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

Study Description

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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.

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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	305 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	WebSMART: Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
Study Start Date :	July 2012
Actual Primary Completion Date :	April 2016
Actual Study Completion Date :	June 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Web-based coping skills training; Involves 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.	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; Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.	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.

Outcome Measures

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Primary Outcome Measures :

1. Change in Pain Intensity [ Time Frame: Baseline, post-treatment, 6-month follow-up, 12-month follow-up ]
   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").
2. Change in PedsQL Rheumatology Health-Related Quality of Life Total Score [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ]
   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.

Secondary Outcome Measures :

1. 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 ]
   Knowledge about Juvenile Idiopathic Arthritis was measured by patient self-report using an electronic version of the Medical Issues, Exercise, Pain and Social support (MEPS) Questionnaire. Responses on this scale are measured on a 0-10 numeric rating scale and averaged together to form a summary score, with 0 being the worst possible score and 10 being the best possible score.
2. Change in Disease Activity [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ]
   Disease activity was assessed by the treating physician based on a complete joint count (count of the number of joints that are swollen, painful, tender, or restriction in motion). The lowest (best) value is 0, and the highest (worst) possible value is 300.
3. Change in Children's Arthritis Self-Efficacy (CASE) Scores [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ]
   Confidence in managing arthritis was measured by patient self-report using an electronic version of the Children's Arthritis Self-Efficacy (CASE) scale. Responses on a 5-point scale ("not at all sure" to "very sure") are averaged together to form a total score, with 0 being the worst possible value and 5 being the best possible value.
4. Change in Approach Coping [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ]
   Scores on the Approach Coping sub-scale of the Pain Coping Questionnaire were used to measure approach coping, which is a type of coping considered to be adaptive and helpful for pain. Responses to items on this subscale are on a 5-point scale ("never use" to "very often use") and are averaged together for the subscale score, such that scores range from a worst possible value of 1 to a best possible value of 5.

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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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

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT01541917 History of Changes
Other Study ID Numbers:	GRANT10829275; 1R01AR061513-01 ( U.S. NIH Grant/Contract )
First Posted:	March 1, 2012
Results First Posted:	March 9, 2017
Last Update Posted:	March 9, 2017
Last Verified:	January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	A deidentified dataset is available for secondary analyses per our Resource Sharing Plan.

Additional relevant MeSH terms:

Arthritis; Arthritis, Juvenile; Joint Diseases; Musculoskeletal Diseases	Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases