Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychosocial Outcomes and Transition Readiness in JIA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216498
Recruitment Status : Completed
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
Sheffield Teaching Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Sheffield Children's NHS Foundation Trust

Brief 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 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.


Condition or disease
Juvenile Idiopathic Arthritis

Layout table for study information
Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Describing Relationships Between Psychosocial Outcomes and Readiness for Transition in Adolescent and Young Adult Patients With Juvenile Idiopathic Arthritis - a Pilot Study
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : April 18, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Generalised Anxiety [ Time Frame: 1 day ]
    Generalised Anxiety Disorder-7 Questionnaire (Spitzer et al., 2006)


Secondary Outcome Measures :
  1. Depression [ Time Frame: 1 day ]
    Patient Health Questionnaire-9 Questionnaire (Spitzer et al., 1999)

  2. Health-related quality of life [ Time Frame: 1 day ]
    Paediatric Quality of Life Arthritis Module (Varni et al., 2002)

  3. Social support [ Time Frame: 1 day ]
    Bath Adolescent Pain Questionnaire Social Support Subscale (Eccleston et al., 2005)

  4. Family functioning [ Time Frame: 1 day ]
    Bath Adolescent Pain Questionnaire Family Functioning Subscale (Eccleston et al., 2005)

  5. Prosocial and problem behaviours [ Time Frame: 1 day ]
    Strengths and Difficulties Questionnaire (Goodman, 1997)

  6. JIA disease severity (JADAS-3) [ Time Frame: 1 day ]
    JADAS-3 is a composite score of patient VAS score, physician VAS score, active joint count



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216498


Locations
Layout table for location information
United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, United Kingdom
Sponsors and Collaborators
Sheffield Children's NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Layout table for additonal information
Responsible Party: Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04216498    
Other Study ID Numbers: SCH-2109
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases