iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 7
- 主要终点
- Pain Diary - Average Daily Activity Limitations
研究概览
简要总结
The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.
详细描述
Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. However, most people with SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. First, the investigators plan to apply a user-centered design approach to develop and refine the iCanCope with SCD program. Second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. The investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. Preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. Third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. These results will enable a future full-scale randomized controlled trial.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •aged between 12-18 years
- •diagnosed with any type of SCD
- •able to speak and read English
- •score at least 4 (indicating some days with pain interference over the past month) on the Sickle Cell Pain Burden Interview
- •willing and able to complete online measures
排除标准
- •significant cognitive limitations that would impair their ability to use and understand the iCanCope with SCD program, as per their healthcare provider or parent
- •have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.
结局指标
主要结局
Pain Diary - Average Daily Activity Limitations
时间窗: Baseline,12 weeks, and 26 weeks
App diary using Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days Scores range from 0-100 where higher scores mean a worse outcome
Pain Diary - Average Daily Pain
时间窗: Baseline,12 weeks, and 26 weeks
App diary using an 11-point numerical rating scale for pain intensity for 7 days Scores range from 0-10 where higher scores indicate a worse outcome
Adaptive Coping - Coping Attempts
时间窗: Baseline,12 weeks, and 26 weeks
Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome
次要结局
- Child Physical and Emotional Functioning - Parent Report, Physical Functioning(Baseline,12 weeks, and 26 weeks)
- Physical and Emotional Functioning - Fatigue(Baseline,12 weeks, and 26 weeks)
- Child Physical and Emotional Functioning - Parent Report, General Anxiety(Baseline,12 weeks, and 26 weeks)
- Child Physical and Emotional Functioning - Parent Report, Development(Baseline,12 weeks, and 26 weeks)
- Physical and Emotional Functioning - Mobility(Baseline,12 weeks, and 26 weeks)
- Patient Global Impression of Change(12 weeks and 26 weeks)
- Parent Psychological Distress(Baseline,12 weeks, and 26 weeks)
- Treatment Acceptability(2 months after starting treatment)
- Physical and Emotional Functioning - Depressive Symptoms(Baseline,12 weeks, and 26 weeks)
- Physical and Emotional Functioning - Anxiety(Baseline,12 weeks, and 26 weeks)
- Physical and Emotional Functioning - Peer Relationships(Baseline,12 weeks, and 26 weeks)
- Parent Protectiveness(Baseline,12 weeks, and 26 weeks)
- Physical and Emotional Functioning - Pain Interference(Baseline,12 weeks, and 26 weeks)
- Health Services Utilization(Baseline and 26 weeks)
- Child Physical and Emotional Functioning - Parent Report, Depression(Baseline,12 weeks, and 26 weeks)
- Treatment Experiences - Child(12 weeks and 26 weeks)
- Child Physical and Emotional Functioning - Parent Report, Social Functioning(Baseline,12 weeks, and 26 weeks)
- Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety(Baseline,12 weeks, and 26 weeks)
- Child Physical and Emotional Functioning - Parent Report, Family Functioning(Baseline,12 weeks, and 26 weeks)
研究者
Tonya Palermo
Professor, Anesthesiology and Pain Medicine
Seattle Children's Hospital