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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 below

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

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

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 more

TRACE 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,210 Total Patients Enrolled

Media Library

Transition Coach Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05570617 — N/A

Transition Coach Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05570617 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial cater to individuals aged 25 and above?

"This trial mandates that applicants are aged between 16 and 17; 81 clinical trials cater to minors while 124 accept older adults."

Answered by AI

Are vacancies still available in this medical trial?

"This trial is actively seeking participants, as indicated on clinicaltrials.gov; the research was first publicized on November 21st 2022 and recently modified on March 16th 2023."

Answered by AI

What is the total number of test subjects included in this research?

"Affirmative. Clinicaltrials.gov data suggests this medical trial is actively recruiting individuals, which started on November 21st 2022 and was last updated March 16th 2023. 106 patients must be enlisted from a single location to complete the study's goals."

Answered by AI

Can I be a part of this experiment?

"Within the age range of 16 to 17, 106 minors with inflammatory bowel disease are eligible for this trial. The selection criteria additionally requires that candidates have juvenile idiopathic arthritis or IBD and can converse fluently in English; access to a phone (or other digital devices) is also mandatory along with availability over 9 months while collecting data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transition to Adulthood Through Coaching and Empowerment

2022. "Transition to Adulthood Through Coaching and Empowerment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05570617.

All > Inflammatory Bowel Disease