Juvenile Idiopathic ArthritisNCT04216498
Psychosocial Outcomes and Transition Readiness in JIA
An observational study of Juvenile Idiopathic Arthritis, 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
- Juvenile Idiopathic Arthritis
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2017to 18 Apr 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
- No healthy volunteers
- Child, Adult
Study population: The study population will be patients aged 10-25 years or parents/guardians of patients aged 10-16 years who have a diagnosis of juvenile idiopathic arthritis.
Patient Inclusion Criteria:
- Aged 10-25 years
- Diagnosis of juvenile idiopathic arthritis (including all ILAR subtypes except 'systemic arthritis' and 'undifferentiated arthritis')
- Juvenile idiopathic arthritis managed by Sheffield Children's Hospital or Sheffield Teaching Hospitals
- Fluent in verbal and written English
Patient Exclusion Criteria:
- Aged <10 years or >25 years
- Diagnosis of juvenile idiopathic arthritis ILAR subtypes 'systemic arthritis' or 'undifferentiated arthritis')
- Diagnosis of uveitis
- Non-fluent in verbal and written 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 Juvenile Idiopathic Arthritis - 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 juvenile idiopathic arthritis (JIA). This study therefore aimed 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, 40 adolescents aged 10-16 years together with a parent/guardian, will take part at Sheffield Children's Hospital and 40 young adults aged 16-25 years will take part at Sheffield Teaching Hospitals. Participants will be asked to complete 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). JIA disease severity was also measured during clinic appointments. This study has received full ethical approval, and all participants will give their written informed assent or consent before taking part.
The results from this research will be important in better understanding which psychosocial factors affect how ready young people with JIA feel to move from paediatric to adult rheumatology services. We hope this research will inform further work to help target psychological interventions in this group of patients.
- Conditions
- Juvenile Idiopathic Arthritis
- Medical subject headings
- Arthritis, Juvenile
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 Patients aged 10-16 years | Not described | |
| Post-Transfer Patients 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: 1 day
Secondary outcomes (6)
Depression
Patient Health Questionnaire-9 Questionnaire (Spitzer et al., 1999)
Measured: 1 day
Health-related quality of life
Paediatric Quality of Life Arthritis Module (Varni et al., 2002)
Measured: 1 day
Social support
Bath Adolescent Pain Questionnaire Social Support Subscale (Eccleston et al., 2005)
Measured: 1 day
Family functioning
Bath Adolescent Pain Questionnaire Family Functioning Subscale (Eccleston et al., 2005)
Measured: 1 day
Prosocial and problem behaviours
Strengths and Difficulties Questionnaire (Goodman, 1997)
Measured: 1 day
JIA disease severity (JADAS-3)
JADAS-3 is a composite score of patient VAS score, physician VAS score, active joint count
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start24 May 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies 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
- 120 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
- NCT04216498
- Sponsor's protocol ID
- SCH-2109
- Status last verified
- Dec 2019
- First submitted
- 21 May 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. 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 Juvenile Idiopathic Arthritis - a Pilot Study
- ClinicalTrials.gov ID
- NCT04216498
- Acronym / sponsor ID
- SCH-2109
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 24 May 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 2 Jan 2020 (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 juvenile idiopathic arthritis (JIA). This study therefore aimed 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, 40 adolescents aged 10-16 years together with a parent/guardian, will take part at Sheffield Children's Hospital and 40 young adults aged 16-25 years will take part at Sheffield Teaching Hospitals. Participants will be asked to complete 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). JIA disease severity was also measured during clinic appointments. This study has received full ethical approval, and all participants will give their written informed assent or consent before taking part.
The results from this research will be important in better understanding which psychosocial factors affect how ready young people with JIA feel to move from paediatric to adult rheumatology services. We hope this research will inform further work to help target psychological interventions in this group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Transfer Patients aged 10-16 years | – | – |
| Post-Transfer Patients aged 16-25 years | – | – |
| Parents/Guardians of Pre-Transfer Patients | – | – |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will be patients aged 10-25 years or parents/guardians of patients aged 10-16 years who have a diagnosis of juvenile idiopathic arthritis.
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: 1 day
Generalised Anxiety Disorder-7 Questionnaire (Spitzer et al., 2006)
6 secondary outcomes
Depression
Time frame: 1 day
Health-related quality of life
Time frame: 1 day
Social support
Time frame: 1 day
Family functioning
Time frame: 1 day
Prosocial and problem behaviours
Time frame: 1 day
JIA disease severity (JADAS-3)
Time frame: 1 day
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 2 Jan 2020.
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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 Juvenile Idiopathic Arthritis, 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?
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 2 Jan 2020. 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: 1 day). 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 2 Jan 2020.