NCT05310799 Personalized Estimates of Response and Severity Outcomes in Newly-diagnosed JIA
| NCT ID | NCT05310799 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Juvenile Idiopathic Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 842 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 842 participants in total. It began in 2023-05-23 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The PERSON-JIA Trial is a cluster-randomized trial testing the use of Shared Decision Making (SDM) with families for treatment of children with arthritis. The intervention is a discussion between physicians and families at the time of diagnosis that uses computer-generated personalized outcome reports generated by previously developed prediction algorithms. By using information provided by thousands of families, the investigators have developed a way of providing answers to common questions asked by patients and their families at diagnosis. We will test whether a structured discussion and shared decision between families and doctors (guided by the patient's personal report) will improve the tailoring of treatment to the child and control of their disease. The personal report is called the PERSON-JIA report and presents the child's expected disease severity, the likelihood the child will be arthritis free by age 18 and the chance treatments will be effective and/or have side effects. This way, answers to these questions can be shared by physicians and families to weigh potential benefits and harms according to family values and preferences. The investigators expect that using the personalized report in a frank and thoughtful discussion will help physicians and families make better decisions about managing the child's disease. This in turn will result in better disease control, greater family engagement and satisfaction with care and better-tailored treatment. If so, this will be a ground-breaking way of using information provided by families and doctors to improve the care provided to and the outcomes of children with arthritis in Canada.
Eligibility Criteria
Physicians (Inclusion): 1. Licensed to practice pediatric rheumatology in Canada; 2. Providing care for children with JIA at least once a month; 3. Consent to be randomized and to implement the SDM intervention for the duration of the trial, if randomized to the intervention arm; 4. Commit to propose enrollment in the Registry to all their newly diagnosed patients with JIA during the trial. Physicians (Exclusion): 1. Fellows-in-training; 2. Physicians planning to retire within 2 years. Patient (Inclusion): 1. Consent to include their information in the CAPRI JIA Registry; 2. Consent to the PERSON-JIA trial and answering additional questionnaires to assess decision making; 3. Allow recording of their medical encounter (if selected at random); 4. JIA fulfilling International League of Associations for Rheumatology (ILAR) criteria; 5. Newly diagnosed (within the last month); 6. Diagnosed by a pediatric rheumatologist participating in the PERSON-JIA study; 7. Not yet receiving treatment, or received only Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) or joint injections; Patient (Exclusion): 1. Systemic arthritis category of JIA (it requires a different treatment approach); 2. Family is unable to complete study forms in English or French; 3. Patients who have already started systemic corticosteroid or any Disease Modifying Anti-Rheumatic Drug (DMARD).
Contact & Investigator
Lori B Tucker, MD
PRINCIPAL INVESTIGATOR
University of British Columbia Department of Pediatrics
Frequently Asked Questions
Who can join the NCT05310799 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Juvenile Idiopathic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05310799 currently recruiting?
Yes, NCT05310799 is actively recruiting participants. Contact the research team at jguzman@cw.bc.ca for enrollment information.
Where is the NCT05310799 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT05310799 clinical trial?
NCT05310799 is sponsored by University of British Columbia. The principal investigator is Lori B Tucker, MD at University of British Columbia Department of Pediatrics. The trial plans to enroll 842 participants.