Juvenile Idiopathic Arthritis Clinical Trial
Official title:
Describing Relationships Between Psychosocial Outcomes and Readiness for Transition in Adolescent and Young Adult Patients With Juvenile Idiopathic Arthritis - a Pilot Study
| NCT number | NCT04216498 |
| Other study ID # | SCH-2109 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 24, 2017 |
| Est. completion date | April 18, 2018 |
| Verified date | December 2019 |
| Source | Sheffield Children's NHS Foundation Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | April 18, 2018 |
| Est. primary completion date | April 18, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years to 25 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Sheffield Children's NHS Foundation Trust | Sheffield |
| Lead Sponsor | Collaborator |
|---|---|
| Sheffield Children's NHS Foundation Trust | Sheffield Teaching Hospitals NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Generalised Anxiety | Generalised Anxiety Disorder-7 Questionnaire (Spitzer et al., 2006) | 1 day | |
| Secondary | Depression | Patient Health Questionnaire-9 Questionnaire (Spitzer et al., 1999) | 1 day | |
| Secondary | Health-related quality of life | Paediatric Quality of Life Arthritis Module (Varni et al., 2002) | 1 day | |
| Secondary | Social support | Bath Adolescent Pain Questionnaire Social Support Subscale (Eccleston et al., 2005) | 1 day | |
| Secondary | Family functioning | Bath Adolescent Pain Questionnaire Family Functioning Subscale (Eccleston et al., 2005) | 1 day | |
| Secondary | Prosocial and problem behaviours | Strengths and Difficulties Questionnaire (Goodman, 1997) | 1 day | |
| Secondary | JIA disease severity (JADAS-3) | JADAS-3 is a composite score of patient VAS score, physician VAS score, active joint count | 1 day |
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