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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Juvenile Arthritis
Interventions Behavioral: CD-ROM
Behavioral: Wait-list Control Group
Enrollment 35
Recruitment Details Dates of recruitment were from April 2009 to May 2011.
Pre-assignment Details Twelve subjects were not randomized to groups, 2 due to infrequent pain, 2 moved or phone was disconnected, 6 would not return phone calls, and 2 dropped out as they were too busy.
Arm/Group Title CD-ROM-treatment Wait-list Control Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 10 13
Completed 9 13
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title CD-ROM-treatment Wait-list Control Group Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 10 13 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 13 participants 23 participants
<=18 years
10
 100.0%
13
 100.0%
23
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 13 participants 23 participants
10.3  (1.2) 10.6  (1.6) 10.5  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 13 participants 23 participants
Female
9
  90.0%
9
  69.2%
18
  78.3%
Male
1
  10.0%
4
  30.8%
5
  21.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 13 participants 23 participants
10 13 23
1.Primary Outcome
Title Pain
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
They were the ones still remaining at the end of the study.
Arm/Group Title CD-ROM Treatment Wait-List Control Group
Hide Arm/Group Description:
Jointstrong
[Not Specified]
Overall Number of Participants Analyzed 9 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.3  (1.8) 5.7  (3.3)
2.Secondary Outcome
Title Mood and Stress
Hide Description [Not Specified]
Time Frame weekly for 12 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Quality of Life
Hide Description [Not Specified]
Time Frame weekly for 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CD-ROM-treatment Wait-list Control Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
CD-ROM-treatment Wait-list Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
CD-ROM-treatment Wait-list Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
CD-ROM-treatment Wait-list Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/13 (0.00%) 
It was difficult to find subjects with pain resulting in significantly fewer subjects entered in the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael A. Rapoff, PhD., Principal Investigator
Organization: University of Kansas Medical Center
Phone: 913-588-6323
EMail: mrapoff@kumc.edu
Layout table for additonal information
Responsible Party: Michael Rapoff, Ph.D., University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01166750    
Other Study ID Numbers: 11154
First Submitted: July 19, 2010
First Posted: July 21, 2010
Results First Submitted: September 24, 2012
Results First Posted: May 31, 2013
Last Update Posted: May 31, 2013