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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a transition coach can assist teens with Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease as they move from pediatric to adult healthcare. The focus is on reducing the stress and challenges during this change, which is crucial because a smooth transition can improve health outcomes. Participants in the experimental group will meet with a transition coach and psychologist through phone calls or online sessions, while the other group will receive standard care resources (Youth Transition Roadmap). Teens who have had one of these conditions for a while and can communicate in English might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could make future transitions smoother for others.

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 prior data suggests that the Transition Coach Intervention is safe for pediatric patients transitioning to adult care?

Research has shown that a transition coach for young people with juvenile idiopathic arthritis (JIA) or inflammatory bowel disease (IBD) is generally well-received. Studies indicate that patients find this support helpful and reassuring as they move from pediatric to adult care. Feedback from young people in similar programs suggests they feel more supported and less stressed.

Reports have not indicated any negative effects from having a transition coach. This approach emphasizes guidance and support, not medical treatment, so it doesn't carry the same risks as medication or surgery. The goal is to help patients manage their health and life changes more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transition Coach Intervention for juvenile arthritis because it offers a personalized approach to helping young people manage their condition as they move from pediatric to adult healthcare. Unlike the standard of care, which provides a general roadmap for transitioning, this intervention includes regular interactions with a transition coach and a clinical psychologist. These one-on-one sessions are designed to empower patients by focusing on self-advocacy, medication management, and future planning. This tailored support aims to make the transition smoother and more effective, potentially improving long-term health outcomes for these young patients.

What evidence suggests that the Transition Coach Intervention could be effective for juvenile arthritis?

This trial will compare the Transition Coach Intervention with the Standard of Care for young patients with juvenile idiopathic arthritis (JIA). Research has shown that a transition coach can ease the shift from pediatric to adult care. In past studies, young people with JIA who received this support managed their health better and felt more confident about their care. Feedback from these patients indicates they value this assistance, which can reduce stress during this crucial transition. Early results suggest that this support might lead to better health outcomes, including less pain and improved quality of life. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11865105/

Transition-related outcomes among a cohort of patients with ...

This study aims to assess transition outcomes in a group of JIA patients during their passage from pediatric to adult healthcare assistance at a single center.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05570617

NCT05570617 | Transition to Adulthood Through Coaching ...

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 ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2949923225000169

Youth feedback through emotional mapping in the ...

Feedback from the emotional mapping exercise indicates the acceptability of the TRACE study among youth with JIA and IBD.

4.

pediatrics.jmir.org

pediatrics.jmir.org/2025/1/e65826

Digital Interventions for Patients With Juvenile Idiopathic Arthritis

Outcomes included pain, physical activity, health-related quality of life, self-efficacy, and disease-related issues. A total of 2 reviewers ...

5.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0295174

A feasibility study protocol | PLOS One - Research journals

The clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: results of the DON'T RETARD project.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11346723/

Transition to Adulthood through Coaching and ...

The clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: results of the DON'T RETARD project.