Jointstrong Intervention for Juvenile Arthritis
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Jointstrong Intervention for Juvenile Arthritis|
- Pain [ Time Frame: weekly for 12 weeks ] [ Designated as safety issue: No ]Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.
- Mood and Stress [ Time Frame: weekly for 12 weeks ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: weekly for 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the "pain puzzle") as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material.
|Active Comparator: Wait-list Control Group||
Behavioral: Wait-list Control Group
Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166750
|United States, Kansas|
|University Of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Michael Rapoff, Ph D||University of Kansas|