Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
WebSMART
WebSMART: Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
2 other identifiers
interventional
305
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2012
Typical duration for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2012
CompletedFirst Posted
Study publicly available on registry
March 1, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
March 9, 2017
CompletedMarch 9, 2017
January 1, 2017
3.8 years
February 24, 2012
November 21, 2016
January 18, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Pain Intensity
Pain intensity was assessed by patient-self report using an electronic numeric rating scale ranging from 0-10, with 0 being the lowest value ("no pain") and 10 being the highest value ("very much pain").
Baseline, post-treatment, 6-month follow-up, 12-month follow-up
Change in PedsQL Rheumatology Health-Related Quality of Life Total Score
Health-related quality of life was measured by patient self-report using an electronic version of the PedsQL Rheumatology Module. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.
Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Secondary Outcomes (4)
Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score
Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Change in Disease Activity
Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Change in Children's Arthritis Self-Efficacy (CASE) Scores
Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Change in Approach Coping
Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Study Arms (2)
Web-based coping skills training
EXPERIMENTALInvolves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.
Online disease education
ACTIVE COMPARATORInvolves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of California San Francisco Benioff Children's Hospital
San Francisco, California, 94143, United States
Lurie Children's Hospital
Chicago, Illinois, 60614-3363, United States
Riley Hospital for Children
Indianopolis, Indiana, 46202, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, 07601, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Children's Hospital at Legacy Emmanuel Medical Center
Portland, Oregon, 97227, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Seattle Children's Hospital
Seattle, Washington, 98133, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Connelly, PhD (Principal Investigator)
- Organization
- Children's Mercy Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Connelly, PhD
Children's Mercy Hospital Kansas City
- PRINCIPAL INVESTIGATOR
Jennifer Stinson, PhD
The Hospital for Sick Children
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2012
First Posted
March 1, 2012
Study Start
July 1, 2012
Primary Completion
April 1, 2016
Study Completion
June 1, 2016
Last Updated
March 9, 2017
Results First Posted
March 9, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
A deidentified dataset is available for secondary analyses per our Resource Sharing Plan.