N/A
N=23
Jointstrong Intervention for Juvenile Arthritis
Juvenile Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01166750 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Pain — 4.3; 5.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CD-ROM (Behavioral); Wait-list Control Group (Behavioral)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Michael Rapoff, Ph.D.
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain |
4.3; 5.7 | — |
| SECONDARY Mood and Stress |
— | — |
| SECONDARY Quality of Life |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01166750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.