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Behavioural Intervention

Shared Decision Making for Juvenile Arthritis (PERSON-JIA Trial)

N/A

Recruiting

Led By Lori B Tucker, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have JIA fulfilling International League of Associations for Rheumatology (ILAR) criteria

Patients must not yet be receiving treatment, or have received only Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) or joint injections

Must not have

Patients with systemic arthritis category of JIA (it requires a different treatment approach)

Patients who have already started systemic corticosteroid or any Disease Modifying Anti-Rheumatic Drug (DMARD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to 6 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a discussion between physicians and families, using a computer-generated personalized outcome report, will improve the tailoring of treatment to the child and control of their disease.

Who is the study for?

This trial is for children newly diagnosed with Juvenile Idiopathic Arthritis (JIA), except those with systemic arthritis. They must be diagnosed by a participating pediatric rheumatologist, not yet on treatment or only on NSAIDs/joint injections, and able to complete forms in English or French.

What is being tested?

The PERSON-JIA Trial tests Shared Decision Making (SDM) using personalized outcome reports to guide treatment discussions between doctors and families of children with JIA. It aims to tailor treatments better and improve disease control through informed decisions.

What are the potential side effects?

Since the intervention involves decision-making rather than medication, there are no direct side effects from drugs being tested. However, choices made after SDM may lead to varying outcomes based on selected treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with juvenile idiopathic arthritis according to ILAR criteria.

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I have only used NSAIDs or had joint injections for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have systemic juvenile idiopathic arthritis.

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I am currently taking steroids or drugs for rheumatic diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease

Secondary study objectives

Change in Health Utilities

Change in Parent-Reported Health-Related Quality of Life

Change in Patient-Reported Health-Related Quality of Life

+8 more

Awards & 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: Shared Decision Making (SDM)Experimental Treatment1 Intervention

Physicians will use the PERSON-JIA Report to guide discussions with the newly diagnosed patient and family. The intervention will not dictate the use of specific medications or treatment strategies, only facilitate better informed treatment choices according to patient circumstances. The intervention is a structured SDM discussion between physician and family, occurring at the time of the child's JIA diagnosis. Discussion is guided by the PERSON-JIA Report, which is generated in real time, on the physician's smart phone. Patients newly-diagnosed with JIA will be consented to both enrollment in the CAPRI Registry and enrollment in the PERSON-JIA trial. Clinic visit and discussion between the physician, patient and family will be facilitated by the PERSON-JIA report to support a shared decision making process. Questionnaires will be collected at enrollment, at the second visit and at 6-month and 12-month follow-up visits.

Group II: Current Best PracticeActive Control1 Intervention

Physicians randomized to this arm will provide current care and treatment decisions with patients will be made in accordance with current best practices. Will not engage in structured shared decision making (SDM) discussion and will not have access to PERSON-JIA Reports. Patients will be consented to enroll in the CAPRI Registry at the clinic visit when they are diagnosed. Registry enrollment will allow collection and input of clinical data into the Registry. Clinic visit and discussion will remain unchanged for physicians, patients and their families. Questionnaires will be collected at enrollment, at the second visit and a 6-month and 12-month follow-up visits.

0 / 4Eligibility criteria met