Juvenile Idiopathic ArthritisTRACERNCT05545839
Transition to Adulthood Through Coaching and Empowerment in Rheumatology
A study testing Transition coaching in people with Juvenile Idiopathic Arthritis and Juvenile Rheumatoid Arthritis, run by McMaster University at 2 sites in Canada.
Trial summary
TRACER is a study aiming to investigate the feasibility of transition coaching sessions for patients moving from paediatric to adult rheumatology care. Read more about this study
- Who is it for?
- Ages 17 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis, Juvenile Dermatomyositis
- What is being tested?
- Transition coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesCanada
- Study dates
- 17 Oct 2022to 31 Dec 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 17 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient with pediatic-onset rheumatic disease
- At their last paediatric rheumatology appointment prior to transferring to adult rheumatology care
- Able to communicate in English
- Have a phone or device capable of participating in video conference
- Available over the next 8 months
Who cannot join
- Cognitive impairment preventing participation in individualized education sessions (as determined by medical staff)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Children's Hospital at London Health Sciences Centre
London, Ontario, N6A 5W9
About this study
Official title: TRACER: Transition to Adulthood Through Coaching and Empowerment in Rheumatology, A Feasibility Study
TRACER is a study aiming to investigate the feasibility of transition coaching sessions for patients moving from paediatric to adult rheumatology care.
Read the detailed description
TRACER is a feasibility study investigating transition coaching for patients with rheumatic disease transferring from paediatric to adult rheumatology care. This is a vulnerable time in the patients' care and life as they are assuming more responsibility for their health and undergoing significant life transitions. There is risk for increased morbidity and mortality around this time if the patient are not well supported and if they do not stay engaged with care. This intervention aim to provide self-efficacy, self-management, coping skills and support to patients making the transition. This study aims to assess the feasibility of conducting a multi-centre randomized trial.
- Conditions
- Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis, Juvenile Dermatomyositis, Juvenile Psoriatic Arthritis, Autoinflammatory Disease, Autoimmune Diseases
- Being tested
- Transition coaching
- Keywords
- transition care, transition coaching
- Medical subject headings
- Arthritis, Juvenile, Dermatomyositis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition coachingBehavioural
Transition coaching sessions (8 sessions), covering paediatric to adult care, self-advocacy, medication management, general health, lifestyle and behaviours, future planning, screening for mood disorders and coping skills.
| Study group | Role | What they receive |
|---|---|---|
| Standard care - control | No intervention | Standard of care, appointments with adult rheumatology |
| Transition coaching - experimental | Experimental | Participants will receive 8 transition coaching sessions (1/month) in addition to standard care Receives: Behavioral: Transition coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
% of patients approached who consent to the study
Measured: 19 month recruitment period
Enrolment from non-primary site
% of patients enrolled from non-primary site
Measured: 19 month
Virtual session attendance
% of transition coaching sessions attended
Measured: 3 year study period
Outcome measure completion
% of outcome assessments completed at 8 months (end of transition coach invention)
Measured: 3 year study period
Missing data
% of missing data
Measured: 3 year study period
Secondary outcomes (4)
Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire
Descriptive statistics of PROMIS questionnaire (person-centered measures to assess how people feel and function) results at baseline, 8 months and 11 months, between the two groups.
Measured: 3 year study period
Physician Global Assessment (PGA)
Descriptive statistics of physical global assessment at baseline and at subsequent follow-up, between the two groups. Physician Global Assessment refers to MD assessment of disease activity and is rated between 0 (no disease activity) and 10 (most active disease).
Measured: 3 year study period
Active joint count
Descriptive statistics of active joint count (joints with evidence of active inflammation - including swelling, tenderness, loss of ROM) at baseline and at subsequent follow-up, between the two groups
Measured: 3 year study period
Global function/quality of life
Descriptive statistics of PedsQL (Paediatric Quality of Life Inventory) 4.0 Generic Core Scales Young Adult Version questionnaire results at baseline, 8 months and 11 months, between the two groups.
Measured: 3 year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start17 Oct 2022
- Primary completion1 May 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Western University
- Responsible party
- Principal investigator, Michelle Batthish, McMaster University
- Investigators
- Michelle Batthish, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545839
- Sponsor's protocol ID
- 14499
- Acronym
- TRACER
- Status last verified
- Feb 2026
- First submitted
- 13 Sep 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRACER: Transition to Adulthood Through Coaching and Empowerment in Rheumatology, A Feasibility Study
- ClinicalTrials.gov ID
- NCT05545839
- Acronym / sponsor ID
- TRACER / 14499
- Conditions
- Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis, Juvenile Dermatomyositis, Juvenile Psoriatic Arthritis, Autoinflammatory Disease, Autoimmune Diseases
- Keywords
- transition care, transition coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Western University
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Sep 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.
TRACER is a study aiming to investigate the feasibility of transition coaching sessions for patients moving from paediatric to adult rheumatology care.
Detailed description
TRACER is a feasibility study investigating transition coaching for patients with rheumatic disease transferring from paediatric to adult rheumatology care. This is a vulnerable time in the patients' care and life as they are assuming more responsibility for their health and undergoing significant life transitions. There is risk for increased morbidity and mortality around this time if the patient are not well supported and if they do not stay engaged with care. This intervention aim to provide self-efficacy, self-management, coping skills and support to patients making the transition. This study aims to assess the feasibility of conducting a multi-centre randomized trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care - control | No intervention | –Standard of care, appointments with adult rheumatology |
| Transition coaching - experimental | Experimental | Behavioral: Transition coachingParticipants will receive 8 transition coaching sessions (1/month) in addition to standard care |
Who may qualify
- Ages
- 17 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patient with pediatic-onset rheumatic disease
- At their last paediatric rheumatology appointment prior to transferring to adult rheumatology care
- Able to communicate in English
- Have a phone or device capable of participating in video conference
- Available over the next 8 months
Key exclusion criteria (1 listed)
- Cognitive impairment preventing participation in individualized education sessions (as determined by medical staff)
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 coachingTransition coaching sessions (8 sessions), covering paediatric to adult care, self-advocacy, medication management, general health, lifestyle and behaviours, future planning, screening for mood disorders and coping skills. | Behavioural | Transition coaching - experimental |
Primary outcome
Consent rate
Time frame: 19 month recruitment period
% of patients approached who consent to the study
Enrolment from non-primary site
Time frame: 19 month
% of patients enrolled from non-primary site
Virtual session attendance
Time frame: 3 year study period
% of transition coaching sessions attended
Outcome measure completion
Time frame: 3 year study period
% of outcome assessments completed at 8 months (end of transition coach invention)
Missing data
Time frame: 3 year study period
% of missing data
4 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire
Time frame: 3 year study period
Physician Global Assessment (PGA)
Time frame: 3 year study period
Active joint count
Time frame: 3 year study period
Global function/quality of life
Time frame: 3 year study period
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 11 Feb 2026.
Related trials for Juvenile Idiopathic Arthritis
RecruitingPhase 3
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Recruiting
The Use of Infrared Cameras for Detecting Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis, Infrared Thermography
Not yet recruitingPhase 4
Withdrawal Versus Continued TNF Inhibitor Monotherapy Treatment in Children With Inactive Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingObservational study
Tofacitinib in Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingPhase 3
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
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.
Michelle Batthish, MD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition coaching in people with Juvenile Idiopathic Arthritis and Juvenile Rheumatoid Arthritis, run by McMaster University at 2 sites 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 5 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Consent rate (time frame: 19 month recruitment period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026.