A Virtual Self-Management Intervention for Adolescents With Juvenile Idiopathic Arthritis: Protocol for the VISTA-JIA Randomized Controlled Trial.

Abstract

Background: Needs assessments in patients with juvenile idiopathic arthritis (JIA) have revealed a need for disease information, self-management skills, and peer support. We previously developed and tested the acceptability of an in-person and videoconference-based self-management program (SMP) to address these needs.

Objective: The aim of this pilot randomized controlled trial (RCT; the VISTA-JIA trial) is to evaluate the feasibility and preliminary effectiveness of a virtual group-based SMP for adolescents with JIA in comparison to a waitlist control group.

Methods: A total of 100 participants with confirmed JIA (aged 12-17 years) will be recruited from 5 Canadian pediatric rheumatology centers and randomized 1:1 to the intervention or waitlist control groups. Adolescents in the intervention group will receive the virtual SMP. Those randomized to the control group will receive standard of care alone and will later be eligible for the SMP. The SMP includes JIA disease education, self-management strategies, and peer support. Four 60- to 90-minute sessions will be conducted over 8 weeks with a group size of 4-6 participants. The primary feasibility outcome will be adherence to the SMP (defined as completion of all 4 sessions by at least 80% of participants). Other secondary feasibility outcomes will include recruitment and withdrawal rates, the proportion of completed questionnaires, engagement and satisfaction with the SMP measured through a semistructured virtual interview, and intervention fidelity (consistent content and technology delivery). Secondary preliminary effectiveness outcomes will be assessed by completing 5 validated questionnaires at pre- and postprogram time points: (1) the Medical Issues, Exercise, Pain, and Social Support Questionnaire to assess perceived ability to manage JIA (self-management); (2) the Children's Arthritis Self-Efficacy Scale to assess self-efficacy; (3) the Pediatric Quality of Life Inventory 3.0 Rheumatology-Teen Module to assess health-related quality of life; (4) the PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference Scale to assess pain interference; and (5) Readiness for Adult Care in Rheumatology to assess transition readiness. Descriptive statistics and nonparametric tests will be used to analyze the data.

Results: The study setup is complete at all centers, including training of the facilitators, revising and finalizing education sessions, participant's handout guide, and fidelity checklist. Recruitment began in January 2024 and is expected to conclude by December 2025. Feasibility outcomes, including adherence and engagement, as well as preliminary effectiveness, will be analyzed post intervention.

Conclusions: This is the first evidence-based, virtual, interactive, group-structured JIA SMP in Canada. This SMP will address needs for disease information, self-management skills, and peer support in adolescents with JIA. The results of this pilot study will inform a full-scale RCT focused on the efficacy and cost-effectiveness of the program with the goal of integration in routine clinical practice across Canada.

Trial registration: ClinicalTrials.gov NCT06184100; https://clinicaltrials.gov/study/NCT06184100.

International registered report identifier (irrid): DERR1-10.2196/69539.