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Transition Coaching for Juvenile Arthritis (TRACER Trial)
N/A
Recruiting
Led By Michelle Batthish, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 year study period
Awards & highlights
No Placebo-Only Group
Summary
This trial will help find out if transition coaching sessions can help young people with rheumatology conditions move from paediatric to adult care.
Who is the study for?
This trial is for young people with pediatric-onset rheumatic diseases like arthritis and lupus, who are transitioning to adult care. Participants need a phone or device for video calls, must be available for the next 8 months, and able to communicate in English. Those with cognitive impairments that prevent participation in educational sessions cannot join.
What is being tested?
The TRACER study is testing transition coaching sessions designed to help patients move from pediatric to adult rheumatology care smoothly. The feasibility of these coaching interventions through video conferencing will be evaluated.
What are the potential side effects?
Since this trial involves non-medical intervention (coaching), there are no direct physical side effects associated with medications or procedures. However, participants may experience stress or anxiety related to the transition process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 year study period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 year study period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Consent rate
Enrolment from non-primary site
Missing data
+2 moreSecondary study objectives
Active joint count
Global function/quality of life
Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transition coaching - experimentalExperimental Treatment1 Intervention
Participants will receive 8 transition coaching sessions (1/month) in addition to standard care
Group II: Standard care - controlActive Control1 Intervention
Standard of care, appointments with adult rheumatology
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Who is running the clinical trial?
McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,615,095 Total Patients Enrolled
Western UniversityOTHER
29 Previous Clinical Trials
128,598 Total Patients Enrolled
Michelle Batthish, MDPrincipal InvestigatorMcMaster University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had my last pediatric rheumatology appointment before moving to adult care.My thinking or memory problems prevent me from learning new health information.You were diagnosed with a rheumatic disease when you were a child.
Research Study Groups:
This trial has the following groups:- Group 1: Standard care - control
- Group 2: Transition coaching - experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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