|
1 day
|
Family functioning
Time Frame: 1 day
|
Bath Adolescent Pain Questionnaire Family Functioning Subscale (Eccleston et al., 2005)
|
1 day
|
Prosocial and problem behaviours
Time Frame: 1 day
|
Strengths and Difficulties Questionnaire (Goodman, 1997)
|
1 day
|
JIA disease severity (JADAS-3)
Time Frame: 1 day
|
JADAS-3 is a composite score of patient VAS score, physician VAS score, active joint count
|
1 day
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCH-2109
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Juvenile Idiopathic Arthritis
-
University of AarhusAarhus University HospitalCompletedPolyarticular Juvenile Rheumatoid Arthritis | Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis, OligoarthritisDenmark
-
Institut National de la Santé Et de la Recherche...CompletedSystemic-Onset Juvenile Idiopathic ArthritisFrance
-
GeneScience Pharmaceuticals Co., Ltd.Not yet recruitingActive Systemic Juvenile Idiopathic ArthritisChina
-
Novartis PharmaceuticalsCompletedSystemic Juvenile Idiopathic Arthritis (SJIA)Italy, Russian Federation, Turkey, Belgium, Spain, Germany, France, Israel, Canada, United States, Hungary, Austria, Brazil, Sweden, Netherlands, Poland
-
Novartis PharmaceuticalsPediatric Rheumatology International Trials OrganizationCompletedSystemic Juvenile Idiopathic Arthritis With Active FlareUnited States, Argentina, Canada, Switzerland, Germany, Israel, South Africa, Belgium, Italy, Spain, France, Brazil, Turkey, Hungary, Poland, Norway, Sweden, Netherlands, Peru
-
University of British ColumbiaUniversity of Manitoba; The Hospital for Sick Children; McGill University Health... and other collaboratorsRecruiting
-
AbbVieCompletedPolyarticular Juvenile Idiopathic Arthritis
-
NovartisCompletedArthritis, Juvenile RheumatoidItaly
-
AbbottCompletedArthritis, Juvenile IdiopathicUnited States, Belgium, Czech Republic, France, Germany, Italy, Slovakia, Spain
-
Assistance Publique - Hôpitaux de ParisRecruitingJuvenile Idiopathic Arthritis (JIA)France