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Jointstrong Intervention for Juvenile Arthritis

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ClinicalTrials.gov Identifier: NCT01166750
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Michael Rapoff, Ph.D., University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE July 19, 2010
First Posted Date  ICMJE July 21, 2010
Results First Submitted Date  ICMJE September 24, 2012
Results First Posted Date  ICMJE May 31, 2013
Last Update Posted Date May 31, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
Pain [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2010)
Pain [ Time Frame: weekly for 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2010)
  • Mood and Stress [ Time Frame: weekly for 12 weeks ]
  • Quality of Life [ Time Frame: weekly for 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Jointstrong Intervention for Juvenile Arthritis
Official Title  ICMJE Jointstrong Intervention for Juvenile Arthritis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Juvenile Arthritis
Intervention  ICMJE
  • Behavioral: CD-ROM
    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.
  • 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.
Study Arms  ICMJE
  • Experimental: CD-ROM-treatment
    Intervention: Behavioral: CD-ROM
  • Active Comparator: Wait-list Control Group
    Intervention: Behavioral: Wait-list Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
35
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2010)
36
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria. Patients recruited for this study will meet the following inclusion criteria: (a) are 8-12 years of age; (b) have a diagnosis of JA by a pediatric rheumatologist using established criteria, and (c) have JA-related (joint) pain occurring on an average of at least once per week by patient report [9]. Participants in the age range 8-12 years will be recruited because the intervention will be tailored to children (future studies will involve creating and testing a version of Jointstrong for adolescents). Although access to a home computer with a CD-ROM drive is required for the study, this will not be an inclusion criterion, and we expect the lack of access will be rare, as our pilot data on 37 children with headaches found that only 2% (1 child) did not have adequate home computer access [15]. So as not to exclude the few children without access who otherwise qualify for the study, we will lend laptop computers to these children. All children meeting symptom inclusion criteria will therefore be able to use the adjunctive CD-ROM programs in a home setting.

Exclusion Criteria. Patients will be excluded from the study if (a) their parents or rheumatologist report they have been diagnosed with a mental health condition or they are receiving concurrent psychotherapy; or (b) their 14-day baseline pain diaries indicate they have pain, on average, less than one day per week; or (c) they do not speak English.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01166750
Other Study ID Numbers  ICMJE 11154
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Rapoff, Ph.D., University of Kansas Medical Center
Study Sponsor  ICMJE Michael Rapoff, Ph.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Rapoff, Ph D University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP