Internet Self-Management Program With Telephone Support for Adolescents With Arthritis

Study Overview
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Brief Summary
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This study will evaluate the feasibility of Teens Taking Charge: Managing Arthritis On-line intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL).

Detailed Description
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This feasibility study will (1) assess adolescents' willingness to be randomized; (2) pilot the intervention, attention control strategies (e.g., adolescents' 'own best efforts' at managing arthritis), and outcome measures; (3) determine adolescents' perceptions regarding acceptability of the web-based intervention; and (4) obtain estimates of treatment effects in primary (HRQL) and secondary (knowledge, coping, self-efficacy, stress, treatment adherence, pain) outcome measures to inform the calculation of appropriate sample size for the future RCT. We hypothesize that adolescents with JIA in the web-based intervention will demonstrate: (a) improved HRQL; (b) increased disease-specific knowledge; (c) improved coping, self-efficacy, and adherence to prescribed management; and (d) decreased pain and stress compared to adolescents in the attention control group

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

Conditions
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Juvenile Idiopathic Arthritis

Intervention / Treatment
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* Behavioral: Teens Taking Charge
* Behavioral: Self-Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adolescents 12 to 18 years diagnosed with JIA, able to speak and read English or French able to complete baseline online outcome measures. Exclusion Criteria: cognitive impairment major co-morbid illnesses (medical or psychiatric) which may impact their ability to understand and use the web-based program.

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: Internet-based JIA Self-Management Program<br> | Behavioral: Teens Taking Charge<br>* The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.<br>|
| Active Comparator: Attention Control Group<br> | Behavioral: Self-Management<br>* Adolescents' own best efforts at managing their JIA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Juvenile Arthritis Quality of Life Questionnaire (JAQQ) | The questionnaire is divided into 4 dimensions: gross motor function, fine motor function, psychosocial function, and general symptoms. A 7-point ordinal scale is used to rate responses to each item from 1 (none of the time) to 7 (all of the time), based on how often the item was a problem for the child over the past 2 weeks. Total score was composed of the 4 dimension scores (top 5 items of that dimension) divided by 4, with higher scores denoting poorer HRQOL. | Baseline (prior to randomization) and 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Issues Sub-Scale From Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS) | Measure looks at disease specific knowledge. Subscale used: Medical Issues Subscale scores range from 0 (min) - 10 (max) with higher scores indicating greater knowledge. | 3 months after intervention | 
| Pain Coping (Pain Coping Questionnaire) |  | Baseline (prior to randomization) and 3 months after intervention | 
| Children's Arthritis Self-Efficacy Scale (CASE) | Measure looks at Self-efficacy. Subscales: Activity, Emotion, Family. Subscale scores range 0 - 10 with higher scores indicating greater self-efficacy. | 3 months after intervention | 
| Child Adherence Report Questionnaire (CARQ) | Measure examines adherence to treatment. Subscales: Treatment Adherence to: Medication, Exercise, Splints. Subscale scores rage 0 - 10 with higher scores indicate better overall child ability in relation to following treatment recommendations. | 3 months after intervention | 
| Perceived Stress Questionnaire (PSQ) | Measure examines stress. Total score calculated was an average of all items with a range from 1-4 with higher scores indicating greater stress. | 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Teens Taking Charge, Managing Arthritis Online, juvenile idiopathic arthritis, internet, self-management