A Phase 3 interventional study of Web-based coping skills training and Online disease education in Juvenile Idiopathic Arthritis, sponsored by Children's Mercy Hospital Kansas City. Completed at 10 sites in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-03-09.
Sponsored by Children's Mercy Hospital Kansas City · Phase 3, Interventional, and Treatment
The purpose of this multi-site randomized clinical trial is to determine if an online coping skills training program will produce superior improvements in pain and health-related quality of life outcomes for adolescents with JIA relative to outcomes attained with reviewing online educational information about JIA.
There is a critical gap in the contemporary treatment of Juvenile Idiopathic Arthritis (JIA) wherein a majority of adolescent patients still experience ongoing pain and reduced health-related quality of life even with advances in medical management of the disease. Despite the pervasiveness of this problem, most adolescents receive no training in the strategies that can help empower them to reduce pain and disability. The Internet offers a unique opportunity to reach adolescents with JIA and provide the training in pain self-management strategies that otherwise may not occur due to treatment access and resource obstacles. The objective of this research study is to conduct a definitive test of an investigator-developed online coping skills training program for English- and Spanish-speaking adolescents with JIA. Based on data from the investigators' preliminary work, the central hypothesis is that use of an online coping skills training program will produce superior improvements in pain and health-related quality of life outcomes for adolescents with JIA relative to outcomes attained with reviewing extant online educational information about JIA and receiving additional attention to coping efforts (control condition). Specific aims for the proposed work include (a) determining the extent to which an online coping skills training program for adolescents with JIA produces improvements in key health outcomes that currently do not optimally respond to only contemporary medical management (pain and health-related quality of life); and (b) determining predictors of change in pain and health-related quality of life indices in adolescents with JIA and establishing the extent to which online coping skills training influences health outcomes via these predictors. An exploratory aim is to determine the acceptability and preliminary efficacy of online coping skills training within a subgroup of Hispanic adolescents with JIA. These aims will be achieved through the approach of using a multi-center randomized controlled trial in which a sample of 360 consenting English- and Spanish-speaking adolescents aged 12-18 years with JIA will be enrolled and randomized into one of two groups: (a) an experimental group consisting of a 12-week interactive online multi-component treatment protocol including targeted disease education, training in empirically supported cognitive-behavioral coping skills, and social support augmented by monthly telephone contact with a nurse; or (b) a control group consisting of 12 weeks of guided access to extant online resources for disease education and additional attention to own best efforts at managing JIA via monthly telephone contact with a nurse. Outcome data will be collected from both groups prior to treatment, immediately following the intervention, and at 6- and 12-month follow-up assessments. Successful completion of this project is expected to establish to what extent and how an innovative online self-management program produces change in clinically relevant health outcomes in both English- and Spanish-speaking adolescents with JIA. The proposed study therefore can be expected to have a significant positive impact in the healthcare of teens with JIA and in identifying treatment targets for other youth self-management interventions.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 305 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
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Exclusion Criteria:
Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.
Behavioral: Web-based coping skills training
Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.
Behavioral: Online disease education
This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
Change in Pain Intensity
Pain intensity was assessed by patient-self report using an electronic numeric rating scale ranging from 0-10, with 0 being the lowest value ("no pain") and 10 being the highest value ("very much pain").
Time frame: Baseline, post-treatment, 6-month follow-up, 12-month follow-up
Change in PedsQL Rheumatology Health-Related Quality of Life Total Score
Health-related quality of life was measured by patient self-report using an electronic version of the PedsQL Rheumatology Module. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.
Time frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score
Knowledge about Juvenile Idiopathic Arthritis was measured by patient self-report using an electronic version of the Medical Issues, Exercise, Pain and Social support (MEPS) Questionnaire. Responses on this scale are measured on a 0-10 numeric rating scale and averaged together to form a summary score, with 0 being the worst possible score and 10 being the best possible score.
Time frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Change in Disease Activity
Disease activity was assessed by the treating physician based on a complete joint count (count of the number of joints that are swollen, painful, tender, or restriction in motion). The lowest (best) value is 0, and the highest (worst) possible value is 300.
Time frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Change in Children's Arthritis Self-Efficacy (CASE) Scores
Confidence in managing arthritis was measured by patient self-report using an electronic version of the Children's Arthritis Self-Efficacy (CASE) scale. Responses on a 5-point scale ("not at all sure" to "very sure") are averaged together to form a total score, with 0 being the worst possible value and 5 being the best possible value.
Time frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Change in Approach Coping
Scores on the Approach Coping sub-scale of the Pain Coping Questionnaire were used to measure approach coping, which is a type of coping considered to be adaptive and helpful for pain. Responses to items on this subscale are on a 5-point scale ("never use" to "very often use") and are averaged together for the subscale score, such that scores range from a worst possible value of 1 to a best possible value of 5.
Time frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
| Milestone | Web-based Coping Skills Training | Online Disease Education Control |
|---|---|---|
| Started | 144 | 145 |
| Completed | 129 | 136 |
| Not completed | 15 | 9 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Withdrawal by subject | 13 | 7 |
Pain intensity was assessed by patient-self report using an electronic numeric rating scale ranging from 0-10, with 0 being the lowest value ("no pain") and 10 being the highest value ("very much pain").
| Units on a scale | Web-based Coping Skills Training | Online Disease Education Control |
|---|---|---|
| Baseline | 3.56 ± 2.33 | 3.26 ± 2.38 |
| Post-Treatment | 3.07 ± 2.47 | 2.90 ± 2.45 |
| 6-Month Follow-Up | 2.87 ± 2.45 | 2.96 ± 2.29 |
| 12-Month Follow-Up | 3.07 ± 2.49 | 2.71 ± 2.43 |
Health-related quality of life was measured by patient self-report using an electronic version of the PedsQL Rheumatology Module. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.
| units on a scale | Web-based Coping Skills Training | Online Disease Education |
|---|---|---|
| Baseline | 72.56 ± 15.52 | 72.44 ± 15.81 |
| Post-Treatment | 75.68 ± 16.68 | 77.78 ± 15.02 |
| 6-Month Follow-Up | 77.32 ± 15.64 | 77.12 ± 14.41 |
| 12-Month Follow-Up | 78.26 ± 16.23 | 78.04 ± 14.33 |
Knowledge about Juvenile Idiopathic Arthritis was measured by patient self-report using an electronic version of the Medical Issues, Exercise, Pain and Social support (MEPS) Questionnaire. Responses on this scale are measured on a 0-10 numeric rating scale and averaged together to form a summary score, with 0 being the worst possible score and 10 being the best possible score.
| units on a scale | Web-based Coping Skills Training | Online Disease Education |
|---|---|---|
| Baseline | 4.78 ± 2.35 | 4.57 ± 2.20 |
| Post-Treatment | 6.27 ± 2.35 | 6.54 ± 2.03 |
| 6-Month Follow-Up | 6.62 ± 2.47 | 6.44 ± 2.40 |
| 12-Month Follow-Up | 6.45 ± 2.62 | 6.65 ± 2.28 |
Disease activity was assessed by the treating physician based on a complete joint count (count of the number of joints that are swollen, painful, tender, or restriction in motion). The lowest (best) value is 0, and the highest (worst) possible value is 300.
| joints | Web-based Coping Skills Training | Online Disease Education Control |
|---|---|---|
| Baseline | 6.97 ± 12.84 | 6.63 ± 11.18 |
| Post-Treatment | 5.61 ± 9.69 | 6.43 ± 10.09 |
| 6-Month Follow-Up | 5.45 ± 8.29 | 5.35 ± 8.14 |
| 12-Month Follow-Up | 4.53 ± 7.68 | 6.17 ± 9.90 |
Confidence in managing arthritis was measured by patient self-report using an electronic version of the Children's Arthritis Self-Efficacy (CASE) scale. Responses on a 5-point scale ("not at all sure" to "very sure") are averaged together to form a total score, with 0 being the worst possible value and 5 being the best possible value.
| units on a scale | Web-based Coping Skills Training | Online Disease Education Control |
|---|---|---|
| Baseline | 3.31 ± .96 | 3.32 ± 1.05 |
| Post-Treatment | 3.80 ± .88 | 3.67 ± .99 |
| 6-Month Follow-Up | 3.81 ± .94 | 3.73 ± 1.0 |
| 12-Month Follow-Up | 3.75 ± .96 | 3.81 ± .98 |
Scores on the Approach Coping sub-scale of the Pain Coping Questionnaire were used to measure approach coping, which is a type of coping considered to be adaptive and helpful for pain. Responses to items on this subscale are on a 5-point scale ("never use" to "very often use") and are averaged together for the subscale score, such that scores range from a worst possible value of 1 to a best possible value of 5.
| units on a scale | Web-based Coping Skills Training | Online Disease Education Control |
|---|---|---|
| Baseline | 2.63 ± .75 | 2.57 ± .73 |
| Post-Treatment | 2.84 ± .87 | 2.67 ± .88 |
| 6-Month Follow-Up | 2.76 ± .90 | 2.55 ± .87 |
| 12-Month Follow-Up | 2.71 ± 1.03 | 2.55 ± .88 |
Collected over Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Web-based Coping Skills Training | — | 4/144 (2.8%) | 38/144 (26.4%) |
| Online Disease Education Control | — | 5/145 (3.4%) | 34/145 (23.4%) |
| Event | Web-based Coping Skills Training | Online Disease Education Control |
|---|---|---|
| HospitalizationGastrointestinal disorders | 1/144 | 3/145 |
| Arthritis flareMusculoskeletal and connective tissue disorders | 1/144 | 0/145 |
| Hospitalized for management of Crohn's disease flareImmune system disorders | 1/144 | 0/145 |
| Hospitalized for suicidal thoughtsPsychiatric disorders | 1/144 | 0/145 |
| Hospitalized for macrophage activation syndromeInfections and infestations | 0/144 | 1/145 |
| Hospitalized for appendicitisInfections and infestations | 0/144 | 1/145 |
| Event | Web-based Coping Skills Training | Online Disease Education Control |
|---|---|---|
| Arthritis flareImmune system disorders | 13/144 | 4/145 |
| InfectionInfections and infestations | 7/144 | 11/145 |
| Abdominal painGastrointestinal disorders | 1/144 | 7/145 |
| Skin system findings (psoriasis, rash)Skin and subcutaneous tissue disorders | 5/144 | 3/145 |
| Blood disorder/problemsBlood and lymphatic system disorders | 3/144 | 2/145 |
| DepressionPsychiatric disorders | 3/144 | 1/145 |
| Injury (e.g., sprain, fracture)Injury, poisoning and procedural complications | 2/144 | 3/145 |
| Dizziness and/or fatigueNervous system disorders | 2/144 | 2/145 |
| Suicidal thoughtsPsychiatric disorders | 2/144 | 1/145 |
| Age, Continuous(years) | Web-based Coping Skills Training | Online Disease Education Control | Never Randomized | Total |
|---|---|---|---|---|
| Mean | 14.65 ± 1.85 | 14.55 ± 1.76 | 15.06 ± 1.69 | 14.59 ± 1.79 |
| Sex: Female, Male(Participants) | Web-based Coping Skills Training | Online Disease Education Control | Never Randomized | Total |
|---|---|---|---|---|
| Female | 98 | 111 | 13 | 222 |
| Male | 46 | 34 | 3 | 83 |
| Ethnicity (NIH/OMB)(Participants) | Web-based Coping Skills Training | Online Disease Education Control | Never Randomized | Total |
|---|---|---|---|---|
| Hispanic or Latino | 21 | 17 | 1 | 39 |
| Not Hispanic or Latino | 123 | 128 | 15 | 266 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Web-based Coping Skills Training | Online Disease Education Control | Never Randomized | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 3 | 0 | 0 | 3 |
| Asian | 5 | 5 | 0 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 0 | 2 |
| Black or African American | 7 | 5 | 1 | 13 |
| White | 120 | 123 | 13 | 256 |
| More than one race | 9 | 10 | 2 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
Plan to share: Yes — A deidentified dataset is available for secondary analyses per our Resource Sharing Plan.
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Children's Mercy Hospital Kansas City