Juvenile Idiopathic ArthritisPhase 3WebSMARTNCT01541917
Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
A Phase 3 study testing Web-based coping skills training and Online disease education in people with Juvenile Idiopathic Arthritis, run by Children's Mercy Hospital Kansas City at 10 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Web-based coping skills training and Online disease education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2012to Jun 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12-18 years of age (inclusive)
- diagnosed with JIA by a pediatric rheumatologist
- able to speak and read English and/or Spanish
- able to complete online measures
- reporting pain in at least one joint over the past 6 months
Who cannot join
- have another chronic medical condition that adversely impacts pain and/or health-related quality of life (e.g., inflammatory bowel disease, fibromyalgia, cancer, genetic disorder, pervasive developmental disorder, diabetes)
- have a significant cognitive impairment or illiteracy that would prevent understanding of the intervention and outcome measures
- currently in psychotherapy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Lurie Children's Hospital
Chicago, Illinois, 60614-3363
Nationwide Children's Hospital
Columbus, Ohio, 43205
Duke University Medical Center
Durham, North Carolina, 27705
Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, 07601
Riley Hospital for Children
Indianopolis, Indiana, 46202
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
The Children's Hospital at Legacy Emmanuel Medical Center
Portland, Oregon, 97227
University of California San Francisco Benioff Children's Hospital
San Francisco, California, 94143
Seattle Children's Hospital
Seattle, Washington, 98133
About this study
Official title: WebSMART: Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
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.
Read the detailed description
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.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Web-based coping skills training, Online disease education
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based coping skills trainingBehavioural
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based coping skills training | Experimental | 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. Receives: Behavioral: Web-based coping skills training |
| Online disease education | Active comparator | Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks. Receives: Behavioral: Online disease education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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.
Measured: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Mark A Connelly, PhD, Principal investigator, Children's Mercy Hospital Kansas CityJennifer Stinson, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541917
- Sponsor's protocol ID
- GRANT10829275
- Other IDs
- 1R01AR061513-01
- Acronym
- WebSMART
- Status last verified
- Jan 2017
- First submitted
- 24 Feb 2012
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: A deidentified dataset is available for secondary analyses per our Resource Sharing Plan.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WebSMART: Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT01541917
- Acronym / sponsor ID
- WebSMART / GRANT10829275
- Conditions
- Juvenile Idiopathic Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jul 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based coping skills training | Experimental | Behavioral: Web-based coping skills trainingInvolves 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. |
| Online disease education | Active comparator | Behavioral: Online disease educationInvolves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 12-18 years of age (inclusive)
- diagnosed with JIA by a pediatric rheumatologist
- able to speak and read English and/or Spanish
- able to complete online measures
- reporting pain in at least one joint over the past 6 months
Key exclusion criteria (3 listed)
- have another chronic medical condition that adversely impacts pain and/or health-related quality of life (e.g., inflammatory bowel disease, fibromyalgia, cancer, genetic disorder, pervasive developmental disorder, diabetes)
- have a significant cognitive impairment or illiteracy that would prevent understanding of the intervention and outcome measures
- currently in psychotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based coping skills trainingThis 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. | Behavioural | Web-based coping skills training |
| Online disease educationThe 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. | Behavioural | Online disease education |
Primary outcome
Change in Pain Intensity
Time frame: Baseline, post-treatment, 6-month follow-up, 12-month follow-up
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").
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
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.
4 secondary outcomes
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
Change in Disease Activity
Time frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Change in Children's Arthritis Self-Efficacy (CASE) Scores
Time frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Change in Approach Coping
Time frame: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A deidentified dataset is available for secondary analyses per our Resource Sharing Plan.
Related trials for Juvenile Idiopathic Arthritis
RecruitingPhase 3
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Recruiting
The Use of Infrared Cameras for Detecting Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis, Infrared Thermography
Not yet recruitingPhase 4
Withdrawal Versus Continued TNF Inhibitor Monotherapy Treatment in Children With Inactive Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingObservational study
Tofacitinib in Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingPhase 3
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Connelly, PhD principal investigator
Children's Mercy Hospital Kansas City
Jennifer Stinson, PhD principal investigator
The Hospital for Sick Children
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Web-based coping skills training and Online disease education in people with Juvenile Idiopathic Arthritis, run by Children's Mercy Hospital Kansas City at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Baseline, post-treatment, 6-month follow-up, 12-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.