Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

— WebSMART  

Official title:

WebSMART: Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541917
• Other study ID #: GRANT10829275
• Secondary ID: 1R01AR061513-01
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2012
• Last updated: August 12, 2016
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Dell Children's Medical Center of Central Texas	Austin	Texas
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Joseph M. Sanzari Children's Hospital	Hackensack	New Jersey
United States	Riley Hospital for Children	Indianopolis	Indiana
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	The Children's Hospital at Legacy Emmanuel Medical Center	Portland	Oregon
United States	University of California San Francisco Benioff Children's Hospital	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity	Pain intensity will be assessed by patient-self report using an electronic numeric rating scale.	Baseline, post-treatment, 6-month follow-up, 12-month follow-up	No
Primary	Change in Rheumatology Health-Related Quality of Life Total Score	Health-related quality of life will be measured by patient self-report using an electronic version of the PedsQL Rheumatology Module.	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up	No
Secondary	Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score	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	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up	No
Secondary	Change in disease activity	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.	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up	No
Secondary	Change in Children's Arthritis Self-Efficacy (CASE) scores	Confidence in managing arthritis will be measured by patient self-report using an electronic version of the Children's Arthritis Self-Efficacy (CASE) scale.	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up	No
Secondary	Change in Pain Coping Questionnaire scores	Types of pain coping strategies used will be measured by patient self-report using an electronic version of the Pain Coping Questionnaire.	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up	No