View Clinical Trial (Medical Research Study)
Jointstrong Intervention for Juvenile Arthritis
| City: |
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Kansas City |
| State: |
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Kansas |
| Zip Code: |
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66160 |
| Conditions: |
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Juvenile Arthritis |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01166750 |
| Primary Contact: |
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Principal Investigator
Michael Rapoff, Ph D
University of Kansas
Michael Rapoff, Ph D
Phone: 913-588-6323
Email: mrapoff@kumc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Kansas City, Kansas 66160
United States
Michael Rapoff, Ph D
Phone: 913-588-6323
Email: mrapoff@kucm.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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