Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With Juvenile Idiopathic Arthritis (JIA) and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 7
- 主要终点
- Dropout Rates
研究概览
简要总结
Arthritis in children is a long-term illness and it can make a child's life very difficult. In children 8-11 years old, the child and their family work together to deal with the problems that arthritis can cause. Learning to cope with and manage the problems that come with arthritis can stop it from getting worse. It is important to create programs that teach children and families how to cope with and manage arthritis. This study will develop and test an online game that helps children learn how to better manage their arthritis. The goal of these studies is to test: (1) how easy to use and acceptable the online game is; and (2) if children who play the game feel less pain, have fewer limitations, and a better quality of life compared to children who do not play the game.
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 (Investigator)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 8 and ≤ 11 years of age
- •Diagnosed with JIA (minimum 3 months) using International League of Associations for Rheumatology classification criteria96
- •Active disease
- •Child and primary parent/caregiver are able to speak and read English or French
- •Participants are willing and able to complete online measures
排除标准
- •Cognitive impairments (as assessed by reviewing medical chart and consultation with the patient's rheumatologist)
- •Major co-morbid illnesses (e.g., medical [inflammatory bowel disease, cancer, diabetes] or psychiatric [depression, anxiety]) which may impact their ability to understand and use the game or complete outcome assessments (as determined by their rheumatologist).
- •Children currently participating in other Cognitive Behavioural Therapy (CBT) interventions
- •Usability testing participants
研究组 & 干预措施
Usual Care
Control group.
干预措施: Usual Care (Other)
Game
Access to the game.
干预措施: Game (Behavioral)
结局指标
主要结局
Dropout Rates
时间窗: 8 weeks
This will be centrally tracked by the clinical research project coordinator (CRPC).
Participant Accrual
时间窗: 8 weeks
This will be centrally tracked by the clinical research project coordinator (CRPC).
Intervention Fidelity
时间窗: 8 weeks
Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC. For example, issues from a technical standpoint (for example, game not downloading properly, participant requiring assistance using the technology) or logistics standpoint.
Acceptability and Satisfaction with Intervention
时间窗: 8 weeks
Immediately post-trial children and parents in the intervention group will rate their acceptability of and satisfaction with the game and 10-15 English and 10-15 French children and one of their parents will take part in a brief qualitative interview.
Engagement with Intervention
时间窗: 8 weeks
Analytics will be used to track patterns of website program usage ("number of interactions" \[clicks\]).
次要结局
- Pain(8 weeks)
- Pain-related Activity Limitations(8 weeks)
- Health-related Quality of Life(8 weeks)
- Self Efficacy(8 weeks)
- JIA-specific Disease Knowledge(8 weeks)
- Adherence(8 weeks)
研究者
Jennifer Stinson
Clinician Scientist/Clinical Nurse Specialist/NP
The Hospital for Sick Children