Transition to Adulthood Through Coaching and Empowerment

NCT05570617 | Completed

• 1 other identifier: TRACE
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Juvenile Idiopathic Arthritis

Keywords

Transition in care; Empower Youth in their Transition to Adulthood

Outcome Measures

Primary Outcomes (1)

• Feasibility criteria of pilot study assessed through percent enrolment and completion of program

  To determine the proportion of study participants who will attend at least 6 of 8 (80%) sessions of the Transition Coach Intervention aimed at improving self-efficacy and self-management skills. To determine the number of patients that cannot consent because of the English language barrier, speech, language, hearing, or visual disability barriers, or technology barrier. To determine the number of patients who consent from the total eligible patients approached. To determine the number of outcome assessments completely and how many data items are missing from the data collection forms. Finally, to determine the number of participants which are satisfied with the number of appointments and timeline of the Transition Coach Intervention.

  9 months

Secondary Outcomes (8)

• Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Emotions

  9 months

• Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Medications

  9 months

• Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Social Interactions

  9 months

• Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Symptoms

  9 months

• Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Daily Activities

  9 months

Study Arms (2)

Transition Coach Intervention

EXPERIMENTAL

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.

Behavioral: Transition Coach Intervention

Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care- Youth Transition Roadmap

Interventions

Transition Coach Intervention BEHAVIORAL

The Transition Coach Intervention will include 8, 1-hour sessions over 6-months. The transition coach will independently meet one-on-one with each youth using an individualized, patient-centred approach beginning with an introductory session, followed by 5 sessions covering each topic in the Youth Transition Roadmap. These topics include: Self-Advocacy, Medication Management, General Health, Lifestyle Issues and Future Planning related to education and vocation. The clinical psychologist will lead 2 sessions beginning with the Patient Health Questionnaire for Anxiety and Depression as a screening tool. The clinical psychologist will discuss psychological and social well-being in the context of their disease covering personally relevant issues/concerns.

Transition Coach Intervention

Standard of Care- Youth Transition Roadmap BEHAVIORAL

All participants will receive the Youth Transition Roadmap (standard of care) which discusses 5 domains of healthcare transition; Self-Advocacy, Medication Management, General Health, Lifestyle Issues and Future Planning related to education and vocation. This is an informational pamphlet and will not require any additional meetings with the patient beyond their normal healthcare interactions

Standard of Care

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• year-old Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease patients
• can communicate in English
• have access to a phone (or other communication technology such as a laptop),
• are available over the 9-month follow-up period

You may not qualify if:

• \- cannot communicate in English

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 6, 2022
• Study Start: November 21, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 18, 2026

Record last verified: 2025-03

Locations

CA (1)