Phase 3
N=289
Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01541917 ↗Enrolled (actual)
289
Serious AEs
3.1%
Results posted
Mar 2017
Primary outcome: Primary: Change in Pain Intensity — 3.56; 3.26; 3.07; 2.90 Units on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Web-based coping skills training (Behavioral); Online disease education (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity |
3.56; 3.26; 3.07; 2.90; 2.87; 2.96 | <.001 sig |
| PRIMARY Change in PedsQL Rheumatology Health-Related Quality of Life Total Score |
72.56; 72.44; 75.68; 77.78; 77.32; 77.12 | <.001 sig |
| SECONDARY Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score |
4.78; 4.57; 6.27; 6.54; 6.62; 6.44 | <.001 sig |
| SECONDARY Change in Disease Activity |
6.97; 6.63; 5.61; 6.43; 5.45; 5.35 | .02 sig |
| SECONDARY Change in Children's Arthritis Self-Efficacy (CASE) Scores |
3.31; 3.32; 3.80; 3.67; 3.81; 3.73 | <.001 sig |
| SECONDARY Change in Approach Coping |
2.63; 2.57; 2.84; 2.67; 2.76; 2.55 | .58 |
Summary
The purpose of this multi-site randomized clinical trial is to determine if an online coping skills training program will produce superior improvements in pain and health-related quality of life outcomes for adolescents with JIA relative to outcomes attained with reviewing online educational information about JIA.
Eligibility Criteria
Inclusion Criteria
- 12-18 years of age (inclusive)
- diagnosed with JIA by a pediatric rheumatologist
- able to speak and read English and/or Spanish
- able to complete online measures
- reporting pain in at least one joint over the past 6 months
Exclusion Criteria
- have another chronic medical condition that adversely impacts pain and/or health-related quality of life (e.g., inflammatory bowel disease, fibromyalgia, cancer, genetic disorder, pervasive developmental disorder, diabetes)
- have a significant cognitive impairment or illiteracy that would prevent understanding of the intervention and outcome measures
- currently in psychotherapy
Data sourced from ClinicalTrials.gov (NCT01541917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.