Psychosocial Outcomes and Transition Readiness in JIA

Sponsor
Sheffield Children's NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT04216498
Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust (Other)
120
1
10.8
11.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Describing Relationships Between Psychosocial Outcomes and Readiness for Transition in Adolescent and Young Adult Patients With Juvenile Idiopathic Arthritis - a Pilot Study
    Actual Study Start Date :
    May 24, 2017
    Actual Primary Completion Date :
    Apr 18, 2018
    Actual Study Completion Date :
    Apr 18, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Pre-Transfer Patients aged 10-16 years

    Post-Transfer Patients aged 16-25 years

    Parents/Guardians of Pre-Transfer Patients

    Outcome Measures

    Primary Outcome Measures

    1. Generalised Anxiety [1 day]

      Generalised Anxiety Disorder-7 Questionnaire (Spitzer et al., 2006)

    Secondary Outcome Measures

    1. Depression [1 day]

      Patient Health Questionnaire-9 Questionnaire (Spitzer et al., 1999)

    2. Health-related quality of life [1 day]

      Paediatric Quality of Life Arthritis Module (Varni et al., 2002)

    3. Social support [1 day]

      Bath Adolescent Pain Questionnaire Social Support Subscale (Eccleston et al., 2005)

    4. Family functioning [1 day]

      Bath Adolescent Pain Questionnaire Family Functioning Subscale (Eccleston et al., 2005)

    5. Prosocial and problem behaviours [1 day]

      Strengths and Difficulties Questionnaire (Goodman, 1997)

    6. JIA disease severity (JADAS-3) [1 day]

      JADAS-3 is a composite score of patient VAS score, physician VAS score, active joint count

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheffield Children's NHS Foundation Trust Sheffield United Kingdom

    Sponsors and Collaborators

    • Sheffield Children's NHS Foundation Trust
    • Sheffield Teaching Hospitals NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheffield Children's NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT04216498
    Other Study ID Numbers:
    • SCH-2109
    First Posted:
    Jan 2, 2020
    Last Update Posted:
    Jan 2, 2020
    Last Verified:
    Dec 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 2, 2020