UveitisNCT03554824
Psychosocial Outcomes and Transition Readiness in Uveitis
An observational study of Uveitis, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Uveitis
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jan 2018to 14 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- Child, Adult
Study population: The study population will either be uveitis patients aged 10-25 years or parents/guardians of uveitis patients aged 10-16 years.
Who may be able to join
- Diagnosis of uveitis
- Uveitis managed by either Sheffield Children's NHS Foundation Trust or Sheffield Teaching Hospitals NHS Foundation Trust
- Fluent in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield
About this study
Official title: 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.
- Conditions
- Uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Transfer Adolescents aged 10-16 years | Not described | |
| Post-Transfer Young Adults aged 16-25 years | Not described | |
| Parents/Guardians of Pre-Transfer Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalised Anxiety
Generalised Anxiety Disorder-7 Questionnaire (Spitzer et al., 2006)
Measured: Day 1, when participants complete the study questionnaire
Secondary outcomes (6)
Depression
Patient Health Questionnaire-9 (Spitzer et al., 1999)
Measured: Day 1, when participants complete the study questionnaire
Health-related quality of life
Paediatric Quality of Life Generic Module (Varni et al., 2002)
Measured: Day 1, when participants complete the study questionnaire
Social support
Bath Adolescent Pain Questionnaire Social Support Subscale (Eccleston et al., 2005)
Measured: Day 1, when participants complete the study questionnaire
Family functioning
Bath Adolescent Pain Questionnaire Family Functioning Subscale (Eccleston et al., 2005)
Measured: Day 1, when participants complete the study questionnaire
Prosocial and problem behaviours
Strengths and Difficulties Questionnaire (Goodman, 1997)
Measured: Day 1, when participants complete the study questionnaire
Uveitis disease severity
Standardization of uveitis nomenclature (SUN) scores will be used to assess uveitis disease severity.
Measured: Day 1, during hospital clinic appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start3 Jan 2018
- Primary completion14 Aug 2018
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554824
- Sponsor's protocol ID
- SCH-2174
- Status last verified
- Sep 2018
- First submitted
- 21 May 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describing Relationships Between Psychosocial Outcomes and Readiness for Transition in Adolescent and Young Adult Patients With Uveitis - a Pilot Study
- ClinicalTrials.gov ID
- NCT03554824
- Acronym / sponsor ID
- SCH-2174
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Transfer Adolescents aged 10-16 years | – | – |
| Post-Transfer Young Adults aged 16-25 years | – | – |
| Parents/Guardians of Pre-Transfer Patients | – | – |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The study population will either be uveitis patients aged 10-25 years or parents/guardians of uveitis patients aged 10-16 years.
Key inclusion criteria (3 listed)
- Diagnosis of uveitis
- Uveitis managed by either Sheffield Children's NHS Foundation Trust or Sheffield Teaching Hospitals NHS Foundation Trust
- Fluent in English
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Generalised Anxiety
Time frame: Day 1, when participants complete the study questionnaire
Generalised Anxiety Disorder-7 Questionnaire (Spitzer et al., 2006)
6 secondary outcomes
Depression
Time frame: Day 1, when participants complete the study questionnaire
Health-related quality of life
Time frame: Day 1, when participants complete the study questionnaire
Social support
Time frame: Day 1, when participants complete the study questionnaire
Family functioning
Time frame: Day 1, when participants complete the study questionnaire
Prosocial and problem behaviours
Time frame: Day 1, when participants complete the study questionnaire
Uveitis disease severity
Time frame: Day 1, during hospital clinic appointment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalised Anxiety (time frame: Day 1, when participants complete the study questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.