iCanCope With Pain: An Integrated Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 14
- 主要终点
- Intervention fidelity
研究概览
简要总结
Chronic pain in adolescents and young adults (AYA, aged 15-25) is a common problem. Pain that is not treated properly can reduce quality of life. Programs to help AYA learn to live with and manage pain are very important. Our team is developing a smartphone application (app) and website for AYA with chronic pain. The app will help AYA to track pain, sleep, mood, activities, and exercise and help AYA set and achieve goals. The website will give information about pain and how to manage it independently. We will build the program and make sure it is easy to use and understand. We will also test if the program can be put into practice as planned and if AYA using the program feel less pain, have less limitations, and a better quality of life.
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
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic pain of at least 3 months duration according to medical chart
- •Able to speak and read English
- •Willing and able to complete online measures
- •Participants are active patients at pain clinic at one of the respective participating study sites
- •Have been on a stable dose of medications for at least 4 weeks prior to entering the study according to medical chart
- •Have access to an Internet-connected computer according to self-report.
排除标准
- •Moderate to severe cognitive impairments, as assessed by reviewing medical chart and consultation with the patient's healthcare provider
- •Major co-morbid psychiatric (e.g. conversion disorder, depression, anxiety disorder) illness that may impact patient's ability to understand and use the iCanCope with Pain intervention via self-report, as determined by their health care provider
- •Patient from the department of haemology/oncology
- •Participated in the Phase 2B iCanCope usability study
研究组 & 干预措施
iCanCope app and website
Intervention: Behavioral: iCanCope app and website
干预措施: iCanCope app and website (Behavioral)
Attention control group
Intervention: Behavioral: Attention control group
干预措施: Attention control group (Behavioral)
结局指标
主要结局
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.
Acceptability and Satisfaction
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 and satisfaction of the intervention.
Engagement with Intervention
时间窗: 8 weeks
Google Analytics will track patterns of app and website usage.
Adherence
时间窗: 8 weeks
Adherence will be determined using Google Analytics.
Participant Accrual and Dropout Rates
时间窗: 8 weeks
This will be centrally tracked by the clinical research project coordinator (CRPC).
Participant Accrual and Dropout Rates
时间窗: 6 months
This will be centrally tracked by the clinical research project coordinator (CRPC).
次要结局
- Pain intensity and interference(8 weeks)
- Self-efficacy(8 weeks)
- Emotional Functioning(8 weeks)
- Sleep Functioning(8 weeks)
- Social Functioning(8 weeks)
- Pain-Related Knowledge(8 weeks)
- Patients' Global Impression of Change(8 weeks)
- Health-Related Quality of Life(8 weeks)
- Health Care Utilization(8 weeks)
- Adverse effects(8 weeks)
- Pain intensity and interference(6 months)
- Self-efficacy(6 months)
- Emotional Functioning(6 months)
- Sleep Functioning(6 months)
- Social Functioning(6 months)
- Health-Related Quality of Life(6 months)
- Patients' Global Impression of Change(6 months)
- Pain-Related Knowledge(6 months)
- Health Care Utilization(6 months)
- Adverse effects(6 months)
研究者
Jennifer Stinson
Clinician Scientist, Clinical Nurse Specialist/NP
The Hospital for Sick Children