iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Participant accrual rate
研究概览
简要总结
This study will look at the use and impact of smartphone application (app) for adolescents with ongoing pain caused by their juvenile idiopathic arthritis (JIA).The current project will include three studies. First, the investigators conducted usability sessions with adolescents with JIA to refine the app so that it is usable, acceptable and understandable. The aim of this study is to look at (a) how regularly the "iCanCope with Pain" app is used and (b) any effect the app has on young people's health. This study will compare two groups of young people: one that is using the new app, and one that receives usual medical care.
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
- •Aged 12-18 years
- •Diagnosed with JIA (36) as per their rheumatologist
- •Able to speak and read English
- •Have self-reported average arthritis-related pain in the past week of >3 on 10cm visual analogue scale (VAS)
- •Willing to complete online study outcome measures
排除标准
- •Moderate to severe cognitive impairments as per their healthcare provider
- •Major co-morbid psychiatric [conversion disorder, depression, anxiety disorder] illnesses that may impact their ability to understand and use the "iCanCope with Pain" intervention as per their rheumatologist
- •Received more than 4 CBT sessions for pain management in the past 6 months, as per their healthcare provider and self-report
- •Patients from the department of haematology/oncology
研究组 & 干预措施
iCanCope app
iCanCope app
干预措施: iCanCope app (Behavioral)
Attention control app
Control group: iCanCope attention control app
干预措施: iCanCope attention control app (Behavioral)
结局指标
主要结局
Participant accrual rate
时间窗: 8 weeks
Centrally tracked by the clinical research project coordinator
Number of issues or difficulties in implementing the intervention
时间窗: 8 weeks
The intervention fidelity log will track any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC.
Acceptability of intervention
时间窗: 8 weeks
Participants in the intervention arm will complete the Acceptability e-scale (AES) post-intervention. In addition, a subset of participants from the intervention group will be offered to participate in a qualitative feedback interview to further explore acceptability of the intervention.
Frequency of login per user
时间窗: 8 weeks
Measured through the iCanCope server.
Adherence
时间窗: 8 weeks
Adherence will be determined using Google Analytics.
Adverse Events
时间窗: 8 weeks
Adverse events will be tracked using an adverse event form
Participant dropout rate
时间窗: 8 weeks
Centrally tracked by clinical research project coordinator
Satisfaction of intervention
时间窗: 8 weeks
A subset of participants from the intervention group will be offered to participate in a qualitative feedback interview to further explore satisfaction of the intervention.
次要结局
- Health-Related Quality of Life (HRQoL)(8 weeks)
- Pain(8 weeks)
- Pain-Related Activity Limitations(8 weeks)
- Pain coping(8 weeks)
- Health care utilization form(8 weeks)
- Health Utility Index(8 weeks)
研究者
Jennifer Stinson
Clinician Scientist, Clinical Nurse Specialist/NP
The Hospital for Sick Children