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Jointstrong Intervention for Juvenile Arthritis

Primary Purpose

Juvenile Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CD-ROM
Wait-list Control Group
Sponsored by
Michael Rapoff, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Arthritis

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CD-ROM-treatment

Wait-list Control Group

Arm Description

Outcomes

Primary Outcome Measures

Pain
Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.

Secondary Outcome Measures

Mood and Stress
Quality of Life

Full Information

First Posted
July 19, 2010
Last Updated
May 30, 2013
Sponsor
Michael Rapoff, Ph.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01166750
Brief Title
Jointstrong Intervention for Juvenile Arthritis
Official Title
Jointstrong Intervention for Juvenile Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Rapoff, Ph.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD-ROM-treatment
Arm Type
Experimental
Arm Title
Wait-list Control Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
CD-ROM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wait-list Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.
Time Frame
weekly for 12 weeks
Secondary Outcome Measure Information:
Title
Mood and Stress
Time Frame
weekly for 12 weeks
Title
Quality of Life
Time Frame
weekly for 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rapoff, Ph D
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Jointstrong Intervention for Juvenile Arthritis

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