Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis (WebSMART)
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.
Juvenile Idiopathic Arthritis
Behavioral: Web-based coping skills training
Behavioral: Online disease education
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||WebSMART: Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis|
- Change in pain intensity [ Time Frame: Baseline, post-treatment, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]Pain intensity will be assessed by patient-self report using an electronic numeric rating scale.
- Change in Rheumatology Health-Related Quality of Life Total Score [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]Health-related quality of life will be measured by patient self-report using an electronic version of the PedsQL Rheumatology Module.
- Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]Knowledge about Juvenile Idiopathic Arthritis will be measured by patient self-report using an electronic version of the Medical Issues, Exercise, Pain and Social support (MEPS) Questionnaire
- Change in disease activity [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]Disease activity will be assessed by the treating physician using a composite index comprising an 11-point global disease severity assessment and a count of the number of joints that are swollen, tender, or limited in range of motion.
- Change in Children's Arthritis Self-Efficacy (CASE) scores [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]Confidence in managing arthritis will be measured by patient self-report using an electronic version of the Children's Arthritis Self-Efficacy (CASE) scale.
- Change in Pain Coping Questionnaire scores [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]Types of pain coping strategies used will be measured by patient self-report using an electronic version of the Pain Coping Questionnaire.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||January 2016|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
|Experimental: Web-based coping skills training||
Behavioral: Web-based coping skills training
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.
|Active Comparator: Online disease education||
Behavioral: Online disease education
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541917
|United States, California|
|University of California San Francisco Benioff Children's Hospital|
|San Francisco, California, United States, 94143|
|United States, Illinois|
|Lurie Children's Hospital|
|Chicago, Illinois, United States, 60614-3363|
|United States, Indiana|
|Riley Hospital for Children|
|Indianopolis, Indiana, United States, 46202|
|United States, Missouri|
|Children's Mercy Hospitals and Clinics|
|Kansas City, Missouri, United States, 64108|
|United States, New Jersey|
|Joseph M. Sanzari Children's Hospital|
|Hackensack, New Jersey, United States, 07601|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|United States, Oregon|
|The Children's Hospital at Legacy Emmanuel Medical Center|
|Portland, Oregon, United States, 97227|
|United States, Texas|
|Dell Children's Medical Center of Central Texas|
|Austin, Texas, United States, 78723|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98133|
|Principal Investigator:||Mark A Connelly, PhD||Children's Mercy Hospital Kansas City|
|Principal Investigator:||Jennifer Stinson, PhD||The Hospital for Sick Children|