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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Web-based Coping Skills Training

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.

Online Disease Education Control

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.


Participant Flow:   Overall Study
    Web-based Coping Skills Training   Online Disease Education Control
STARTED   144   145 
COMPLETED   129   136 
NOT COMPLETED   15   9 
Lost to Follow-up                2                2 
Withdrawal by Subject                13                7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 to review material and help enhance motivation.
Online Disease Education Control 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.
Never Randomized 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 Total of all reporting groups

Baseline Measures
   Web-based Coping Skills Training   Online Disease Education Control   Never Randomized   Total 
Overall Participants Analyzed 
[Units: Participants]
 144   145   16   305 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.65  (1.85)   14.55  (1.76)   15.06  (1.69)   14.59  (1.79) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Change in Pain Intensity   [ Time Frame: Baseline, post-treatment, 6-month follow-up, 12-month follow-up ]

2.  Primary:   Change in PedsQL Rheumatology Health-Related Quality of Life Total Score   [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ]

3.  Secondary:   Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score   [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ]

4.  Secondary:   Change in Disease Activity   [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ]

5.  Secondary:   Change in Children’s Arthritis Self-Efficacy (CASE) Scores   [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ]

6.  Secondary:   Change in Approach Coping   [ Time Frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: mconnelly1@cmh.edu



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