NCT04216498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 21, 2018

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

May 21, 2018

Last Update Submit

December 31, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Generalised Anxiety

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

    1 day

Secondary Outcomes (6)

  • Depression

    1 day

  • Health-related quality of life

    1 day

  • Social support

    1 day

  • Family functioning

    1 day

  • Prosocial and problem behaviours

    1 day

  • +1 more secondary outcomes

Study Arms (3)

Pre-Transfer Patients aged 10-16 years

Post-Transfer Patients aged 16-25 years

Parents/Guardians of Pre-Transfer Patients

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will be patients aged 10-25 years or parents/guardians of patients aged 10-16 years who have a diagnosis of juvenile idiopathic arthritis.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2018

First Posted

January 2, 2020

Study Start

May 24, 2017

Primary Completion

April 18, 2018

Study Completion

April 18, 2018

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations