Jointstrong Intervention for Juvenile Arthritis

Not Applicable

Completed

• Conditions: Juvenile Arthritis
• Interventions: Behavioral: CD-ROM; Behavioral: Wait-list Control Group

• Registration Number: NCT01166750
• Lead Sponsor: Michael Rapoff, Ph.D.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-21
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Results First Submitted: 2012-09-24
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Results First Posted: 2013-05-31
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD-ROM-treatment	CD-ROM	-
Wait-list Control Group	Wait-list Control Group	-

Primary Outcome Measures

Name	Time	Method
Pain	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.

Secondary Outcome Measures

Name	Time	Method
Mood and Stress	weekly for 12 weeks
Quality of Life	weekly for 12 weeks

Trial Locations

Locations (1)

University Of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States