An Internet-based Self-management Program for Adolescents With Arthritis
- Conditions
- Arthritis, Juvenile Idiopathic
- Interventions
- Behavioral: Standard Medical Care and JIA Resource Center
- Registration Number
- NCT01572896
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
The purpose of this study is to demonstrate the effectiveness of the "Taking Charge: Managing JIA Online" Internet intervention, when compared with an attention (static education only websites) control group in improving pain and HRQL as well as other health outcomes (anxiety, depression, treatment adherence, pain coping, knowledge, and self-efficacy) in adolescents with JIA. The proposed study will enroll and randomize 294 adolescents with JIA attending 10 pediatric rheumatology hospital clinics in the Canada to either the experimental or control groups.
- Detailed Description
In summary, no rigorous Internet self-management intervention has been undertaken to improve HRQL, symptoms, treatment adherence, knowledge, and self-efficacy in youth with JIA. The proposed "Managing JIA Online" Trial will rigorously examine the effects of this Internet intervention on HRQL and other health outcomes thereby filling a significant gap in our knowledge related to promotion of self-management care for adolescents with JIA.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
- Age ≥12 and ≤ 18 years.
- Diagnosed with JIA (using International League of Associations for Rheumatology classification criteria)83 by their rheumatologist.
- Adolescents and parent/ primary caregiver are able to speak and read either English or French.
- Participants are willing and able to complete online measures. There will be no restrictions on medication use for this study.
-
Cognitive impairments (as assessed by reviewing medical chart and consultation with the patient's rheumatologist)
-
Major co-morbid illnesses which may mitigate HRQL assessment
- Excluded medical illnesses: inflammatory bowel disease, fibromyalgia, cancer, genetic disorders, diabetes
- Excluded psychiatric conditions: post-traumatic stress disorder, panic disorder, bipolar disorder, psychosis, depression and major mood disorders. Adolescents currently on medications for major depression, bipolar disorder or psychosis would also be excluded.
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Adolescents that are currently participating in other CBT interventions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Standard Medical Care and JIA Resource Center -
- Primary Outcome Measures
Name Time Method Pain 6 months Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
Health-related Quality of Life (HRQL) 12 months HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
- Secondary Outcome Measures
Name Time Method Emotional Symptoms Baseline, 3 months, 6 months and 12 months post-intervention Anxiety and depression will each be assessed using two, separate 8-item PROMIS (Patient Reported Outcomes Measurement Information System) scales.
Self-Efficacy Baseline, 3 months, 6 months and 12 months post-intervention Self-efficacy will be measured using the Children's Arthritis Self-Efficacy (CASE) scale which is an 11-item measure.
Adherence Baseline, 3 months, 6 months and 12 months post-intervention Adherence to medical treatment will be assessed using the 34-item Child Adherence Report Questionnaire (CARQ)
Pain Coping Baseline, 3 months, 6 months and 12 months post-intervention Pain coping will be measured using the 18-item Pain Coping Questionnaire106, which is an internationally used measure of pain coping strategies in the pediatric population and has been validated in youth with arthritis.
Juvenile Idiopathic Arthritis (JIA) Baseline, 3 months, 6 months and 12 months post-intervention JIA-specific knowledge will be measured using 9-items from the Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS).
Trial Locations
- Locations (11)
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Alberta Children's Hospital
🇨🇦Calgary, Canada
Stollery Children's Hospital
🇨🇦Edmonton, Canada
Montreal Children's Hospital
🇨🇦Montreal, Canada
IWK Health Centre
🇨🇦Halifax, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Canada
Royal University
🇨🇦Saskatoon, Canada
Janeway Children's Health and Rehabilitation Centre
🇨🇦St. Johns, Canada
Winnepeg Children's Hospital
🇨🇦Winnepeg, Canada
BC Children's Hospital
🇨🇦Vancouver, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada