Transition Coaching for Juvenile Arthritis

(TRACE Trial)

Overseen By Michelle Batthish, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Cannot communicate in English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

106 Participants Needed

Trial Summary

What is the purpose of this trial?

Pediatric patients with Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease who are preparing to transition into adult care face many unique challenges, and, to date, there is no comprehensive and implementable model of transition care in Canada or the United States. These patients, in addition to the systemic inflammatory nature of their diseases, are also in a period of immense psycho-social stress due to changes in school structure, employment, and general psycho-social growth. A poorly managed transition can have adverse effects on the quality and experience of care as well as contribute to poor disease outcomes including increased morbidity and even mortality. The goal of this study is to determine the feasibility of using a transition coach intervention to help patients in their transition from pediatric to adult care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Standard of Care- Youth Transition Roadmap, Transition Coach Intervention for juvenile arthritis?

The research highlights the importance of transitional care for adolescents with juvenile idiopathic arthritis (JIA), noting that a structured transition program can improve the quality of life and reduce drop-out rates from care. Although specific outcome data is limited, the implementation of a clinical transition pathway has shown to enhance patient satisfaction and self-management skills. ^{1 2 3 4 5}

How is the Transition Coach Intervention treatment for juvenile arthritis different from other treatments?

The Transition Coach Intervention is unique because it focuses on helping young patients with juvenile arthritis move smoothly from pediatric to adult healthcare, addressing a critical gap in care that often leads to poor outcomes. Unlike traditional treatments that focus solely on managing symptoms, this intervention aims to improve the overall transition process, which is often unsuccessful for about 50% of patients. ^{1 4 5 6 7}

Eligibility Criteria

This trial is for English-speaking 16-17 year olds with Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease who have access to a phone or laptop and can participate over a 9-month period. It aims to help them transition from pediatric to adult healthcare.

Inclusion Criteria

I am 16 or 17 years old with Inflammatory Bowel Disease.

I am 16 or 17 years old with Juvenile Idiopathic Arthritis.

Can communicate in English

Exclusion Criteria

I am unable to communicate in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline questionnaires to gather demographic and health information

1 week

Transition Coach Intervention

Participants in the intervention group meet with a transition coach and clinical psychologist over 6 months

6 months

6 visits with transition coach, 2 visits with psychologist (phone or telemedicine)

Follow-up

Participants are monitored for changes in self-efficacy and satisfaction with the intervention

3 months

Treatment Details

Interventions

• Standard of Care- Youth Transition Roadmap
• Transition Coach Intervention

Trial Overview The study tests if having a 'transition coach' helps these young patients manage their shift into adult care better than the usual methods. The coach will provide guidance tailored to each individual's needs.

Participant Groups

Group I: Transition Coach Intervention Experimental Treatment 1 Intervention

Half (53) of the participants will be randomly allocated to the Transition Coach Intervention arm of the study. Individuals in the Transition Coach Intervention group will receive the current standard of care (receiving the Youth Transition Roadmap) and meet with the transition coach six times and with a clinical psychologist two times over the course of six months. The meetings between the participant and TC/psychologist will occur over the phone or using the Ontario Telemedicine Network or EPIC.

Group II: Standard of Care Active Control 1 Intervention

The other half of participants will only receive the current standard of care is the Youth Transition Roadmap which has been developed by Hamilton Health Sciences and provides patients information about 5 domains of healthcare transition; Self-Advocacy, Medication Management, General Health, Lifestyle Issues and Future Planning related to education and vocation.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Findings from Research

The implementation of a clinical transition pathway for young people with juvenile-onset rheumatic and musculoskeletal diseases significantly reduced the drop-out rate from 35% to just 5.1% in the adult clinic and 1.3% in the dedicated adolescent JIA-clinic, indicating improved patient retention during the transition process.

Young people reported high satisfaction with the transition process, scoring an average of 7.7 and 7.5 on satisfaction scales, and demonstrated strong self-management skills, with self-efficacy scores of 59.7 and 58.2, suggesting they feel confident in managing their condition post-transition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful implementation of a clinical transition pathway for adolescents with juvenile-onset rheumatic and musculoskeletal diseases. Walter, M., Kamphuis, S., van Pelt, P., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

User perspectives of transitional care for adolescents with juvenile idiopathic arthritis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Successful implementation of a clinical transition pathway for adolescents with juvenile-onset rheumatic and musculoskeletal diseases. [2018]

3. England pubmed.ncbi.nlm.nih.gov

The impact of a coordinated transitional care programme on adolescents with juvenile idiopathic arthritis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Transitional care for adolescents with juvenile idiopathic arthritis: a Delphi study. [2016]

5. Italy pubmed.ncbi.nlm.nih.gov

Patients with juvenile idiopathic arthritis become adults: the role of transitional care. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Developing a programme of transitional care for adolescents with juvenile idiopathic arthritis: results of a postal survey. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Rationale, design and baseline data of a mixed methods study examining the clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: the DON'T RETARD project. [2022]