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临床试验/NCT01166750
NCT01166750已完成不适用

Jointstrong Intervention for Juvenile Arthritis

Michael Rapoff, Ph.D.2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Pain

研究概览

简要总结

This study is a randomized wait-list controlled trial with repeated measures. There will be two groups: (1) standard medical care (wait-list control), and (2) standard medical care plus the adjunctive Jointstrong pain coping skills CD-ROM program (treatment). The study will have four phases: Pre-intervention Baseline (2 weeks); Intervention (4 weeks); immediate post-intervention follow up (2 weeks); and 12-week post-intervention follow up (2 weeks). The purpose of this study is to determine if using a CD-ROM program for juvenile arthritis can help children learn how to improve their symptoms on their own and reduce the frequency of symptoms.

详细描述

If your child is eligible and decides to participate in this study, this participation will last approximately eight weeks. Please refer to the table at the end of this consent form.

Your child's participation in this study will involve the completion of daily questionnaires during a one-week baseline period and a one-week follow-up period. These questionnaires will contain various questions about your child's arthritis and his/her ability to do various activities. The questionnaires will take approximately 15-30 minutes each week to complete.

Your child will be randomly assigned to complete one of two CD-ROM programs. One of the CD-ROM programs is a "control" program that contains educational information about arthritis and medical treatments and the other is the "treatment" program and contains the same educational information as the control program plus information on behavioral strategies for controlling symptoms of arthritis. Your child's participation in this study will involve working through one of these CD-ROM programs over a one-month period. Your child will also continue to receive medical treatment from the rheumatologist treating your child for arthritis. The CD-ROM programs involve working through developmentally appropriate lessons on the nature of arthritis and how to treat it. The CD-ROM programs are divided into weekly "modules" and are designed to be completed within four weeks. Lessons take an average of 15 minutes to complete (plus "homework"), and there is an average of 4 lessons to complete each week.

Your participation in this study will involve the completion of questionnaires and helping your child understand any parts of the study that he or she does not understand.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Pain

时间窗: weekly for 12 weeks

Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.

次要结局

  • Quality of Life(weekly for 12 weeks)
  • Mood and Stress(weekly for 12 weeks)

研究者

发起方
Michael Rapoff, Ph.D.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Rapoff, Ph.D.

Professor

University of Kansas Medical Center

研究点 (2)

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