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A Study Protocol for the Management of Children With Juvenile Idiopathic Arthritis Based on ePROs
Biyu Shen1,2, Songsong Shi1, Hengmei Cui1
1Department of Nursing, Shanghai Children's Medical Center, Shanghai, China.
Insights
This study investigates electronic patient-reported outcome (ePRO) symptom management for juvenile idiopathic arthritis (JIA) in children. Findings suggest ePROs improve JIA symptom management and monitoring, offering a feasible intervention.
Area of Science:
- Pediatric Rheumatology
- Digital Health
- Clinical Trial Methodology
Background:
- Juvenile idiopathic arthritis (JIA) is a chronic rheumatic disease in children under 16.
- Patient-reported outcomes (PROs) are crucial for evaluating JIA impact and treatments.
- Challenges exist in pediatric PRO implementation and ePROs for JIA symptom management remain understudied.
Purpose of the Study:
- To evaluate the effect and usability of electronic PROs (ePROs) for symptom management in children with JIA.
- To compare individualized ePRO-based management with routine care.
- To assess PROs and health-related quality of life (HRQOL) over 12 months.
Main Methods:
- A longitudinal, randomized controlled trial involving 100 children with JIA.
- Participants were randomized to ePRO-based symptom management or routine management.
- Data collected at baseline and 1, 3, 6, and 12 months, focusing on C-Ped-PROMIS T-scores and HRQOL.
Main Results:
- The study is expected to demonstrate improved JIA symptom management in the ePRO group.
- ePRO-based management is anticipated to be a feasible and effective monitoring tool.
- The relationship between C-Ped-PROMIS T-scores and HRQOL will be analyzed.
Conclusions:
- Symptom management based on ePROs is expected to enhance outcomes for children with JIA.
- ePROs offer a viable and effective approach for monitoring and intervening in pediatric JIA.
- This study provides evidence for the utility of digital health tools in pediatric rheumatology.
Background:
Juvenile idiopathic arthritis (JIA) is a common chronic rheumatic disease with no known cures, affecting children with the age of onset under 16 years. Patient-reported outcome (PRO) measures are an important basis for evaluating the impact of JIA and associated therapies, however, which is particular challenge in the pediatric setting. At present, no randomized controlled studies have investigated the effect and usability of ePROs symptom management for children with JIA.
Methods:
This longitudinal, randomized, controlled trial will be carried out at outpatient and pediatric wards of the Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University School of Medicine. A total of one hundred children with JIA diagnosed according to the International League of Associations for Rheumatology (ILAR) patients are randomized to receive individualized symptom management based on ePROs or routine management. The primary outcome is the mean C-Ped-PROMIS T-scores of patients in the ePROs-based group and the control group. The secondary outcomes are the trajectories of C-Ped-PROMIS T-scores and HRQOL scores, and changing relationship between them. Data were collected at 5 time points: at enrollment ("baseline") and at the time of follow-up visits scheduled at 1, 3, 6, and 12 months.
Discussion:
The findings are expected to conclude that the symptom management based on ePROs for children with JIA can improve the symptom of JIA, and it is a feasible and effective way to monitor and intervene children with JIA.
Clinical Trial:
http://www.chictr.org.cn/showproj.aspx?proj=132769; (ChiCTR2100050503).
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