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Transition Coaching for Juvenile Arthritis (TRACE Trial)
N/A
Recruiting
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
16-17-year-old Inflammatory Bowel Disease patients
16-17-year-old Juvenile Idiopathic Arthritis patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
TRACE Trial Summary
This trial is looking at helping pediatric patients with Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease transitioning to adult care by using a transition coach intervention to help them navigate the changes in care, school, employment, and psycho-social growth.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves coaching rather than medication, there are no direct medical side effects. However, participants may experience stress or anxiety related to discussing their condition and future care plans.
TRACE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 16 or 17 years old with Inflammatory Bowel Disease.
Select...
I am 16 or 17 years old with Juvenile Idiopathic Arthritis.
TRACE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility criteria of pilot study assessed through percent enrolment and completion of program
Secondary outcome measures
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Informational Support
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Daily Activities
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Emotions
+5 moreTRACE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transition Coach InterventionExperimental Treatment1 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 CareActive Control1 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.
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Who is running the clinical trial?
McMaster UniversityLead Sponsor
891 Previous Clinical Trials
2,605,360 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 16 or 17 years old with Inflammatory Bowel Disease.I am 16 or 17 years old with Juvenile Idiopathic Arthritis.I am unable to communicate in English.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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