Trial Outcomes & Findings for Jointstrong Intervention for Juvenile Arthritis (NCT NCT01166750)
NCT ID: NCT01166750
Last Updated: 2013-05-31
Results Overview
Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
weekly for 12 weeks
Results posted on
2013-05-31
Participant Flow
Dates of recruitment were from April 2009 to May 2011.
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.
Participant milestones
| Measure |
CD-ROM-treatment
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
|
Overall Study
COMPLETED
|
9
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
CD-ROM-treatment
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
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Jointstrong Intervention for Juvenile Arthritis
Baseline characteristics by cohort
| Measure |
CD-ROM-treatment
n=10 Participants
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
n=13 Participants
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
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
10.3 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
10.6 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
10.5 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weekly for 12 weeksPopulation: They were the ones still remaining at the end of the study.
Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.
Outcome measures
| Measure |
CD-ROM Treatment
n=9 Participants
Jointstrong
|
Wait-List Control Group
n=13 Participants
|
|---|---|---|
|
Pain
|
4.3 units on a scale
Standard Deviation 1.8
|
5.7 units on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: weekly for 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: weekly for 12 weeksOutcome measures
Outcome data not reported
Adverse Events
CD-ROM-treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael A. Rapoff, PhD., Principal Investigator
University of Kansas Medical Center
Phone: 913-588-6323
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place