Psychosocial Outcomes and Transition Readiness in Uveitis

September 6, 2018 updated by: Sheffield Children's NHS Foundation Trust

Describing Relationships Between Psychosocial Outcomes and Readiness for Transition in Adolescent and Young Adult Patients With Uveitis - a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sheffield, United Kingdom
        • Sheffield Children's NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pre-Transfer Adolescents aged 10-16 years
Post-Transfer Young Adults aged 16-25 years
Parents/Guardians of Pre-Transfer Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalised Anxiety
Time Frame: Day 1, when participants complete the study questionnaire
Generalised Anxiety Disorder-7 Questionnaire (Spitzer et al., 2006)
Day 1, when participants complete the study questionnaire

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2018

Primary Completion (ACTUAL)

August 14, 2018

Study Completion (ACTUAL)

August 14, 2018

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (ACTUAL)

June 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCH-2174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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