NCT03554824

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 uveitis. This study therefore aims 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, 25 adolescents aged 10-16 years, together with a parent/guardian, will participate at Sheffield Children's Hospital and 10 young adults aged 16-25 years will participate at Sheffield Teaching Hospitals. Participants completed 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). Uveitis disease severity was also measured during clinic appointments. A subset of participants will also be asked to take part in a focus group. This study received full ethical approval, and all participants will give their written informed assent or consent before taking part.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

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

January 3, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2018

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

May 21, 2018

Last Update Submit

September 6, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Generalised Anxiety

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

    Day 1, when participants complete the study questionnaire

Secondary Outcomes (6)

  • Depression

    Day 1, when participants complete the study questionnaire

  • Health-related quality of life

    Day 1, when participants complete the study questionnaire

  • Social support

    Day 1, when participants complete the study questionnaire

  • Family functioning

    Day 1, when participants complete the study questionnaire

  • Prosocial and problem behaviours

    Day 1, when participants complete the study questionnaire

  • +1 more secondary outcomes

Study Arms (3)

Pre-Transfer Adolescents aged 10-16 years

Post-Transfer Young Adults aged 16-25 years

Parents/Guardians of Pre-Transfer Patients

Eligibility Criteria

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

The study population will either be uveitis patients aged 10-25 years or parents/guardians of uveitis patients aged 10-16 years.

You may qualify if:

  • Diagnosis of uveitis
  • Uveitis managed by either Sheffield Children's NHS Foundation Trust or Sheffield Teaching Hospitals NHS Foundation Trust
  • Fluent in English

You may not qualify if:

  • No diagnosis of uveitis
  • Uveitis not managed by either Sheffield Children's NHS Foundation Trust or Sheffield Teaching Hospitals NHS Foundation Trust
  • Not fluent in 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

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye 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

June 13, 2018

Study Start

January 3, 2018

Primary Completion

August 14, 2018

Study Completion

August 14, 2018

Last Updated

September 7, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations