Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      There is a critical gap in the contemporary treatment of Juvenile Idiopathic Arthritis (JIA)
      wherein a majority of adolescent patients still experience ongoing pain and reduced
      health-related quality of life even with advances in medical management of the disease.
      Despite the pervasiveness of this problem, most adolescents receive no training in the
      strategies that can help empower them to reduce pain and disability. The Internet offers a
      unique opportunity to reach adolescents with JIA and provide the training in pain
      self-management strategies that otherwise may not occur due to treatment access and resource
      obstacles. The objective of this research study is to conduct a definitive test of an
      investigator-developed online coping skills training program for English- and
      Spanish-speaking adolescents with JIA. Based on data from the investigators' preliminary
      work, the central hypothesis is that use of 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 extant online educational
      information about JIA and receiving additional attention to coping efforts (control
      condition). Specific aims for the proposed work include (a) determining the extent to which
      an online coping skills training program for adolescents with JIA produces improvements in
      key health outcomes that currently do not optimally respond to only contemporary medical
      management (pain and health-related quality of life); and (b) determining predictors of
      change in pain and health-related quality of life indices in adolescents with JIA and
      establishing the extent to which online coping skills training influences health outcomes via
      these predictors. An exploratory aim is to determine the acceptability and preliminary
      efficacy of online coping skills training within a subgroup of Hispanic adolescents with JIA.
      These aims will be achieved through the approach of using a multi-center randomized
      controlled trial in which a sample of 360 consenting English- and Spanish-speaking
      adolescents aged 12-18 years with JIA will be enrolled and randomized into one of two groups:
      (a) an experimental group consisting of a 12-week interactive online multi-component
      treatment protocol including targeted disease education, training in empirically supported
      cognitive-behavioral coping skills, and social support augmented by monthly telephone contact
      with a nurse; or (b) a control group consisting of 12 weeks of guided access to extant online
      resources for disease education and additional attention to own best efforts at managing JIA
      via monthly telephone contact with a nurse. Outcome data will be collected from both groups
      prior to treatment, immediately following the intervention, and at 6- and 12-month follow-up
      assessments. Successful completion of this project is expected to establish to what extent
      and how an innovative online self-management program produces change in clinically relevant
      health outcomes in both English- and Spanish-speaking adolescents with JIA. The proposed
      study therefore can be expected to have a significant positive impact in the healthcare of
      teens with JIA and in identifying treatment targets for other youth self-management
      interventions.
    

Intervention name(s): Web-based coping skills training; Online disease education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.; The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment