Rheumatic ConditionsTRACERNCT07838896
Transition Coaching in Rheumatology
A study testing transition coaching in people with Rheumatic Conditions, run by McMaster University at 1 site in Canada.
Trial summary
The period leading up to and following transfer from pediatric to adult care for youth with rheumatic disease is a vulnerable time leaving youth at risk of poor self-efficacy (confidence in ability to manage all aspects of their health). Read more about this study
- Who is it for?
- Ages 16 to 18 years
- Conditions the study is for
- Rheumatic Conditions
- 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
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2027to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- will be transferred to adult rheumatology care in the next 12 months
Who cannot join
- do not expect to live independently
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
McMaster University
Hamilton, Ontario, L8S 4K1
Michelle Batthish, MD, 905-521-2100 ext. 75382, batthim@mcmaster.ca
Karen Beattie, PhD, 905-521-2100 ext. 75382, beattik@mcmaster.ca
About this study
Official title: TRACER - Transition to Adult Care Through Coaching and Empowerment in Rheumatology: A Multicentre Randomized Controlled Trial
The period leading up to and following transfer from pediatric to adult care for youth with rheumatic disease is a vulnerable time leaving youth at risk of poor self-efficacy (confidence in ability to manage all aspects of their health). Adult rheumatologists face barriers in providing the complex medical, developmental and socially supportive care required for this population. Youth have expressed preference for individualized coaching during this period which involves education and support around skills and confidence-building related to their disease. The investigators have completed a feasibility trial of a Transition Coach Intervention (TCI) to help youth with rheumatic diseases gain self-efficacy and better navigate transition to adult care. The investigators will now conduct a randomized-control trial (RCT) at six centres to demonstrate TCI efficacy.
Read the detailed description
Our primary aim is to determine the impact of a TCI on improving self-efficacy in managing medications and treatments in youth with chronic rheumatic diseases, compared to an attention control group. Our secondary aim is to explore whether a TCI improves other domains of the PROMIS Self-Efficacy for Managing Chronic Disease questionnaire (Daily Activities, Emotions, Medications, Social Interactions, and Symptoms), transition readiness and attendance at healthcare appointments in youth with chronic rheumatic diseases, compared to an attention control group.
- Conditions
- Rheumatic Conditions
- Being tested
- transition coaching
- Keywords
- transition to adult healthcare, health coaching, rheumatology, youth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transition coachingBehavioural
8 monthly transition coaching sessions
| Study group | Role | What they receive |
|---|---|---|
| Transition coaching | Experimental | 8 monthly sessions with a transition coach Receives: Behavioral: transition coaching |
| Attention-control | No intervention | Participants receive transition toolkit and 8-monthly phone calls with the research coordinator as a reminder of their participation in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS (Patient-Reported Outcomes Measurement Information System)
Self-efficacy for managing chronic conditions - Self-efficacy is a "positively framed" domain. This means a higher T-score represents greater confidence in managing your condition.
Measured: baseline, 8 and 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startMar 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic ConditionsStudies of the same condition, open and under way.
- 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
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Batthish, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838896
- Sponsor's protocol ID
- 20624
- Acronym
- TRACER
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRACER - Transition to Adult Care Through Coaching and Empowerment in Rheumatology: A Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07838896
- Acronym / sponsor ID
- TRACER / 20624
- Conditions
- Rheumatic Conditions
- Keywords
- transition to adult healthcare, health coaching, rheumatology, youth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 24 Sep 2026 (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.
The period leading up to and following transfer from pediatric to adult care for youth with rheumatic disease is a vulnerable time leaving youth at risk of poor self-efficacy (confidence in ability to manage all aspects of their health). Adult rheumatologists face barriers in providing the complex medical, developmental and socially supportive care required for this population. Youth have expressed preference for individualized coaching during this period which involves education and support around skills and confidence-building related to their disease. The investigators have completed a feasibility trial of a Transition Coach Intervention (TCI) to help youth with rheumatic diseases gain self-efficacy and better navigate transition to adult care. The investigators will now conduct a randomized-control trial (RCT) at six centres to demonstrate TCI efficacy.
Detailed description
Our primary aim is to determine the impact of a TCI on improving self-efficacy in managing medications and treatments in youth with chronic rheumatic diseases, compared to an attention control group. Our secondary aim is to explore whether a TCI improves other domains of the PROMIS Self-Efficacy for Managing Chronic Disease questionnaire (Daily Activities, Emotions, Medications, Social Interactions, and Symptoms), transition readiness and attendance at healthcare appointments in youth with chronic rheumatic diseases, compared to an attention control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Transition coaching | Experimental | Behavioral: transition coaching8 monthly sessions with a transition coach |
| Attention-control | No intervention | –Participants receive transition toolkit and 8-monthly phone calls with the research coordinator as a reminder of their participation in the study. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- will be transferred to adult rheumatology care in the next 12 months
Key exclusion criteria (1 listed)
- do not expect to live independently
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 coaching8 monthly transition coaching sessions | Behavioural | Transition coaching |
Primary outcome
PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: baseline, 8 and 11 months
Self-efficacy for managing chronic conditions - Self-efficacy is a "positively framed" domain. This means a higher T-score represents greater confidence in managing your condition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 coaching in people with Rheumatic Conditions, 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 1 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: opening soon, as of the sponsor's last update on 24 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Batthish, MD (905-521-2100 ext. 75382, batthim@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS (Patient-Reported Outcomes Measurement Information System) (time frame: baseline, 8 and 11 months). 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 24 Sep 2026.