An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthritis, Juvenile Idiopathic
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 333
- Locations
- 11
- Primary Endpoint
- Pain
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Jennifer Stinson
Clinician Scientist, Clinical Nurse Specialist/NP
The Hospital for Sick Children
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Pain
Time Frame: 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)
Time Frame: 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 Outcomes
- Emotional Symptoms(Baseline, 3 months, 6 months and 12 months post-intervention)
- Self-Efficacy(Baseline, 3 months, 6 months and 12 months post-intervention)
- Adherence(Baseline, 3 months, 6 months and 12 months post-intervention)
- Pain Coping(Baseline, 3 months, 6 months and 12 months post-intervention)
- Juvenile Idiopathic Arthritis (JIA)(Baseline, 3 months, 6 months and 12 months post-intervention)