Juvenile Idiopathic ArthritisTRACENCT05570617
Transition to Adulthood Through Coaching and Empowerment
A study testing Transition Coach Intervention in people with Juvenile Idiopathic Arthritis and Inflammatory Bowel Diseases, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Inflammatory Bowel Diseases
- What is being tested?
- Transition Coach Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 21 Nov 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 16-17-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
Who cannot join
- cannot communicate in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The TRACE Study: TRansition to Adulthood Through Coaching and Empowerment - A Pilot Randomized-Controlled 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.
Read the detailed description
This pilot, feasibility study aims to investigate a new approach to transition from pediatric to adult healthcare for Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease patients.
The study population that will be recruited are 16-17-year-olds with Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease seen in pediatric rheumatology or Gastroenterology clinics.
Upon consent, the patients will be asked by the study coordinator about their preferred method of communication (email or phone). Participants will then be randomly allocated to the Transition Coach Intervention or the control group (standard of care) using the Robust Randomization App using variable permuted block randomization (4 or 6) and a 1:1 allocation ratio. 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. The study coordinator will then invite the patients to complete a baseline study questionnaire on the online REDCap secure platform. This baseline questionnaire will gather information to describe our study population including: age, sex, disease type, age at diagnosis, family history, comorbidities and education stream. The investigators will also collect information regarding 'attitude towards transition' and 'feeling ready' for transition using questionnaire.
Once the patient has given informed consent and baseline demographic data has been collected, patients will be asked to complete the following questionnaires using REDCap: i) PedsQL™ 4.0 Generic Scale (18-25 year-old) to measure physical, emotional, social, and school functioning; ii) Patient Global Assessment, a measure of disease activity; and iii) Patient-Reported Outcomes Measurement Information System (PROMIS®) Self-Efficacy outcomes for Chronic Disease including Self-Efficacy for Managing Daily Activities v1.0, Emotions v1.0, Managing Medications and Treatments v1.0, Social Interactions v1.0, Symptoms v1.0, and Informational Support v2.0.
Individuals in the Transition Coach Intervention group will meet with the transition coach six times and with a clinical psychologist two times over the course of six months. 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.
Upon completing the Transition Coach Intervention, two groups of 4-6 participants each will be randomly selected to participate in an Emotional Mapping exercise to share their experiences/satisfaction with the Transition Coach Intervention. Quality Improvement methods will be employed by Hamilton Health Science's Patient Experience office to yield an Emotional Map to inform modifications to the intervention for a future study
- Being tested
- Transition Coach Intervention, Standard of Care- Youth Transition Roadmap
- Keywords
- Transition in care, Empower Youth in their Transition to Adulthood
- Medical subject headings
- Arthritis, Juvenile, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition Coach InterventionBehavioural
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.
Standard of Care- Youth Transition RoadmapBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard of Care- Youth Transition Roadmap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point. The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
Measured: 9 months
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Medications
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point. The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
Measured: 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
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point. The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
Measured: 9 months
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Symptoms
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point. The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
Measured: 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
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point. The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
Measured: 9 months
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Informational Support
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point. The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
Measured: 9 months
Understand the perspective and experience of youth about the Transition Coach Intervention with a satisfaction questionnaire
Measuring all the participants satisfaction with the Transition Coach Intervention by asking participants to fill in a satisfaction questionnaire asking about the appropriate number of meetings, length of meetings, and the types of topics discussed. The investigators will describe within-person, within-group and between-group changes in satisfaction in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
Measured: 9 months
Understand the perspective and experience of youth about the Transition Coach Intervention with a focus group
Measuring the participants satisfaction with the Transition Coach Intervention by asking participants to join a focus group to do an Emotional Mapping feedback exercise. This will be done by two groups of 5-7 participants (one group of Juvenile Idiopathic Arthritis patients and another of Inflammatory Bowel Disease patients), randomly selected to share their experiences/satisfaction with the Transition Coach Intervention. The responses from the Emotional Mapping exercise will inform modifications to the intervention in the future study.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start21 Nov 2022
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570617
- Sponsor's protocol ID
- TRACE
- Acronym
- TRACE
- Status last verified
- Mar 2025
- First submitted
- 15 Sep 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TRACE Study: TRansition to Adulthood Through Coaching and Empowerment - A Pilot Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT05570617
- Acronym / sponsor ID
- TRACE / TRACE
- Keywords
- Transition in care, Empower Youth in their Transition to Adulthood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot, feasibility study aims to investigate a new approach to transition from pediatric to adult healthcare for Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease patients.
The study population that will be recruited are 16-17-year-olds with Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease seen in pediatric rheumatology or Gastroenterology clinics.
Upon consent, the patients will be asked by the study coordinator about their preferred method of communication (email or phone). Participants will then be randomly allocated to the Transition Coach Intervention or the control group (standard of care) using the Robust Randomization App using variable permuted block randomization (4 or 6) and a 1:1 allocation ratio. 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. The study coordinator will then invite the patients to complete a baseline study questionnaire on the online REDCap secure platform. This baseline questionnaire will gather information to describe our study population including: age, sex, disease type, age at diagnosis, family history, comorbidities and education stream. The investigators will also collect information regarding 'attitude towards transition' and 'feeling ready' for transition using questionnaire.
Once the patient has given informed consent and baseline demographic data has been collected, patients will be asked to complete the following questionnaires using REDCap: i) PedsQL™ 4.0 Generic Scale (18-25 year-old) to measure physical, emotional, social, and school functioning; ii) Patient Global Assessment, a measure of disease activity; and iii) Patient-Reported Outcomes Measurement Information System (PROMIS®) Self-Efficacy outcomes for Chronic Disease including Self-Efficacy for Managing Daily Activities v1.0, Emotions v1.0, Managing Medications and Treatments v1.0, Social Interactions v1.0, Symptoms v1.0, and Informational Support v2.0.
Individuals in the Transition Coach Intervention group will meet with the transition coach six times and with a clinical psychologist two times over the course of six months. 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.
Upon completing the Transition Coach Intervention, two groups of 4-6 participants each will be randomly selected to participate in an Emotional Mapping exercise to share their experiences/satisfaction with the Transition Coach Intervention. Quality Improvement methods will be employed by Hamilton Health Science's Patient Experience office to yield an Emotional Map to inform modifications to the intervention for a future study
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transition Coach Intervention | Experimental | Behavioral: Transition Coach InterventionHalf (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. |
| Standard of Care | Active comparator | Behavioral: Standard of Care- Youth Transition RoadmapThe 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 may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 16-17-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
Key exclusion criteria (1 listed)
- cannot communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition Coach InterventionThe 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. | Behavioural | Transition Coach Intervention |
| Standard of Care- Youth Transition RoadmapAll 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 | Behavioural | Standard of Care |
Primary outcome
Feasibility criteria of pilot study assessed through percent enrolment and completion of program
Time frame: 9 months
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.
8 secondary outcomes
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Emotions
Time frame: 9 months
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Medications
Time frame: 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
Time frame: 9 months
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Symptoms
Time frame: 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
Time frame: 9 months
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Informational Support
Time frame: 9 months
Understand the perspective and experience of youth about the Transition Coach Intervention with a satisfaction questionnaire
Time frame: 9 months
Understand the perspective and experience of youth about the Transition Coach Intervention with a focus group
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 40243391Tiles-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition Coach Intervention in people with Juvenile Idiopathic Arthritis and Inflammatory Bowel Diseases, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility criteria of pilot study assessed through percent enrolment and completion of program (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05570617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.