Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis (WebSMART)
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|ClinicalTrials.gov Identifier: NCT01541917|
Recruitment Status : Completed
First Posted : March 1, 2012
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Idiopathic Arthritis||Behavioral: Web-based coping skills training Behavioral: Online disease education||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||305 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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").
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541917
|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|
|Principal Investigator:||Mark A Connelly, PhD||Children's Mercy Hospital Kansas City|
|Principal Investigator:||Jennifer Stinson, PhD||The Hospital for Sick Children|