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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01541917
First received: February 24, 2012
Last updated: February 2, 2015
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Juvenile Idiopathic Arthritis
Behavioral: Web-based coping skills training
Behavioral: Online disease education
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 360
Study Start Date: July 2012
Estimated Study Completion Date: January 2016
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541917

Locations
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
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Mark A Connelly, PhD Children's Mercy Hospital Kansas City
Principal Investigator: Jennifer Stinson, PhD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01541917     History of Changes
Other Study ID Numbers: GRANT10829275, 1R01AR061513-01
Study First Received: February 24, 2012
Last Updated: February 2, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 31, 2015