Jointstrong Intervention for Juvenile Arthritis
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 19, 2010
CompletedFirst Posted
Study publicly available on registry
July 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
May 31, 2013
CompletedMay 31, 2013
May 1, 2013
1.9 years
July 19, 2010
September 24, 2012
May 30, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Pain
Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.
weekly for 12 weeks
Secondary Outcomes (2)
Mood and Stress
weekly for 12 weeks
Quality of Life
weekly for 12 weeks
Study Arms (2)
CD-ROM-treatment
EXPERIMENTALWait-list Control Group
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
It was difficult to find subjects with pain resulting in significantly fewer subjects entered in the study.
Results Point of Contact
- Title
- Michael A. Rapoff, PhD., Principal Investigator
- Organization
- University of Kansas Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Rapoff, Ph D
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 19, 2010
First Posted
July 21, 2010
Study Start
April 1, 2009
Primary Completion
March 1, 2011
Study Completion
May 1, 2011
Last Updated
May 31, 2013
Results First Posted
May 31, 2013
Record last verified: 2013-05