An Internet-based Self-management Program for Adolescents With Arthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial

Conditions
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Arthritis, Juvenile Idiopathic

Intervention / Treatment
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* Behavioral: Taking Charge: Managing JIA Online
* Behavioral: Standard Medical Care and JIA Resource Center


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Adolescents that are currently participating in other CBT interventions.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taking Charge Experimental Group<br> | Behavioral: Taking Charge: Managing JIA Online<br>* In addition to standard medical care, adolescents in the experimental group will receive the Taking Charge: Managing JIA Online Internet self-management program. The intervention is a 12-module interactive multi-component treatment protocol - that consists of JIA-specific education, self-management strategies, and social support - that is available in English and French.<br>|
| Active Comparator: Control Group<br> | Behavioral: Standard Medical Care and JIA Resource Center<br>* The control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention and through the 9-month follow-up period. In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about JIA (JIA Resource Centre) and online assessments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | 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 | 12 months | 
| Health-related Quality of Life (HRQL) | 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. | Baseline | 
| Pain | 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 | Baseline | 
| Pain | 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 | 3months | 
| Health-related Quality of Life (HRQL) | 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. | 6 months | 
| Pain | 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 | 6 months | 
| Health-related Quality of Life (HRQL) | 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. | 3 months | 
| Health-related Quality of Life (HRQL) | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional Symptoms | Anxiety and depression will each be assessed using two, separate 8-item PROMIS (Patient Reported Outcomes Measurement Information System) scales. | Baseline, 3 months, 6 months and 12 months post-intervention | 
| Adherence | Adherence to medical treatment will be assessed using the 34-item Child Adherence Report Questionnaire (CARQ) | Baseline, 3 months, 6 months and 12 months post-intervention | 
| Pain Coping | 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. | Baseline, 3 months, 6 months and 12 months post-intervention | 
| Juvenile Idiopathic Arthritis (JIA) | JIA-specific knowledge will be measured using 9-items from the Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS). | Baseline, 3 months, 6 months and 12 months post-intervention | 
| Self-Efficacy | Self-efficacy will be measured using the Children's Arthritis Self-Efficacy (CASE) scale which is an 11-item measure. | Baseline, 3 months, 6 months and 12 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adoloescent, internet self-management, managing JIA