Clinical trial NCT01541917: Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
Official title: WebSMART: Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2012-03-01
Enrollment: 305
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Baseline, post-treatment, 6-month follow-up, 12-month follow-up
measure: Change in PedsQL Rheumatology Health-Related Quality of Life Total Score
timeFrame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Secondary outcomes:
measure: Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score
timeFrame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
measure: Change in Disease Activity
timeFrame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
measure: Change in Children's Arthritis Self-Efficacy (CASE) Scores
timeFrame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
measure: Change in Approach Coping
timeFrame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Benioff Children's Hospital
state: California
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Indianopolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Hackensack
country: United States
facility: Joseph M. Sanzari Children's Hospital
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Portland
country: United States
facility: The Children's Hospital at Legacy Emmanuel Medical Center
state: Oregon
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Mark A Connelly, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Jennifer Stinson, PhD
role: PRINCIPAL_INVESTIGATOR
References: