An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 13
- 主要终点
- Pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Jennifer Stinson
Clinician Scientist, Clinical Nurse Specialist/NP
The Hospital for Sick Children