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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03554824
Other study ID # SCH-2174
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2018
Est. completion date August 14, 2018

Study information

Verified date September 2018
Source Sheffield Children's NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date August 14, 2018
Est. primary completion date August 14, 2018
Accepts healthy volunteers
Gender All
Age group 10 Years to 25 Years
Eligibility Inclusion Criteria:

- Diagnosis of uveitis

- Uveitis managed by either Sheffield Children's NHS Foundation Trust or Sheffield Teaching Hospitals NHS Foundation Trust

- Fluent in English

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Sheffield Children's NHS Foundation Trust Sheffield

Sponsors (2)

Lead Sponsor Collaborator
Sheffield Children's NHS Foundation Trust Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Generalised Anxiety Generalised Anxiety Disorder-7 Questionnaire (Spitzer et al., 2006) Day 1, when participants complete the study questionnaire
Secondary Depression Patient Health Questionnaire-9 (Spitzer et al., 1999) Day 1, when participants complete the study questionnaire
Secondary Health-related quality of life Paediatric Quality of Life Generic Module (Varni et al., 2002) Day 1, when participants complete the study questionnaire
Secondary Social support Bath Adolescent Pain Questionnaire Social Support Subscale (Eccleston et al., 2005) Day 1, when participants complete the study questionnaire
Secondary Family functioning Bath Adolescent Pain Questionnaire Family Functioning Subscale (Eccleston et al., 2005) Day 1, when participants complete the study questionnaire
Secondary Prosocial and problem behaviours Strengths and Difficulties Questionnaire (Goodman, 1997) Day 1, when participants complete the study questionnaire
Secondary Uveitis disease severity Standardization of uveitis nomenclature (SUN) scores will be used to assess uveitis disease severity. Day 1, during hospital clinic appointment
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