跳至主要内容
临床试验/NCT01541917
NCT01541917已完成3 期

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

Children's Mercy Hospital Kansas City20 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2012年7月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
305
试验地点
20
主要终点
Change in Pain Intensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in Pain Intensity

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Sponsor

研究点 (20)

Loading locations...

相似试验