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Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis (WebSMART)

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ClinicalTrials.gov Identifier: NCT01541917
Recruitment Status : Completed
First Posted : March 1, 2012
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Juvenile Idiopathic Arthritis
Interventions Behavioral: Web-based coping skills training
Behavioral: Online disease education
Enrollment 305
Recruitment Details  
Pre-assignment Details For this trial, 305 patients consented (were enrolled) to participate, but 7 of these patients subsequently were found to not fully meet eligibility criteria and 9 of these patients dropped out prior to being randomized. The total randomized sample therefore is 289.
Arm/Group Title Web-based Coping Skills Training Online Disease Education Control
Hide Arm/Group Description

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.

Web-based coping skills training: 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.

Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.

Online disease education: 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.

Period Title: Overall Study
Started 144 145
Completed 129 136
Not Completed 15 9
Reason Not Completed
Lost to Follow-up             2             2
Withdrawal by Subject             13             7
Arm/Group Title Web-based Coping Skills Training Online Disease Education Control Never Randomized Total
Hide Arm/Group Description 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 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 health coach to discuss the participant's efforts at managing his/her disease. This group comprises participants that consented but were never randomized to a condition due to being determined to not meet eligibility criteria or self-withdrawing before randomization. Total of all reporting groups
Overall Number of Baseline Participants 144 145 16 305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 144 participants 145 participants 16 participants 305 participants
14.65  (1.85) 14.55  (1.76) 15.06  (1.69) 14.59  (1.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants 145 participants 16 participants 305 participants
Female
98
  68.1%
111
  76.6%
13
  81.3%
222
  72.8%
Male
46
  31.9%
34
  23.4%
3
  18.8%
83
  27.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants 145 participants 16 participants 305 participants
Hispanic or Latino
21
  14.6%
17
  11.7%
1
   6.3%
39
  12.8%
Not Hispanic or Latino
123
  85.4%
128
  88.3%
15
  93.8%
266
  87.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants 145 participants 16 participants 305 participants
American Indian or Alaska Native
3
   2.1%
0
   0.0%
0
   0.0%
3
   1.0%
Asian
5
   3.5%
5
   3.4%
0
   0.0%
10
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   1.4%
0
   0.0%
2
   0.7%
Black or African American
7
   4.9%
5
   3.4%
1
   6.3%
13
   4.3%
White
120
  83.3%
123
  84.8%
13
  81.3%
256
  83.9%
More than one race
9
   6.3%
10
   6.9%
2
  12.5%
21
   6.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in Pain Intensity
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were analyzed regardless of whether or not they completed treatment (intent to treat analyses).
Arm/Group Title Web-based Coping Skills Training Online Disease Education Control
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 144 145
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education Control
Comments Multilevel growth model evaluating average change over time (regardless of group) on the outcome variable
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Slope
Estimated Value -.04
Confidence Interval (2-Sided) 95%
-.06 to -.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: .01
Estimation Comments The parameter represents the average monthly change on the outcome variable since group procedures were initiated.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education Control
Comments Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .51
Comments [Not Specified]
Method Multilevel growth model
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -.014
Confidence Interval (2-Sided) 95%
-.055 to .027
Parameter Dispersion
Type: Standard Error of the Mean
Value: .021
Estimation Comments The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).
2.Primary Outcome
Title Change in PedsQL Rheumatology Health-Related Quality of Life Total Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Web-based Coping Skills Training Online Disease Education
Hide Arm/Group Description:

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.

Web-based coping skills training: 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.

Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.

Online disease education: 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.

Overall Number of Participants Analyzed 144 145
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education
Comments Multilevel growth model evaluating average change over time on the outcome variable
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values.
Method of Estimation Estimation Parameter Slope
Estimated Value .37
Confidence Interval (2-Sided) 95%
.27 to .46
Parameter Dispersion
Type: Standard Error of the Mean
Value: .05
Estimation Comments The parameter represents the average monthly change on the outcome variable since before group procedures were started.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education
Comments Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .59
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values on the outcome variable
Method of Estimation Estimation Parameter Slope
Estimated Value .053
Confidence Interval (2-Sided) 95%
-.144 to .252
Parameter Dispersion
Type: Standard Error of the Mean
Value: .101
Estimation Comments The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).
3.Secondary Outcome
Title Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Web-based Coping Skills Training Online Disease Education
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 144 145
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education
Comments Multilevel growth model evaluating average change over time on the outcome variable
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Slope
Estimated Value .12
Confidence Interval (2-Sided) 95%
.10 to .14
Parameter Dispersion
Type: Standard Error of the Mean
Value: .01
Estimation Comments The parameter represents the average monthly change on the outcome variable since before group procedures were started
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education
Comments Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .63
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values on the outcome variable
Method of Estimation Estimation Parameter Slope
Estimated Value -.01
Confidence Interval (2-Sided) 95%
-.05 to .03
Parameter Dispersion
Type: Standard Error of the Mean
Value: .02
Estimation Comments The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).
4.Secondary Outcome
Title Change in Disease Activity
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Web-based Coping Skills Training Online Disease Education Control
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 144 145
Mean (Standard Deviation)
Unit of Measure: joints
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education Control
Comments Multilevel growth model evaluating average change over time on the outcome variable
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Slope
Estimated Value -.10
Confidence Interval (2-Sided) 95%
-.18 to -.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: .04
Estimation Comments The parameter represents the average monthly change on the outcome variable since before group procedures were started.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education Control
Comments Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .91
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values on the outcome variable
Method of Estimation Estimation Parameter Slope
Estimated Value -.009
Confidence Interval (2-Sided) 95%
-.174 to .155
Parameter Dispersion
Type: Standard Error of the Mean
Value: .084
Estimation Comments The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).
5.Secondary Outcome
Title Change in Children’s Arthritis Self-Efficacy (CASE) Scores
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Web-based Coping Skills Training Online Disease Education Control
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 144 145
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education Control
Comments Multilevel growth model evaluating average change over time on the outcome variable
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values.
Method of Estimation Estimation Parameter Slope
Estimated Value .0316
Confidence Interval (2-Sided) 95%
.02 to .04
Parameter Dispersion
Type: Standard Error of the Mean
Value: .004
Estimation Comments The parameter represents the average monthly change on the outcome variable since before group procedures were started
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education Control
Comments Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .67
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values on the outcome variable
Method of Estimation Estimation Parameter Slope
Estimated Value -.004
Confidence Interval (2-Sided) 95%
-.02 to .013
Parameter Dispersion
Type: Standard Error of the Mean
Value: .008
Estimation Comments The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).
6.Secondary Outcome
Title Change in Approach Coping
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Web-based Coping Skills Training Online Disease Education Control
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 144 145
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education Control
Comments Multilevel growth model evaluating average change over time on the outcome variable
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .58
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Slope
Estimated Value -.002
Confidence Interval (2-Sided) 95%
-.01 to .01
Parameter Dispersion
Type: Standard Error of the Mean
Value: .004
Estimation Comments The parameter represents the average monthly change on the outcome variable since before group procedures were started.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Web-based Coping Skills Training, Online Disease Education Control
Comments Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .49
Comments [Not Specified]
Method Multilevel growth model
Comments Adjusted for baseline values on the outcome variable
Method of Estimation Estimation Parameter Slope
Estimated Value .005
Confidence Interval (2-Sided) 95%
-.009 to .018
Parameter Dispersion
Type: Standard Error of the Mean
Value: .007
Estimation Comments The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).
Time Frame Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Adverse Event Reporting Description Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
 
Arm/Group Title Web-based Coping Skills Training Online Disease Education Control
Hide Arm/Group Description 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.
All-Cause Mortality
Web-based Coping Skills Training Online Disease Education Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Web-based Coping Skills Training Online Disease Education Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/144 (2.78%)      5/145 (3.45%)    
Gastrointestinal disorders     
Hospitalization  [1]  1/144 (0.69%)  1 3/145 (2.07%)  4
Immune system disorders     
Hospitalized for management of Crohn's disease flare   1/144 (0.69%)  1 0/145 (0.00%)  0
Infections and infestations     
Hospitalized for macrophage activation syndrome   0/144 (0.00%)  0 1/145 (0.69%)  1
Hospitalized for appendicitis   0/144 (0.00%)  0 1/145 (0.69%)  1
Musculoskeletal and connective tissue disorders     
Arthritis flare  [2]  1/144 (0.69%)  1 0/145 (0.00%)  0
Psychiatric disorders     
Hospitalized for suicidal thoughts   1/144 (0.69%)  1 0/145 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Hospitalized for evaluation of abdominal pain.
[2]
Admitted to hospital for management of arthritis flare
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Web-based Coping Skills Training Online Disease Education Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/144 (26.39%)      34/145 (23.45%)    
Blood and lymphatic system disorders     
Blood disorder/problems   3/144 (2.08%)  3 2/145 (1.38%)  2
Gastrointestinal disorders     
Abdominal pain   1/144 (0.69%)  1 7/145 (4.83%)  8
Immune system disorders     
Arthritis flare   13/144 (9.03%)  18 4/145 (2.76%)  4
Infections and infestations     
Infection   7/144 (4.86%)  7 11/145 (7.59%)  11
Injury, poisoning and procedural complications     
Injury (e.g., sprain, fracture)   2/144 (1.39%)  2 3/145 (2.07%)  3
Nervous system disorders     
Dizziness and/or fatigue   2/144 (1.39%)  2 2/145 (1.38%)  2
Psychiatric disorders     
Depression   3/144 (2.08%)  3 1/145 (0.69%)  1
Suicidal thoughts   2/144 (1.39%)  2 1/145 (0.69%)  1
Skin and subcutaneous tissue disorders     
Skin system findings (psoriasis, rash)   5/144 (3.47%)  6 3/145 (2.07%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mark Connelly, PhD (Principal Investigator)
Organization: Children's Mercy Hospital
Phone: 816-234-3000 ext 3193
Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01541917     History of Changes
Other Study ID Numbers: GRANT10829275
1R01AR061513-01 ( U.S. NIH Grant/Contract )
First Submitted: February 24, 2012
First Posted: March 1, 2012
Results First Submitted: November 21, 2016
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017