- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03554824
Psychosocial Outcomes and Transition Readiness in Uveitis
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sheffield, United Kingdom
- Sheffield Children's NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pre-Transfer Adolescents aged 10-16 years
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Post-Transfer Young Adults aged 16-25 years
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Parents/Guardians of Pre-Transfer Patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Generalised Anxiety
Time Frame: Day 1, when participants complete the study questionnaire
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Generalised Anxiety Disorder-7 Questionnaire (Spitzer et al., 2006)
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Day 1, when participants complete the study questionnaire
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: Day 1, when participants complete the study questionnaire
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Patient Health Questionnaire-9 (Spitzer et al., 1999)
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Day 1, when participants complete the study questionnaire
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Health-related quality of life
Time Frame: Day 1, when participants complete the study questionnaire
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Paediatric Quality of Life Generic Module (Varni et al., 2002)
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Day 1, when participants complete the study questionnaire
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Social support
Time Frame: Day 1, when participants complete the study questionnaire
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Bath Adolescent Pain Questionnaire Social Support Subscale (Eccleston et al., 2005)
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Day 1, when participants complete the study questionnaire
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Family functioning
Time Frame: Day 1, when participants complete the study questionnaire
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Bath Adolescent Pain Questionnaire Family Functioning Subscale (Eccleston et al., 2005)
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Day 1, when participants complete the study questionnaire
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Prosocial and problem behaviours
Time Frame: Day 1, when participants complete the study questionnaire
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Strengths and Difficulties Questionnaire (Goodman, 1997)
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Day 1, when participants complete the study questionnaire
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Uveitis disease severity
Time Frame: Day 1, during hospital clinic appointment
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Standardization of uveitis nomenclature (SUN) scores will be used to assess uveitis disease severity.
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Day 1, during hospital clinic appointment
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Uveitis
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Priovant Therapeutics, Inc.Active, not recruitingNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious Pan UveitisUnited States
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University of NebraskaUnknownPosterior Uveitis | Intermediate Uveitis | Pan-uveitisUnited States
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Stanford UniversitySanten Inc.WithdrawnPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
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CHU de Quebec-Universite LavalCompletedIntermediate Uveitis | Anterior UveitisCanada
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Novartis PharmaceuticalsCompletedNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious PanuveitisUnited States, United Kingdom
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EyePoint Pharmaceuticals, Inc.CompletedPanuveitis | Posterior Uveitis | Intermediate UveitisIndia
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Johns Hopkins UniversityMacuSight, Inc.CompletedPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
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The New York Eye & Ear InfirmaryUnknownPanuveitis | Uveitis | Posterior Uveitis | Anterior UveitisUnited States
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Duke UniversityCompletedPosterior Uveitis | Intermediate UveitisUnited States
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AllerganCompletedPosterior Uveitis | Intermediate UveitisFrance, United Kingdom, United States, Spain, Poland, India, South Africa, Korea, Republic of, Canada, Czech Republic, Australia, Germany, Israel, Switzerland, Portugal, Austria, Brazil, Greece