An Internet-based Self-management Program With Telephone Support for Adolescents With Arthritis: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
研究概览
简要总结
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).
详细描述
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
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 (Outcomes Assessor)
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
- •adolescents 12 to 18 years
- •diagnosed with JIA,
- •able to speak and read English or French
- •able to complete baseline online outcome measures.
排除标准
- •cognitive impairment
- •major co-morbid illnesses (medical or psychiatric) which may impact their ability to understand and use the web-based program.
结局指标
主要结局
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
时间窗: Baseline (prior to randomization) and 3 months after intervention
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.
次要结局
- Pain Coping (Pain Coping Questionnaire)(Baseline (prior to randomization) and 3 months after intervention)
- Children's Arthritis Self-Efficacy Scale (CASE)(3 months after intervention)
- Medical Issues Sub-Scale From Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS)(3 months after intervention)
- Child Adherence Report Questionnaire (CARQ)(3 months after intervention)
- Perceived Stress Questionnaire (PSQ)(3 months after intervention)
研究者
Jennifer Stinson
Scientist
The Hospital for Sick Children